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| Name | Class |
|---|---|
| Nanjing University of Chinese Medicine, Xueping Zhou, Li Ren | UNKNOWN |
| University of Zagreb | OTHER |
| Health Center Zagreb East, Ljiljana Karadakic | UNKNOWN |
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The thirty-nine-week open-label clinical study investigates the efficacy of acupuncture for Knee Osteoarthritis (KOA) as adjunctive therapy to analgesics compared to analgesics only and assesses the effects after 9 and 24 weeks, with safety assessment provided.
The study seeks to find possible additional benefits of acupuncture on Kidney Deficiency (KD) while treating KOA with an acupuncture protocol designed to treat KOA following Traditional Chinese Medicine (TCM) theory, which connects KOA with KD as its root cause. The points prescription uses local and Kidney-related points to treat KOA.
The chronic conditions require a higher number of acupuncture treatments. This study will provide acupuncture treatments in three cycles, each three weeks long, with frequency three times weekly. Twenty-seven acupuncture treatments of KOA during fifteen weeks tend to improve KOA and KDS; symptoms are assessed in 10 successive time points, and treatment effects and effect persistence are analysed.
64 patients with symptomatic KOA are randomly allocated into the Acupuncture (A) or Control (C) group according to their permanent, unique, and coincidental Personal Identification Number, which is randomly given to all citizens in Croatia. Before the experiment starts, demographics and disease parameters of all participants are compared. To objectify acupuncture effects, the enrolled physiatrist's measures included knee measures at 3 time points: baseline, at the end of acupuncture (Week 15), and nine weeks later (Week 24). Subjective evaluations of symptoms are assessed by Western Ontario and McMaster University Arthritis Index (WOMAC) total and subscales scores, Numeric Rating Scale (NRS), and Kidney Deficiency Syndrome Questionnaire (KDSQ) every 3 weeks till the 24th week (9 assessments). Analgesics taken by participants (DRUG) in the last three days before the assessments are recorded. Acupuncture treatment was promised to all participants. Therefore, at Week 25, the between-group analysis ended, and the C group crossed over to receive the identical acupuncture protocol. The 10th assessment in Week 39 was used to estimate, by within-group analysis, the immediate effects of the acupuncture in group C and the effect persistence in group A.
The Lequesne index was introduced additionally at Week 24 as another measure of the knee's functional state.
KOA's high prevalence assures the trial's participation motivation of patients regarding associated pain and functional impairment. Besides pain and stiffness, patients experience muscle weakness, poor balance, and joint distortion in an advanced stage. KOA attacks the diseased ones at the age of 50. Pain worsens with joint loading and becomes relieved by rest. KOA supposes bones remodelling, cartilage thinning, synovial thickening, and joint space narrowing. The advanced stage is presented by joint instability, squaring, and even subluxation.
KOA involves both knees and the contributing symptoms of old age from the scope of Kidney deficiency syndromes, such as weakness, insomnia, depression, tinnitus, forgetfulness, feeling cold, hot, low back pain, thirst at night, and disturbed urination could be manifested.
The acupuncture treatment of KOA follows syndrome differentiation. The treatment principle distinguishes the deficient root (primary Kidney deficiency and secondary Blood deficiency) as the cause, and the excessive branch (knee bone Bi syndrome) when in empty Cou Li spaces, the external factor becomes entraped, consequently. An aspiration with treatment is to tonify the Kidney, nourish Qi, tonify and invigorate Blood, remove Damp and Cold by transferring them toward the deficiency rather than expelling, and relieve the channels and collaterals from the obstruction. Moreover, knee meridians should be dredged to improve knee symptoms by a simultaneous reinforcing-reducing technique on local points and reinforcing on KD-related points. Eventually, the improvements of KD indicate better life quality.
The study's design involves two groups: an acupuncture (A) group that receives acupuncture treatment adjunctive to analgesics, and a control (C) group that receives only analgesics. Participants were recruited from the target population of patients over 50 from 2 Family Medicine practices with confirmed KOA. The study sample was formed with inclusion and exclusion criteria. 64 patients were recruited. All medical data of the participants were available to the investigator. After fulfilling the SOAP form (Subjective, Objective, Assessment, Plan) and getting informed written consent, the study sample was randomly allocated into two groups by size of their permanent, unique eleven-digit long Personal Identification Numbers (OIB), which is assigned to all Croatian citizens. Its first ten digits are accidentally chosen, and the last is a control number. Every second participant ordered by the size of OIB belongs to the same group; odd ones belong to the A group, and even ones to the C group. Demographic and disease parameters are compared at baseline to determine if the groups are comparable. All study participants received analgesics and could modify dosages according to their needs. Analgesics were nonsteroidal anti-inflammatory drugs (NSAIDs) and/or tramadol. Taken analgesics were recorded at Weeks 0, 3, 6, 9, 12, 15, 18, 21, 24, and 39. The dose represents an average daily dose of analgesics from the last three days. The dose was recorded after conversion to the comparable dose of the selected representative (ibuprofen), the most prescribed one. The given data will be statistically processed and analyzed.
Patients in the A group started with acupuncture treatment in September 2021, with the first treatment cycle. Each of the 3 treatment cycles, in total, is three weeks long, each consists of 9 treatments, patients will receive acupuncture three times per week and the two adjacent acupuncture cycles are separated by three weeks without acupuncture.
Acupuncture treatment protocol includes local treatment points Dubi (ST-35), Neixiyan (EX-LE-4) and Heding (EX-LE-2), Xuehai (SP-10), Yanglingquan (GB-34), Yinlingquan (SP-9), Zusanli (ST-36), Sanyinjiao (SP-6), and points targeting Kidney deficiency syndrome Taixi (KI-3), Guanyuan (CV 4), and Shenshu (BL-23).
Disposable sterile acupuncture needles 0.30 × 40 mm are used. The depth and angle procedure predicted straight needling on 1-1.5 inches deep, with a mild reinforcing-reducing method for local points, further straight and 0.5-1 inch deep with the reinforcing method for points based on KD syndromes. Complete treatment lasts 30 minutes, and the manipulations are provided every 10 minutes, three times in total.
The sample size was calculated based on the Berman et al. (1999) study. The sample size was calculated by envisioning a two-sided test with unequal variances: type I error 0,05, power 0,95. Group sample sizes of 16 and 16 (i.e. complete study population of 32 subjects) achieve 95,78% power to reject the null hypothesis of equal means and with a significance level (alpha) of 0,050 using a two-sided two-sample unequal-variance t-test.
From a longer treatment period of this study and higher participants' drop-off expected, the population was doubled to 64 subjects in total.
Research methods were determined upon the clinical question "Could the prolonged design of acupuncture treatments on patients with knee osteoarthritis (KOA) decrease pain and improve the function of the knee joints and additionally achieve positive effects on the debilitating symptoms of a Kidney deficiency as a root cause of KOA, measured by recognized questionnaires?".
Evaluation of the therapeutic effects of acupuncture on KOA included WOMAC, VAS, KDSQ scores, and DRUG at Weeks 0, 3, 6, 9, 12, 15, 18, 21, 24, and 39. WOMAC is a renowned questionnaire for KOA evaluation. It measures 5 items for pain, 2 for stiffness, and 17 for functional limitation. VAS is a continuous numeric rating scale of 100 mm in length that is widely used for pain intensity assessment. The KDSQ questionnaire is a valid and reliable measure constructed in 2012 to evaluate Kidney Yin and Yang deficiency syndromes of Hong Kong Chinese middle-aged women by Chen et al. KDSQ represents a valid questionnaire for KD assessment in this study population.
From a total of 10 assessments, the first 9 compared scores between groups A and C. Participants were promised to receive equal acupuncture treatment if they were randomised into the C group. So, group C crossed over to receive the identical protocol from Week 25 to 39, and the 10th assessment was added to both groups of participants to estimate the immediate effects of the acupuncture treatment in the C group and estimate treatment effect persistence in the A group over 24 weeks, in a within-group manner. The physiatrist's assessments at 3 time-points (baseline, 15th Week, and 24th Week) include the standard physiatrist KOA measurements (knee and thigh circumference, range of motion of the knee). The Lequesne index was added as the knee's functional state measure in Week 24.
