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Given the lack of studies in the literature associating the use of acupuncture and sliding suction cup in patients with advanced knee osteoarthritis, the objective of this study is to evaluate the benefits of this association in patients of the Institute of Orthopedics and Traumatology outpatient clinic of the University of São Paulo while awaiting surgical treatment of knee osteoarthritis as a method of pain relief, limb function improvement and quality of life.
120 patients with indications for surgical knee treatment from IOT-HCFMUSP will be invited to participate in the project. Inclusion applications and those who agree to sign a free and informed consent form (IC) will be included.
During the period of inclusion of patients, will be clarified regarding the application and evaluation methods that will be used through consultation and initial medical evaluation. Then, the included patients are randomized into four existing groups:
Group A - Acupuncture Sham + Cupping Sham; Group B - Sham Acupuncture + Real Cupping; Group C - Real Acupuncture + Sham Cupping; Group D - Real Acupuncture + Real Cupping.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A- Placebo | Sham Comparator | Sham Acupuncture and Sham Cupping |
|
| B -Cupping | Active Comparator | Sham Acupuncture and Real Cupping |
|
| C - Acupuncture | Active Comparator | Real Acupuncture and Sham Cupping |
|
| D - Acupuncture + Cupping | Active Comparator | Real Acupuncture and Real Cupping |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Procedure | 20 min of Acupuncture section follow by 10 min of cupping around the knee |
|
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC - Pain | Western Ontario and McMaster Universities Osteoarthritis Womac-Pain section. Score: 0 (no pain) to 20 (worse condition) | value collected at 5 week |
| VAS | Intensity of pain 0-100 mm (0 corresponds to a better condition, otherwise, 100 correspond to a worst condition of pain) | Value collected at 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Analgesic Consumption | number of pills per day For each group, those who had a reduction in the use of pain medications (analgesics and/or anti-inflammatory drugs) we described as Y (yes), and those who maintained or even increased the amount or simply did not return such information we described as N (no). | Number of Participants with reduction in the use of pain medications after protocol (at 5 week) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chin Lin | University of Sao Paulo General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USaoPauloGH | São Paulo | São Paulo | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25865392 | Background | Kraus VB, Blanco FJ, Englund M, Karsdal MA, Lohmander LS. Call for standardized definitions of osteoarthritis and risk stratification for clinical trials and clinical use. Osteoarthritis Cartilage. 2015 Aug;23(8):1233-41. doi: 10.1016/j.joca.2015.03.036. Epub 2015 Apr 9. | |
| 23973143 | Result | Corbett MS, Rice SJ, Madurasinghe V, Slack R, Fayter DA, Harden M, Sutton AJ, Macpherson H, Woolacott NF. Acupuncture and other physical treatments for the relief of pain due to osteoarthritis of the knee: network meta-analysis. Osteoarthritis Cartilage. 2013 Sep;21(9):1290-8. doi: 10.1016/j.joca.2013.05.007. |
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these data are totally confidencial and unique to this protocol
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by phone we applied the WOMAC-Pain and invite who have 15 points or more
recruitment by phone from a list of patients with advanced KOA who is waiting for a TKR. the inclusion criteria is applied.
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| ID | Title | Description |
|---|---|---|
| FG000 | A- Acupuncture Sham + Cupping Sham | Sham acupuncture: Placement of placebo "dagger" needles. The needle tip, when touching the patient's skin, retracts into itself without puncturing the skin. Application locations: LI11, SP9, SP10, LR8, GB34, ST34, Ex-LE5. Running time of 20 minutes. Sham cupping: after each acupuncture session (Sham or True), the respective needles were removed, and acrylic suction cups were placed over the region where the needles were, attached to a strip (micropore) without exerting any negative pressure or movement. Application time of 10 minutes. |
| FG001 | B -Sham Acupuncture + Real Cupping | Acupuncture 20 min of Acupuncture section follow by 10 min of cupping around the knee |
| FG002 | C - Real Acupuncture + Sham Cupping | 20 min of Acupuncture section follow by 10 min of cupping around the knee |
| FG003 | D - Real Acupuncture + Real Cupping | 20 min of Acupuncture section follow by 10 min of cupping around the knee |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | A- Placebo | Sham Acupuncture and Sham Cupping 20 min of Acupuncture section using placebo needle follow by 10 min of cupping sham (no negative pressure) around the knee |
| BG001 | B -Cupping |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| 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 - Pain | Western Ontario and McMaster Universities Osteoarthritis Womac-Pain section. Score: 0 (no pain) to 20 (worse condition) | We used the concept of Intent to Treat (ITT) for statistical analysis purposes, that is, all recruited participants, even if they did not complete the proposed 10-session treatment, were included in the final analysis | Posted | Mean | Standard Deviation | units on a scale | value collected at 5 week |
|
after 5 weeks from initial treatment
no serious adverse event, only local hematoma
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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 | Group A | Sham + Sham | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hematoma | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andre Wan Wen Tsai | USaoPauloGH | 5511981456449 | tsai.andre@gmail.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 | Jan 18, 2017 | Jan 4, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 18, 2017 | Jan 4, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 6, 2017 | Jan 4, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D059350 | Chronic Pain |
| D010003 | Osteoarthritis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D000079742 | Cupping Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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|
Sham Acupuncture and Real Cupping
20 min of Acupuncture section using placebo needle follow by 10 min of real cupping around the knee
| BG002 | C - Acupuncture | Real Acupuncture and Sham Cupping 20 min of Real Acupuncture section follow by 10 min of sham cupping around the knee |
| BG003 | D - Acupuncture + Cupping | Real Acupuncture and Real Cupping 20 min of Real Acupuncture section follow by 10 min of real cupping around the knee |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| WOMAC-Pain | range 0-20, 0 correspond to a better condition, otherwise, 20 correspond to a worst condition of pain | Mean | Standard Deviation | units on a scale |
|
| VAS | range 0-100, 0 correspond to a better condition, otherwise 100 correspond to a worst condition of pain | Mean | Standard Deviation | units on a scale |
|
| OG002 |
| Group C |
Real Acupuncture + Sham Cupping |
| OG003 | Group D | Real Acupuncture + Real Cupping |
|
|
| Primary | VAS | Intensity of pain 0-100 mm (0 corresponds to a better condition, otherwise, 100 correspond to a worst condition of pain) | We used the concept of Intent to Treat (ITT) for statistical analysis purposes, that is, all recruited participants, even if they did not complete the proposed 10-session treatment, were included in the final analysis. | Posted | Mean | Standard Deviation | units on a scale | Value collected at 5 weeks |
|
|
|
| Secondary | Analgesic Consumption | number of pills per day For each group, those who had a reduction in the use of pain medications (analgesics and/or anti-inflammatory drugs) we described as Y (yes), and those who maintained or even increased the amount or simply did not return such information we described as N (no). | We used the concept of Intent to Treat (ITT) for statistical analysis purposes, that is, all recruited participants, even if they did not complete the proposed 10-session treatment, were included in the final analysis. | Posted | Count of Participants | Participants | Number