Data is stored electronically with secured and restricted access. Data transfer will be encrypted, and all data that could identify individuals has been removed.
Study analysis serves to process the effects of acupuncture treatment. Baseline data are obtained before the experiment starts. Besides immediate effects, effects persistence was assessed at Weeks 24 (9 weeks after acupuncture of group A ended) and 39. WOMAC total score at the end of the acupuncture protocol (Week 15) is a primary outcome, while WOMAC subscales, VAS, and KDSQ scores, DRUG at Weeks 15, 24 and 39, and persistence of WOMAC total were secondary and supportive of the primary one. Secondary outcome measures include physiatrists' measures and the Lequesne index as well. Effect sizes are calculated from data comparison to the control group up to Week 24 or baseline at Week 39. Analyses were performed on 64 participants, randomised for the intention-to-treat (ITT) analysis using the maximum available data set (i.e. excluding the missing values) from repeated measures of variables of interest and their variances. ITT analysis, excluding missing values, was selected regarding dropouts that emerged in the study, completely random without any causal clustering. Dropouts produced missing values. Omitting missing values can compromise the statistics and produce bias. Therefore, sensitivity analyses were provided to compare those who dropped out and those who completed the study to determine if data significantly differed. Also, a test calculation with the Last observation carried forward technique (LOCF) with the imputed last observed value in the missing one was performed to check if the obtained effects still stand. All statistical tests are two-sided. The Shapiro-Wilk test tests the normality distribution. The non-parametric Mann-Whitney U test was used for comparability testing with 95% power and α=0,05. The main efficacy indicators tested the comparability of the groups with the Mann-Whitney U test and quantified observed effects by mean differences and Cohen's d.
A participant will be considered to have withdrawn from the trial when consent is revoked or if the participant cannot be contacted or located. Participants will not be withdrawn from the trial for protocol violations. Withdrawal due to an adverse event should be distinguished from withdrawal due to insufficient response.
All adverse events will be recorded in the Adverse Event Report Form at every treatment. If this happens, an adverse event will be followed until its resolution. The serious adverse event must be reported to the Medical Ethics Committee.
It is expected to relieve pain and increase joint mobility, along with alleviating KD and reducing the use of analgesics and confirming the safety of acupuncture.
This is a prospective, interventional, randomized, open-label, controlled trial. It is supported by recent scholarly, peer-reviewed literature. The research method reflects the approach needed to answer the research questions. Research is addressing a gap in the literature that would contribute new findings. The research topic is based on a tangible and cited problem. The research collects and analyses the data, any deviations are documented and approved by NJUCM. The study was designed originally. The acupuncture treatment plan for KOA is designed with the assistance of Professor Xueping Zhou. The study will be conducted in a Family Medicine practice by the experimenter. All financial and operating burdens will be funded from practice resources.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture Group | Experimental | Participants in Acupuncture group will get acupuncture treatments to their symptomatic knee/knees according to the study protocol. Acupuncture will be provided to participants in three cycles, each three weeks duration, with frequency three times weekly. Period between the cycles is three weeks long. Participants will get acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to participant symptoms intensity. Participants and investigator are not blinded for treatment type. |
|
| Control Group | Active Comparator | Participants in Control group will get their standard conventional treatment (analgesics) which dose could vary according to participant symptoms intensity. Participants and investigator are not blinded for treatment type. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Procedure | Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment is 30 minutes. All treatments will be equal. |
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC Total in Week 15 | The Western Ontario and McMaster University Osteoarthritis Index (WOMAC) total score is the sum of the three subscales: pain, stiffness, and functional disability. The minimum value is 0, and the maximum value is 96, where the lower score/value represents a better outcome, and the higher score/value represents a worse outcome. | Week 15 |
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC Pain in Week 15 | Western Ontario and McMaster University Osteoarthritis (WOMAC) pain subscale, separated from the WOMAC index, evaluates knee OA pain by participants. It comprises 5 questions for pain assessed by a 5-point Likert scale ranging from minimal 0 to maximal 20 points. A bigger score presents a worse outcome, and a lower score relates to a better outcome. | Week 15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Svijetlana Perculija Durdevic, M.D. | Family Medicine Practice Svijetlana Perculija Durdevic, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Family Medicine Practice Svijetlana Perculija Durdevic, MD | Zagreb | 10000 | Croatia |
IPD that underlies the results reported in this article after deidentification (text, tables, figures, and appendices) for qualified researchers. Approval of the request is a prerequisite to the sharing of data.
3 months following publication, ending 3 years following article publication
Access to trial IPD can be requested by a qualified researcher engaging in independent scientific research.
For more information or to submit a request please contact svijetlana.perculija.durdevic@outlook.com
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In the pre-assignment period, all 64 enrolled participants were assigned in a concealed manner to the A or C group.
The recruitment process was carried out from January 2021 to August 2021. The recruitment was performed at the Family Medicine practice, run by the investigator, who has access to the database of four thousand patients from two practices. From the 4000 patients, 180 made the target population by criteria ≥50 years and confirmed KOA from a computer database. A study population of 64 participants was made by applying the inclusion and exclusion criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Acupuncture Group | 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to analgesics, whose dose could vary according to the participant's need. Participants and investigators were not blinded by treatment type, but assessors were blinded about the fact to which group participants belonged. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete treatment lasted 30 minutes. Conventional Medical Treatment: Participants took analgesics, prescribed by their general practitioner. They could modify the analgesics' dose according to the intensity of their symptoms. |
| FG001 | Control Group | 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 1-24, Between Group Analysis |
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| Week 25-39, Within Group Analysis |
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| ID | Title | Description |
|---|---|---|
| BG000 | Acupuncture Group | Participants in the Acupuncture (A) group got acupuncture treatments for their knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with a frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) whose dose varied according to participant symptoms intensity. The participants and investigator were not blinded by treatment type. The assessors were blinded for the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles were manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The average age of participants was 64 years, ranging from 50 to 81 years because the inclusion criteria for participant enrolment in the study was the age of 50 years or older. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | WOMAC Total in Week 15 | The Western Ontario and McMaster University Osteoarthritis Index (WOMAC) total score is the sum of the three subscales: pain, stiffness, and functional disability. The minimum value is 0, and the maximum value is 96, where the lower score/value represents a better outcome, and the higher score/value represents a worse outcome. | WOMAC total in Week 15 estimates the immediate treatment effects of acupuncture on pain, stiffness and knee function when acupuncture treatments ended in a between-groups A and C analysis. | Posted | Mean | Standard Deviation | score on a scale | Week 15 |
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The whole experiment lasted 39 weeks. The treatment protocol for every participant lasted 15 weeks. The treatment protocol comprises 3 cycles 3 weeks long, and between two cycles was a 3-week break. Participants could participate in 27 acupuncture sessions for 15 weeks in 3-times-weekly rhythm.
Every participant had his own form for adverse events where the observer fulfilled adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acupuncture Group | 32 randomised participants were allocated to the Acupuncture group to get acupuncture treatments for both knees according to the study protocol. Acupuncture was provided to participants in three cycles, each three weeks long, with the frequency of three times weekly. The period between the cycles was three weeks long. Participants got acupuncture as adjunctive therapy to conventional medical treatment (analgesic therapy) which dose could vary according to the participant's symptoms intensity. Participants and investigators were not blinded by treatment type, but assessors were blinded by the fact to which group participants belong. Acupuncture: Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment was 30 minutes. All treatments were equally long. Conventional Medical Treatment: Participants took their standard conventional medical treatment (analgesics). Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| suprapatellar knee jount effusion (M13.1) | Injury, poisoning and procedural complications | ICD 10 | Non-systematic Assessment | at suprapatellar region effusion happened after treatment on the pace of pricking the skin, the change subsided within a few days |
The assessor who did the physiatrist measurement was sick during 3rd assessment and because of that 3rd measurement, which differs in both groups from the previous two, was done with another assessor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Svijetlana Perculija Durdevic, MD, family medicine specialist, acupuncturist | Family Medicine Practice Svijetlana Perculija Durdevic, MD, Ninska 10, Sesvete | 00385913302507 | svijetlana.perculija.durdevic@outlook.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 10, 2025 | May 4, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 11, 2025 | May 4, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 3, 2022 | Jun 17, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D000700 | Analgesics |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
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A randomized, controlled, interventional, prospective.
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The assessor of the physiatrists' measures and the assessor in charge of helping fill in WOMAC, VAS, KDSQ, DRUG, and Lequesne index were blind to the fact to which group participants belonged.
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| Conventional Medical Treatment | Drug | Participants could take their standard conventional medical treatment or analgesics. Analgesics therapy is prescribed by their general practitioner. The dose of analgesics could be modified according to participants' symptoms intensity. |
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| WOMAC Stiffness in Week 15 | Western Ontario and McMaster University Osteoarthritis (WOMAC) stiffness subscale, separated from the WOMAC index, and evaluate knee OA stiffness by participants. It comprises 2 questions for stiffness assessed by a 5-point Likert scale between the range from minimal 0 to maximal 8 points. A bigger score presents a worse outcome, and a lower score relates to a better result. WOMAC stiffness measures the stiffness of the knees. | Week 15 |
| WOMAC Functional Disability in Week 15 | Western Ontario and McMaster University Osteoarthritis (WOMAC) functional disability subscale, separated from the WOMAC index, evaluates knee OA functional disability by participants' estimation. It comprises 17 items for functional disability assessment by a 5-point Likert scale ranging from minimal 0 to maximal 68 points. A bigger score presents a worse outcome, and a lower score relates to a better result. WOMAC functional disability measures climbing, rising from a chair/bed, standing, bending, walking, getting in/out of a car/bath/toilet, shopping, putting on socks, sitting and difficulties in domestic duties. | Week 15 |
| VAS in Week 15 | Visual Analogue Scale (VAS) assesses knee OA pain intensity, ranging from 0 to 100; the lower value represents a better outcome, and the higher a worse outcome. | Week 15 |
| KDSQ in Week 15 | The Kidney Deficiency Syndrome Questionnaire (KDSQ) assesses the intensity of Kidney deficiency (KD) symptoms; the minimum value is 0, and the maximum is 69. A lower score/value represents a better outcome, and a higher score/value represents a worse outcome. This measure represents the effect of acupuncture treatment on KD. | Week 15 |
| DRUG in Week 15 | DRUG is a measure that represents analgesics taken by participants, including various non-steroid anti-inflammatory drugs (NSAIDS) and/or tramadol. Recorded analgesics' doses from the last three days before assessment were recalculated in the comparable dose of the selective representative (ibuprofen) and converted into equivalent dose of milligrams of ibuprofen-ibuprofen equivalent units (IBU). DRUG's units of measure are IBU (units) on the scale ranging from 0 IBU to 4.500 IBU. DRUG decreasement represents a better therapeutic outcome, and an increase in DRUG represents a worse therapeutic outcome. All participants could self-manage the dosage according to their pain. | Week 15 |
| Active Extension L and R Knees in Week 15 | The active extension of the left (L) and right (R) knees in Week 15 is an objective measure taken by an independent physiatrist with a goniometer, expressed on a scale with degrees of a goniometer angle as units. Knee active extension ranges between 0 and 5 degrees: the higher scores represent knee laxity/instability, and the negative scores represent knee flexion contraction. The higher values represent worse outcomes, and the lower values represent better outcomes. | Week 15 |
| Active Flexion L and R Knees in Week 15 | Active flexion of left (L) and right (R) knees in Week 15 is an objective measure provided by an independent physiatrist with a goniometer, expressed on a scale with degrees of a goniometer angle (units). Knee active flexion ranges from 0 to a maximum of 135 degrees; the lower score/value represents a worse outcome, and the higher score/value a better one. | Week 15 |
| Circumference of L and R Upper Leg in Week 15 | Circumference of the left (L) and right (R) upper leg in Week 15 is an objective measure, assessed by an independent physiatrist, at the thigh 15 centimetres above the patellar superior margin, measured with a tape measure. The unit of measure is a centimetre (unit) on the measuring tape (scale) with a range from 0 to 100 centimetres. This measure represents a measure of muscular strength or atrophy. Higher values indicate better outcomes from higher muscular volume, and decreased values indicate worse outcomes from weaker muscular volume. | Week15 |
| Circumference of L and R Knees in Week 15 | Circumference of left (L) and right (R) knees at Week 15 is an objective measurement taken by an independent physiatrist; the measure includes the difference in circumference of the knees measured with a tape measure at the middle of the patellae. The unit of measure is a centimetre (unit) on the measuring tape (scale) with a range from 0 to 100 centimetres. This measure represents knee inflammation and joint deformation (abnormal bone growth). Increased values indicate worse outcomes from a higher level of knee inflammation/deformation, and decreased values indicate better outcomes from a lower level of knee inflammation/deformation. | Week 15 |
| WOMAC Total in Week 24 | Western Ontario and McMaster University Osteoarthritis (WOMAC) index's total score is a sum of all three subscales for pain, stiffness, and functional disability, the minimum value is 0, and the maximum value is 96; the lower score/value represents a better outcome, and a higher score/value represents a worse outcome | Week 24 |
| WOMAC Pain in Week 24 | Western Ontario and McMaster University Osteoarthritis (WOMAC) pain subscale, separated from the WOMAC index, evaluates OA pain by participants. It comprises 5 questions for pain assessed by a 5-point Likert scale, ranging from minimal 0 to maximal 20 points. A bigger score presents a worse outcome, and a lower score relates to a better one. | Week 24 |
| WOMAC Stiffness in Week 24 | Western Ontario and McMaster University Osteoarthritis (WOMAC) stiffness subscale, separated from the WOMAC index, evaluates knee OA stiffness by participants. It comprises 2 questions for stiffness assessed by a 5-point Likert scale ranging from minimal 0 to maximal 8 points. A bigger score represents a worse outcome, and a lower score relates to a better result. WOMAC stiffness measures the stiffness of the knees. | Week 24 |
| WOMAC Functional Disability in Week 24 | Western Ontario and McMaster University Osteoarthritis (WOMAC) functional disability subscale, separated from the WOMAC index, evaluates knee OA functional disability by participants' estimation. It comprises 17 items of functional disability assessment by a 5-point Likert scale ranging from minimal 0 to maximal 68 points. A bigger score presents a worse outcome, and a lower score relates to a better result. WOMAC functional disability measures climbing, rising from a chair/bed, standing, bending, walking, getting in/out of a car/bath/toilet, shopping, putting on socks, sitting, and difficulties in domestic duties. | Week 24 |
| VAS in Week 24 | Visual Analogue Scale (VAS) assesses knee OA pain intensity, ranging from 0 to 100; the lower value represents a better outcome, and the higher a worse outcome. | Week 24 |
| KDSQ in Week 24 | The Kidney Deficiency Syndrome Questionnaire (KDSQ) assesses the intensity of kidney deficiency symptoms; the minimum value is 0, and the maximum is 69. A lower score/value represents a better outcome, and a higher score/value represents a worse outcome. This measure represents the effect of acupuncture treatment on Kidney deficiency (KD). | Week 24 |
| DRUG in Week 24 | DRUG is a measure that represents analgesics taken by participants, including various non-steroid anti-inflammatory drugs (NSAIDS) and/or tramadol. Recorded analgesics' doses from the last three days before assessment were recalculated in the comparable dose of the selective representative (ibuprofen) and converted into equivalent dose of milligrams of ibuprofen-ibuprofen equivalent units (IBU). DRUG's units of measure are IBU (units) on the scale ranging from 0 IBU to 4.500 IBU. DRUG decreasement represents a better therapeutic outcome, and an increase in DRUG represents a worse therapeutic outcome. All participants could self-manage the dosage according to their pain. | Week 24 |
| Active Extension L and R Knee in Week 24 | The active extension of the left (L) and right (R) knees in Week 15 is an objective measure taken by an independent physiatrist with a goniometer, expressed on a scale with degrees of a goniometer angle as units. Knee active extension ranges between 0 and 5 degrees: the higher scores represent knee laxity/instability, and the negative scores represent knee flexion contraction. The higher values represent worse outcomes, and the lower values represent better outcomes. | Week 24 |
| Active Flexion L and R Knees in Week 24 | Active flexion of left (L) and right (R) knees in Week 15 is an objective measure provided by an independent physiatrist with a goniometer, expressed on a scale with degrees of a goniometer angle (units). Knee active flexion ranges from 0 to a maximum of 135 degrees; the lower score/value represents a worse outcome, and the higher score/value a better one. | Week 24 |
| Circumference of L and R Upper Leg in Week 24 | Circumference of the left (L) and right (R) upper leg in Week 24 is an objective measure, assessed by an independent physiatrist, at the thigh 15 centimetres above the patellar superior margin, measured with a tape measure. The unit of measure is a centimetre (unit) on the measuring tape (scale) with a range from 0 to 100 centimetres. This measure represents a measure of muscular strength or atrophy. Higher values indicate better outcomes from higher muscular volume, and decreased values indicate worse outcomes from weaker muscular volume. | Week 24 |
| Circumference of L and R Knee in Week 24 | Circumference of the left (L) and right (R) upper leg in Week 24 is an objective measure, assessed by an independent physiatrist, at the thigh 15 centimetres above the patellar superior margin, measured with a tape measure. The unit of measure is a centimetre (unit) on the measuring tape (scale) with a range from 0 to 100 centimetres. This measure represents a measure of muscular strength or atrophy. Higher values indicate better outcomes from higher muscular volume, and decreased values indicate worse outcomes from weaker muscular volume. | Week 24 |
| WOMAC Total in Week 39 | Western Ontario and McMaster University Osteoarthritis (WOMAC) total at the Added assessment at Week 39 in the crossover part compared to pre-experimental baseline value. The total score is a sum of all three subscales: pain, stiffness, and functional limitation. The minimum value is 0, and the maximum value is 96, where the lower score/value represents a better outcome, and a higher score/value represents a worse outcome. | Week 39 |
| WOMAC Pain in Week 39 | The Western Ontario and McMaster University Osteoarthritis (WOMAC) pain subscale, selected from the WOMAC index, evaluates knee OA pain by participants. It comprises 5 questions for pain assessed by a 5-point Likert scale, ranging from minimal 0 to maximal 20 points. A bigger score presents a worse outcome, and a lower score relates to a better one. | Week 39 |
| WOMAC Stiffness in Week 39 | Western Ontario and McMaster University Osteoarthritis (WOMAC) stiffness subscale, separated from the WOMAC index, evaluates knee OA stiffness by participants. It comprises 2 questions for stiffness assessed by a 5-point Likert scale ranging from minimal 0 to maximal 8 points. A bigger score represents a worse outcome, and a lower score relates to a better result. WOMAC stiffness measures the stiffness of the knees. | Week 39 |
| WOMAC Functional Disability in Week 39 | Western Ontario and McMaster University Osteoarthritis (WOMAC) functional disability subscale, separated from the WOMAC index, evaluates knee OA functional disability by participants' estimation. It comprises 17 items for functional disability assessment by a 5-point Likert scale ranging from minimal 0 to maximal 68 points. A bigger score presents a worse outcome, and a lower score relates to a better result. WOMAC functional disability measures climbing, rising from a chair/bed, standing, bending, walking, getting in/out of a car/bath/toilet, shopping, putting on socks, sitting and difficulties in domestic duties. | Week 39 |
| VAS in Week 39 | Visual Analogue Scale (VAS) assesses knee OA pain intensity, ranging from 0 to 100; the lower value represents a better outcome, and the higher a worse outcome. This measure estimates the treatment effect of acupuncture on knee pain in Week 39 separately for groups A and C. | Week 39 |
| KDSQ in Week 39 | The Kidney Deficiency Syndrome Questionnaire (KDSQ) assesses the intensity of Kidney deficiency symptoms; the minimum value is 0, and the maximum is 69. A lower score/value represents a better outcome, and a higher score/value represents a worse outcome. This outcome represents the treatment effect of acupuncture on Kidney deficiency symptoms for both groups separately. | Week 39 |
| DRUG by Added Assessment in Week 39, Crossover Part | DRUG is a measure that represents analgesics taken by participants, including various non-steroid anti-inflammatory drugs (NSAIDS) and/or tramadol. Recorded analgesics' doses from the last three days before assessment were recalculated in the comparable dose of the selective representative (ibuprofen) and converted into equivalent dose of milligrams of ibuprofen-ibuprofen equivalent units (IBU). DRUG's units of measure are IBU (units) on the scale ranging from 0 IBU to 4.500 IBU. DRUG decreasement represents a better therapeutic outcome, and an increase in DRUG represents a worse therapeutic outcome. All participants could self-manage the dosage according to their pain. | Week 39 |
| Lequesne Index in Week 24, Between-group Analysis | The Lequesne index is an algofunctional index of knee osteoarthritis that comprises three sections. Its score ranges from a minimal 0 (no pain and disability) to 24 (the greatest pain and disability). This index is added to the study in Week 24 as an additional objective measure. It measures pain severity with 5 questions, walking distance with 2 questions, and activities of daily living with 4 questions. | Week 24 |
| NOT COMPLETED |
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| BG001 | Control Group | Participants in the Control (C) group got their standard conventional treatment (analgesics) whose dose could vary according to the participants' symptoms intensity. Participants and investigator were not blinded for treatment type. The assessors were blinded for the fact to which group participants belong. Conventional Medical Treatment: Participants took their standard conventional medical treatment or analgesics. Analgesics therapy was prescribed by their general practitioner. The participants modified the dose of analgesics according to the intensity of their symptoms. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | The study sample of participants included 15 (23.4%) males and 49 (76.6%) females. Knee osteoarthritis occurs more often in females. | Count of Participants | Participants |
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| Race (NIH/OMB) | All participants from the study belong to the white race. | Count of Participants | Participants |
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| Body Mass Index (BMI), Continuous | Participants' average body mass index (BMI) in the study was 31.0 ( 31.4 in A and 30.6 in C group). The values of BMI range from 21,0 to 47,5 among participants. Obesity is one of the risk factors for knee osteoarthritis. | Mean | Standard Deviation | kg/m2 |
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| Kellgren-Lawrence (K-L) grade, Categorical | The average Kellgren-Lawrence (K-L) score was 3 in both groups, the scores range from 2 to 4 because a score of 2 was the minimum score for enrolling participants in the study. The grading of K-L participants could have shifted toward higher grades if the radiographs had been renewed before the start of the study. Existing patient recordings were used in the study. K-L grade was used here more for disease confirmation purposes. | Count of Participants | Participants |
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| WOMAC total, Continuous | Western Ontario and McMaster University Osteoarthritis Index (WOMAC) is a renowned questionnaire used by health professionals to evaluate the condition of patients with KOA. It is an interval scale with a range from minimal 0 to maximal 96 points, a higher score supposes advanced osteoarthritis or a worse outcome and a lower score signifies better OA outcome presentation. It comprises 5 questions for pain (0-20), 2 for stiffness (0-8) and 17 for functional limitation (0-68) which all summed provide WOMAC total. | Mean | Standard Deviation | score on a scale |
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| WOMAC pain, Continuous | Western Ontario and McMaster University Osteoarthritis (WOMAC) pain subscale of the WOMAC index evaluates OA pain by participants. It comprises 5 questions for pain assessed by a 5-point Likert scale between range from minimal 0 to maximal 20 points. A bigger score presents a worse outcome and a lower score relates to a better outcome. | Mean | Standard Deviation | score on a scale |
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| WOMAC stiffness, Continuous | Western Ontario and McMaster University Osteoarthritis (WOMAC) stiffness subscale of the WOMAC index and evaluate knee OA stiffness by participants. It comprises 2 questions for stiffness assessed by a 5-point Likert scale between the range from minimal 0 to maximal 8 points. A bigger score presents a worse outcome and a lower score relates to a better result. WOMAC stiffness measures the stiffness of the knees. | Mean | Standard Deviation | score on a scale |
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| WOMAC functional disability, Continuous | Western Ontario and McMaster University Osteoarthritis (WOMAC) functional disability subscale of the WOMAC index evaluates KOA functional disability by participants. It comprises 17 questions for functional disability assessed by a 5-point Likert scale between the range from minimal 0 to maximal 68 points. A bigger score presents a worse outcome and a lower score relates to a better result.WOMAC functional disability measures the functional disability of the knees. | Mean | Standard Deviation | score on a scale |
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| VAS, Continuous | VAS continuous scale of 100 mm in length is a widely used and recognized scale for pain intense assessment. The number of millimetres on the scale range from 0 to 100, where 0 represents no pain and 100 represents the maximal possible pain. The one millimetre represents one unit of scale. The scale was divided into 10 parts for easier quantifying knee pain by participants. | Median | Standard Deviation | score on a scale |
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| KDSQ, Continuous | The Kidney Deficiency Syndrome Questionnaire (KDSQ) is a valid reliable measure for the evaluation of KDS. Of all 39 symptoms of Kidney deficiency, the authors excluded symptoms related to childhood and the male gender. KDSQ represents a valid form for the evaluation of KDS for this sample when the question about vaginal dryness was excluded. KDSQ comprises 21 questions, which are evaluated in the form of a 4-point Likert scale, about various related symptoms and traits. The maximal score is 69, a higher score relates to a worse outcome, and a lower score signifies a better condition/outcome. | Mean | Standard Deviation | score on a scale |
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| DRUG /IBU, Continuous | DRUG is an average daily dose of analgesics in the last three days before assessment, according to the statement of the participants; various kinds of analgesics used were recalculated in a comparable dose of the selected representative (ibuprofen), as the most prescribed one. DRUG is expressed in ibuprofen equivalent milligram units (IBU): various analgesic doses were converted into comparable doses of ibuprofen according to specified minimal, maximal, and medium daily analgesic doses, frequently used in daily clinical work. Baseline values range from 0 to 4400 mg IBU among participants. | Mean | Standard Deviation | milligram-equivalent of ibuprofen |
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| Active flexion L and R knees, Continuous | Knee active flexion is measured with a goniometer and expressed in degrees of angle (deg.). The maximal knee active flexion is 135 degrees, and the minimal is 0 degrees. A lower value represents a worse outcome, and a higher value represents a better outcome. Knee active flexion and knee active extension form the knee's range of movement. | Some participants did not respond to the measurement. | Mean | Standard Deviation | degree of angle |
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| Active extension L and R knee, Continuous | Knee active extension is measured with a goniometer and is expressed in degrees of angle (deg.). The normal range is from 0 to 5 degrees, where the reduced extension represents the flexion contracture. Possible values out of the range present knee laxity (if >5 degrees) or flexion contracture (if <0 degrees). Higher deviation represents worse outcomes, and lower deviation represents better outcomes. Values between 0 and 5 degrees are in the physiological range. | Some participants did not respond to the measurement. | Mean | Standard Deviation | degree of angle |
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| Circumference of L and R upper leg, Continuous | The circumference of the thigh, at 15 centimetres above the patellar superior margin, by a measuring tape. It is an objective knee physical measure. The unit of measure is a centimetre (cm). In the observed periods, the measure estimates muscular strength or knee activity. Increased values indicate increased muscular strength/knee function (better outcomes), and decreased values indicate worse muscular strength /knee function (worse outcomes). | Some participants did not respond to the measurement. | Mean | Standard Deviation | centimeter |
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| Circumference of L and R knee, Continuous | Circumference of the knee is an objective measure performed with a measuring tape. The unit of measure is a centimeter (cm). The knee could be enlarged due to obesity, inflammation and deformation (abnormal bone growth). Increased values indicate a higher level of knee inflammation /deformation and obesity. | Some participants did not respond to the measurement. | Mean | Standard Deviation | centimeter |
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| OG001 | C Group in Week 15 | 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms. |
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| Secondary | WOMAC Pain in Week 15 | Western Ontario and McMaster University Osteoarthritis (WOMAC) pain subscale, separated from the WOMAC index, evaluates knee OA pain by participants. It comprises 5 questions for pain assessed by a 5-point Likert scale ranging from minimal 0 to maximal 20 points. A bigger score presents a worse outcome, and a lower score relates to a better outcome. | WOMAC pain in Week 15 estimates the immediate treatment effects of acupuncture at Week 15 on knee OA pain after acupuncture treatments were completed in a between-groups A and C analysis. | Posted | Mean | Standard Deviation | score on a scale | Week 15 |
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| Secondary | WOMAC Stiffness in Week 15 | Western Ontario and McMaster University Osteoarthritis (WOMAC) stiffness subscale, separated from the WOMAC index, and evaluate knee OA stiffness by participants. It comprises 2 questions for stiffness assessed by a 5-point Likert scale between the range from minimal 0 to maximal 8 points. A bigger score presents a worse outcome, and a lower score relates to a better result. WOMAC stiffness measures the stiffness of the knees. | WOMAC stiffness in Week 15 estimates the immediate treatment effects of acupuncture on knee OA stiffness after acupuncture treatments were completed at Week 15 in a between-groups A and C analysis. | Posted | Mean | Standard Deviation | score on a scale | Week 15 |
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| Secondary | WOMAC Functional Disability in Week 15 | Western Ontario and McMaster University Osteoarthritis (WOMAC) functional disability subscale, separated from the WOMAC index, evaluates knee OA functional disability by participants' estimation. It comprises 17 items for functional disability assessment by a 5-point Likert scale ranging from minimal 0 to maximal 68 points. A bigger score presents a worse outcome, and a lower score relates to a better result. WOMAC functional disability measures climbing, rising from a chair/bed, standing, bending, walking, getting in/out of a car/bath/toilet, shopping, putting on socks, sitting and difficulties in domestic duties. | WOMAC functional disability in Week 15 estimates the immediate treatment effects of acupuncture on knee OA functional disability after acupuncture treatments were completed at Week 15 in a between-groups A and C analysis. | Posted | Mean | Standard Deviation | score on a scale | Week 15 |
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| Secondary | VAS in Week 15 | Visual Analogue Scale (VAS) assesses knee OA pain intensity, ranging from 0 to 100; the lower value represents a better outcome, and the higher a worse outcome. | VAS 15 measure estimates the treatment effect of acupuncture on KOA pain at the acupuncture treatment completion time point, analysed between the A and C groups. | Posted | Mean | Standard Deviation | score on a scale | Week 15 |
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| Secondary | KDSQ in Week 15 | The Kidney Deficiency Syndrome Questionnaire (KDSQ) assesses the intensity of Kidney deficiency (KD) symptoms; the minimum value is 0, and the maximum is 69. A lower score/value represents a better outcome, and a higher score/value represents a worse outcome. This measure represents the effect of acupuncture treatment on KD. | KDSQ in Week 15 estimates the treatment effect of acupuncture on Kidney deficiency symptoms at the end of the acupuncture treatments, analysed between the A and C groups. | Posted | Mean | Standard Deviation | score on a scale | Week 15 |
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| Secondary | DRUG in Week 15 | DRUG is a measure that represents analgesics taken by participants, including various non-steroid anti-inflammatory drugs (NSAIDS) and/or tramadol. Recorded analgesics' doses from the last three days before assessment were recalculated in the comparable dose of the selective representative (ibuprofen) and converted into equivalent dose of milligrams of ibuprofen-ibuprofen equivalent units (IBU). DRUG's units of measure are IBU (units) on the scale ranging from 0 IBU to 4.500 IBU. DRUG decreasement represents a better therapeutic outcome, and an increase in DRUG represents a worse therapeutic outcome. All participants could self-manage the dosage according to their pain. | DRUG in Week 15 estimates the treatment effect of acupuncture on knee OA pain at the end of acupuncture treatment, analysed between groups A and C. | Posted | Mean | Standard Deviation | milligrams-equivalent of ibuprofen(IBU) | Week 15 |
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| Secondary | Active Extension L and R Knees in Week 15 | The active extension of the left (L) and right (R) knees in Week 15 is an objective measure taken by an independent physiatrist with a goniometer, expressed on a scale with degrees of a goniometer angle as units. Knee active extension ranges between 0 and 5 degrees: the higher scores represent knee laxity/instability, and the negative scores represent knee flexion contraction. The higher values represent worse outcomes, and the lower values represent better outcomes. | Active extension of L and R knees in Week 15 represents the treatment effect of acupuncture on the knee OA at the completed acupuncture treatment time point in Week 15, compared between groups A and C. | Posted | Mean | Standard Deviation | degrees of a goniometer angle | Week 15 |
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| Secondary | Active Flexion L and R Knees in Week 15 | Active flexion of left (L) and right (R) knees in Week 15 is an objective measure provided by an independent physiatrist with a goniometer, expressed on a scale with degrees of a goniometer angle (units). Knee active flexion ranges from 0 to a maximum of 135 degrees; the lower score/value represents a worse outcome, and the higher score/value a better one. | Active flexion of L and R knees in Week 15 represents the treatment effect of acupuncture on knee function at the end of acupuncture treatment, Week 15, between groups A and C at Week 15. | Posted | Mean | Standard Deviation | degrees on a goniometer angle | Week 15 |
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| Secondary | Circumference of L and R Upper Leg in Week 15 | Circumference of the left (L) and right (R) upper leg in Week 15 is an objective measure, assessed by an independent physiatrist, at the thigh 15 centimetres above the patellar superior margin, measured with a tape measure. The unit of measure is a centimetre (unit) on the measuring tape (scale) with a range from 0 to 100 centimetres. This measure represents a measure of muscular strength or atrophy. Higher values indicate better outcomes from higher muscular volume, and decreased values indicate worse outcomes from weaker muscular volume. | This measure estimates the treatment effect of acupuncture on knee function at the end of the acupuncture treatment time point in Week 15, in the between-groups A and C analysis. | Posted | Mean | Standard Deviation | centimeters | Week15 |
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| Secondary | Circumference of L and R Knees in Week 15 | Circumference of left (L) and right (R) knees at Week 15 is an objective measurement taken by an independent physiatrist; the measure includes the difference in circumference of the knees measured with a tape measure at the middle of the patellae. The unit of measure is a centimetre (unit) on the measuring tape (scale) with a range from 0 to 100 centimetres. This measure represents knee inflammation and joint deformation (abnormal bone growth). Increased values indicate worse outcomes from a higher level of knee inflammation/deformation, and decreased values indicate better outcomes from a lower level of knee inflammation/deformation. | Circumference of L and R knees in Week 15 estimates the treatment effect of acupuncture on knee osteoarthritis at the end of the acupuncture treatment time point, analysed between groups A and C. | Posted | Mean | Standard Deviation | centimeters | Week 15 |
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| Secondary | WOMAC Total in Week 24 | Western Ontario and McMaster University Osteoarthritis (WOMAC) index's total score is a sum of all three subscales for pain, stiffness, and functional disability, the minimum value is 0, and the maximum value is 96; the lower score/value represents a better outcome, and a higher score/value represents a worse outcome | WOMAC total in Week 24 represents the treatment effect of acupuncture on pain, stiffness, and function at Assessment 9, in Week 24, nine weeks after acupuncture treatment ended, and was analysed between groups A and C. | Posted | Mean | Standard Deviation | score on a scale | Week 24 |
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| Secondary | WOMAC Pain in Week 24 | Western Ontario and McMaster University Osteoarthritis (WOMAC) pain subscale, separated from the WOMAC index, evaluates OA pain by participants. It comprises 5 questions for pain assessed by a 5-point Likert scale, ranging from minimal 0 to maximal 20 points. A bigger score presents a worse outcome, and a lower score relates to a better one. | WOMAC pain in Week 24, nine weeks after acupuncture treatment ended, was analysed between groups A and C. | Posted | Mean | Standard Deviation | score on a scale | Week 24 |
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| Secondary | WOMAC Stiffness in Week 24 | Western Ontario and McMaster University Osteoarthritis (WOMAC) stiffness subscale, separated from the WOMAC index, evaluates knee OA stiffness by participants. It comprises 2 questions for stiffness assessed by a 5-point Likert scale ranging from minimal 0 to maximal 8 points. A bigger score represents a worse outcome, and a lower score relates to a better result. WOMAC stiffness measures the stiffness of the knees. | WOMAC stiffness in Week 24, nine weeks after acupuncture treatment ended, was analysed between groups A and C. | Posted | Mean | Standard Deviation | score on a scale | Week 24 |
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| Secondary | WOMAC Functional Disability in Week 24 | Western Ontario and McMaster University Osteoarthritis (WOMAC) functional disability subscale, separated from the WOMAC index, evaluates knee OA functional disability by participants' estimation. It comprises 17 items of functional disability assessment by a 5-point Likert scale ranging from minimal 0 to maximal 68 points. A bigger score presents a worse outcome, and a lower score relates to a better result. WOMAC functional disability measures climbing, rising from a chair/bed, standing, bending, walking, getting in/out of a car/bath/toilet, shopping, putting on socks, sitting, and difficulties in domestic duties. | WOMAC functional disability in Week 24 estimates the effects of acupuncture on functional disability nine weeks after the acupuncture treatment of knee OA ended, using a between-groups A and C analysis. | Posted | Mean | Standard Deviation | score on a scale | Week 24 |
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| Secondary | VAS in Week 24 | Visual Analogue Scale (VAS) assesses knee OA pain intensity, ranging from 0 to 100; the lower value represents a better outcome, and the higher a worse outcome. | VAS in Week 24 estimates the treatment effect of acupuncture on knee pain, 9 weeks after acupuncture treatment ended, in between groups. | Posted | Mean | Standard Deviation | score on a scale | Week 24 |
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| Secondary | KDSQ in Week 24 | The Kidney Deficiency Syndrome Questionnaire (KDSQ) assesses the intensity of kidney deficiency symptoms; the minimum value is 0, and the maximum is 69. A lower score/value represents a better outcome, and a higher score/value represents a worse outcome. This measure represents the effect of acupuncture treatment on Kidney deficiency (KD). | KDSQ in Week 24 estimates the treatment effect of acupuncture on KD symptoms 9 weeks after acupuncture treatment ended, analysed between groups. | Posted | Mean | Standard Deviation | score on a scale | Week 24 |
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| Secondary | DRUG in Week 24 | DRUG is a measure that represents analgesics taken by participants, including various non-steroid anti-inflammatory drugs (NSAIDS) and/or tramadol. Recorded analgesics' doses from the last three days before assessment were recalculated in the comparable dose of the selective representative (ibuprofen) and converted into equivalent dose of milligrams of ibuprofen-ibuprofen equivalent units (IBU). DRUG's units of measure are IBU (units) on the scale ranging from 0 IBU to 4.500 IBU. DRUG decreasement represents a better therapeutic outcome, and an increase in DRUG represents a worse therapeutic outcome. All participants could self-manage the dosage according to their pain. | DRUG in Week 24 estimates the treatment effect of acupuncture on knee OA pain nine weeks after the end of acupuncture treatment, analysed between groups A and C. | Posted | Mean | Standard Deviation | milligrams-equivalent of ibuprofen(IBU) | Week 24 |
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| Secondary | Active Extension L and R Knee in Week 24 | The active extension of the left (L) and right (R) knees in Week 15 is an objective measure taken by an independent physiatrist with a goniometer, expressed on a scale with degrees of a goniometer angle as units. Knee active extension ranges between 0 and 5 degrees: the higher scores represent knee laxity/instability, and the negative scores represent knee flexion contraction. The higher values represent worse outcomes, and the lower values represent better outcomes. | Active extension of L and R knee in Week 24 represents the treatment effect of acupuncture on the knee OA, nine weeks after the acupuncture treatment ended, compared between groups A and C. | Posted | Mean | Standard Deviation | degrees of a goniometer angle | Week 24 |
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| Secondary | Active Flexion L and R Knees in Week 24 | Active flexion of left (L) and right (R) knees in Week 15 is an objective measure provided by an independent physiatrist with a goniometer, expressed on a scale with degrees of a goniometer angle (units). Knee active flexion ranges from 0 to a maximum of 135 degrees; the lower score/value represents a worse outcome, and the higher score/value a better one. | Active flexion of L and R knees in Week 24 represents the treatment effect of acupuncture on knee function nine weeks after acupuncture treatment ended, compared between groups. | Posted | Mean | Standard Deviation | degrees of a goniometer angle | Week 24 |
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| Secondary | Circumference of L and R Upper Leg in Week 24 | Circumference of the left (L) and right (R) upper leg in Week 24 is an objective measure, assessed by an independent physiatrist, at the thigh 15 centimetres above the patellar superior margin, measured with a tape measure. The unit of measure is a centimetre (unit) on the measuring tape (scale) with a range from 0 to 100 centimetres. This measure represents a measure of muscular strength or atrophy. Higher values indicate better outcomes from higher muscular volume, and decreased values indicate worse outcomes from weaker muscular volume. | Circumference of L and R upper leg in Week 24 estimates the treatment effect of acupuncture on knee OA, nine weeks after the acupuncture treatment ended, analysed between groups. | Posted | Mean | Standard Deviation | centimeters | Week 24 |
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| Secondary | Circumference of L and R Knee in Week 24 | Circumference of the left (L) and right (R) upper leg in Week 24 is an objective measure, assessed by an independent physiatrist, at the thigh 15 centimetres above the patellar superior margin, measured with a tape measure. The unit of measure is a centimetre (unit) on the measuring tape (scale) with a range from 0 to 100 centimetres. This measure represents a measure of muscular strength or atrophy. Higher values indicate better outcomes from higher muscular volume, and decreased values indicate worse outcomes from weaker muscular volume. | Circumference of L and R Knee in Week 24 estimates the direct treatment effect of acupuncture on knee osteoarthritis, nine weeks after acupuncture treatment ended, analysed between groups. | Posted | Mean | Standard Deviation | centimeters | Week 24 |
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| Secondary | WOMAC Total in Week 39 | Western Ontario and McMaster University Osteoarthritis (WOMAC) total at the Added assessment at Week 39 in the crossover part compared to pre-experimental baseline value. The total score is a sum of all three subscales: pain, stiffness, and functional limitation. The minimum value is 0, and the maximum value is 96, where the lower score/value represents a better outcome, and a higher score/value represents a worse outcome. | WOMAC total in Week 39 represents the treatment effect of acupuncture on knee pain, stiffness, and function at the added assessment in Week 39 in the A and C groups compared to their baseline values by within-group analysis. It presents two: the magnitude of persisted effects 24 weeks after acupuncture treatment ended in group A, and the immediate effects of acupuncture treatment in group C in comparison with their baseline values. | Posted | Mean | Standard Deviation | score on a scale | Week 39 |
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| Secondary | WOMAC Pain in Week 39 | The Western Ontario and McMaster University Osteoarthritis (WOMAC) pain subscale, selected from the WOMAC index, evaluates knee OA pain by participants. It comprises 5 questions for pain assessed by a 5-point Likert scale, ranging from minimal 0 to maximal 20 points. A bigger score presents a worse outcome, and a lower score relates to a better one. | WOMAC pain subscale in Week 39 by within-group analysis presented the magnitude of persisted pain reduction in group A (24 weeks after acupuncture treatment ended), and in group C, the immediate effects, when group C received acupuncture treatments after crossover in Week 25. | Posted | Mean | Standard Deviation | score on a scale | Week 39 |
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| Secondary | WOMAC Stiffness in Week 39 | Western Ontario and McMaster University Osteoarthritis (WOMAC) stiffness subscale, separated from the WOMAC index, evaluates knee OA stiffness by participants. It comprises 2 questions for stiffness assessed by a 5-point Likert scale ranging from minimal 0 to maximal 8 points. A bigger score represents a worse outcome, and a lower score relates to a better result. WOMAC stiffness measures the stiffness of the knees. | WOMAC stiffness in Week 39 presents in group A the magnitude of persisted acupuncture effects 24 weeks after acupuncture treatment ended, and in group C, the immediate effects of acupuncture after group C crossed over in Week 25, analysed within-groups. | Posted | Mean | Standard Deviation | score on a scale | Week 39 |
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| Secondary | WOMAC Functional Disability in Week 39 | Western Ontario and McMaster University Osteoarthritis (WOMAC) functional disability subscale, separated from the WOMAC index, evaluates knee OA functional disability by participants' estimation. It comprises 17 items for functional disability assessment by a 5-point Likert scale ranging from minimal 0 to maximal 68 points. A bigger score presents a worse outcome, and a lower score relates to a better result. WOMAC functional disability measures climbing, rising from a chair/bed, standing, bending, walking, getting in/out of a car/bath/toilet, shopping, putting on socks, sitting and difficulties in domestic duties. | WOMAC functional disability in Week 39 represents the treatment effect of acupuncture on knee functional disability at the added assessment in Week 39 in the A and C groups compared to their baseline values by within-group analysis. It presents two: the magnitude of persisted effects 24 weeks after acupuncture treatment ended in group A, and the immediate effects of acupuncture treatment in group C in comparison with their baseline values. | Posted | Mean | Standard Deviation | score on a scale | Week 39 |
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| Secondary | VAS in Week 39 | Visual Analogue Scale (VAS) assesses knee OA pain intensity, ranging from 0 to 100; the lower value represents a better outcome, and the higher a worse outcome. This measure estimates the treatment effect of acupuncture on knee pain in Week 39 separately for groups A and C. | VAS in Week 39 presented two: group A was analysed for the magnitude of the persisted acupuncture effects 24 weeks after acupuncture ended, and the immediate acupuncture effect on knee pain was presented in group C. | Posted | Mean | Standard Deviation | score on a scale | Week 39 |
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| Secondary | KDSQ in Week 39 | The Kidney Deficiency Syndrome Questionnaire (KDSQ) assesses the intensity of Kidney deficiency symptoms; the minimum value is 0, and the maximum is 69. A lower score/value represents a better outcome, and a higher score/value represents a worse outcome. This outcome represents the treatment effect of acupuncture on Kidney deficiency symptoms for both groups separately. | KDSQ in Week 39 represents the treatment effect of acupuncture on Kidney deficiency symptoms intensity at the completed acupuncture treatments time point in group C and the magnitude of persisted effects 24 weeks after acupuncture treatments ended in group A, compared with Week 0 by within-group analysis separately for both groups. | Posted | Mean | Standard Deviation | score on a scale | Week 39 |
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| Secondary | DRUG by Added Assessment in Week 39, Crossover Part | DRUG is a measure that represents analgesics taken by participants, including various non-steroid anti-inflammatory drugs (NSAIDS) and/or tramadol. Recorded analgesics' doses from the last three days before assessment were recalculated in the comparable dose of the selective representative (ibuprofen) and converted into equivalent dose of milligrams of ibuprofen-ibuprofen equivalent units (IBU). DRUG's units of measure are IBU (units) on the scale ranging from 0 IBU to 4.500 IBU. DRUG decreasement represents a better therapeutic outcome, and an increase in DRUG represents a worse therapeutic outcome. All participants could self-manage the dosage according to their pain. | DRUG in Week 39 estimates the treatment effect of acupuncture on knee OA pain at the end of acupuncture treatment, analysed within groups A and C to present the effects of the 24-week period after acupuncture ended in group A, and the immediate effects in group C. | Posted | Mean | Standard Deviation | milligrams-equivalent of ibuprofen(IBU) | Week 39 |
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| Secondary | Lequesne Index in Week 24, Between-group Analysis | The Lequesne index is an algofunctional index of knee osteoarthritis that comprises three sections. Its score ranges from a minimal 0 (no pain and disability) to 24 (the greatest pain and disability). This index is added to the study in Week 24 as an additional objective measure. It measures pain severity with 5 questions, walking distance with 2 questions, and activities of daily living with 4 questions. | Groups A and C were compared in Week 24 using a between-groups analysis to assess the effect of the acupuncture treatment on Group A, as Group C served as the control up to Week 24. | Posted | Mean | Standard Deviation | score on a scale | Week 24 |
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| 0 |
| 32 |
| 0 |
| 32 |
| 2 |
| 32 |
| EG001 | Control Group | 32 randomised participants allocated to the Control group got their standard conventional treatment (analgesics) whose dose varied according to the participant's symptoms intensity. Both participants and investigator were not blinded by treatment type. Assessors were blinded to the fact to which group participants belong. Conventional Medical Treatment: Participants took prescribed standard conventional medical treatment for pain or analgesics. Analgesics therapy was prescribed by their general practitioner. Participants modified the dose of analgesics according to the intensity of their symptoms. | 0 | 32 | 0 | 32 | 1 | 32 |
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| hematoma subcutaneus | Injury, poisoning and procedural complications | ICD 10 | Non-systematic Assessment | in the suprapubic region, subcutaneous bleeding happened with induration 4 cm in diameter, the change subsided in 10 days, directly related to pricking the skin with a needle |
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| hematoma of upper leg | Injury, poisoning and procedural complications | ICD 10 | Non-systematic Assessment | bruising suprapatellar 3-4 cm in diameter happened, was resolved in a 7 days |
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Not provided
Not provided
Not provided
| D012216 |
| Rheumatic Diseases |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Superiority |
| Superiority |
| Active extension of the right (R) knees in Week 15 in the between-group analysis. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments. | Wilcoxon (Mann-Whitney) | 0.69654 | Mean Difference (Final Values) | -0.107 | 2-Sided | mean (A group R knee in Week 15) - mean (C group R knee in Week 15) | Superiority |
| Right (R) knee flexion between groups in Week 15. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups regarding specified variables to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments. | Wilcoxon (Mann-Whitney) | 0.517 | Mean Difference (Final Values) | 4.7 | 2-Sided | mean (active flexion R knee of group A at Week 15) - mean (active flexion R knee of group C at Week 15) | Superiority |
| Superiority |
| Circumference of the right (R) upper leg between groups analysis at Week 15. For group normality statistics, the Shapiro-Wilk test (S-W) was used. Furthermore, the comparability of groups regarding specified variables to accept or reject the hypothesis of equality was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data at specified assessments. | Wilcoxon (Mann-Whitney) | 0.084 | Mean Difference (Final Values) | 3.0 | 2-Sided | mean (circumference of R upper leg of group A at Week 15) - mean (circumference of R upper leg of group C at Week 15) | Superiority |
| Superiority |
| Circumference of the right (R) knee in between groups at Week 15. The Shapiro-Wilk test (S-W) was used to test the data distribution's normality. The comparability of groups to accept or reject the null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and standard deviation (SD) were calculated to present the statistical dispersion of sample data at specified assessments. | Wilcoxon (Mann-Whitney) | 0.317 | Mean Difference (Final Values) | 1.3 | 2-Sided | mean (circumference of R knee of group A at Week 15) - mean (circumference of R knee of group C at Week 15) | Superiority |
| Superiority |
| Superiority |
| Right (R) knee analysis between groups at Week 24. For group normality statistics, the Shapiro-Wilk test (S-W) was used. Furthermore, the comparability of groups regarding specified variables to accept or reject the hypothesis of comparability between groups was tested by the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data at specified assessment. | Mean Difference (Final Values) | 0.0 | 2-Sided | mean (Act ext R knee of A group in Week 24) - mean (Act ext R knee of C group in Week 24) | Superiority |
| Superiority |
| Right (R) knee flexion between groups at Week 24. The Shapiro-Wilk test (S-W) tests the normality of the distribution. Furthermore, the comparability of groups regarding specified variables to accept or reject the null hypothesis of comparability was tested with the Mann-Whitney U test, with 95% power and a level of significance α = 0,05. Standard deviation (SD) was calculated to present the statistical dispersion of sample data at an assessment. | Wilcoxon (Mann-Whitney) | 0.491 | Mean Difference (Final Values) | 1.8 | 2-Sided | mean (R knee act flexion of group A in Week 24) - mean (R knee act flexion of group C in Week 24) | Superiority |
| Superiority |
| Circumference of the R upper leg between groups at Week 24. The Shapiro-Wilk test (S-W) was used to test the normality of distribution. The comparability of groups regarding specified variables (null hypothesis) was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range (IQR) and SD were analysed to present the statistical dispersion of sample data at assessments. | Wilcoxon (Mann-Whitney) | 0.273 | Mean Difference (Final Values) | 2.1 | 2-Sided | mean (circumference of R upper leg of group A in Week 24) - mean (circumference of R upper leg of group C in Week 24) | Superiority |
| Circumference of right (R) knees at Week 24 was analysed between groups. The Shapiro-Wilk test (S-W) tests normality distribution. The comparability of groups regarding specified variables to accept or reject the null hypothesis of similarity was tested with the Mann-Whitney U test with 95% power and a level of significance α = 0,05. Standard deviation was calculated to present the statistical dispersion of sample data at assessments. | Wilcoxon (Mann-Whitney) | 0.260 | Mean Difference (Final Values) | 1.6 | 2-Sided | mean (circumference of R knees in Week 24 of group A) - mean (circumference of R knees in Week 24 of group C) | Superiority |
| Superiority |
| WOMAC total of group C in Week 39 was tested for the significance level and mean difference by within-group analysis. The Shapiro-Wilk test (S-W) tests normality distribution. WOMAC total at Week 0 (pre-experimental baseline assessment) and Week 39 were compared to test the null hypothesis of group comparability by the Mann-Whitney U test with 95 % power and a level of significance α=0,05. Standard deviation (SD) was calculated to present the statistical dispersion of a sample. | Wilcoxon (Mann-Whitney) | < 0.001 | Mean Difference (Final Values) | -39.1 | 2-Sided | mean (WOMAC total in Week 39 of group C) - mean (WOMAC total in Week 0 of group C). | Superiority |
| Superiority |
| The pain subscale of the WOMAC index of group C in Week 39 (end of acupuncture of group C) was compared with the pre-experimental baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range and standard deviation were calculated to present the statistical dispersion of data. | Wilcoxon (Mann-Whitney) | <0.001 | Mean Difference (Final Values) | -7.0 | 2-Sided | mean (WOMAC pain in Week 39 of group C) - mean (WOMAC pain in Week 0 of group C) | Superiority |
| Superiority |
| The stiffness subscale of the WOMAC index of group C in Week 39 (end of acupuncture of group C) was compared with the pre-experimental baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α = 0,05. Interquartile range and standard deviation were calculated to present the statistical dispersion of data. | Wilcoxon (Mann-Whitney) | <0.001 | Mean Difference (Final Values) | -3.0 | 2-Sided | mean (WOMAC stiffness in Week 39 of group C) - mean (WOMAC stiffness in Week 0 of group C) | Superiority |
| Superiority |
| The functional disability subscale of the WOMAC index of group C in Week 39 (when acupuncture of group A ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data. | Wilcoxon (Mann-Whitney) | <0.001 | Mean Difference (Final Values) | -29.6 | 2-Sided | mean (WOMAC functional disability in Week 39 of group C) - mean (WOMAC functional disability in Week 0 of group C) | Superiority |
| VAS of group C in Week 39 (when acupuncture of group C ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data. | Wilcoxon (Mann-Whitney) | < 0.001 | Mean Difference (Final Values) | -31.1 | 2-Sided | mean (VAS in Week 39 of group C) - mean (VAS in Week 0 of group C) | Superiority |
| KDSQ of group C in Week 39 (when acupuncture of group C ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data. | Wilcoxon (Mann-Whitney) | <0.001 | Mean Difference (Final Values) | -11.4 | 2-Sided | mean (KDSQ in Week 39 of group C) - mean (KDSQ in Week 0 of group C) | Superiority |
| The DRUG of group C in Week 39 (when acupuncture of group C ended) was compared with baseline values by within-group analysis. The Shapiro-Wilk test (S-W) was used for testing the normality of the distribution. The null hypothesis of groups' similarity was tested with the Mann-Whitney U test, with 95% power and a significance level α=0,05. Interquartile range and SD were calculated to present the statistical dispersion of the data. | Wilcoxon (Mann-Whitney) | 0.134 | Mean Difference (Final Values) | -305.4 | 2-Sided | mean (DRUG in Week 39 of group C) - mean (DRUG in Week 0 of group C) | Superiority |
| Superiority |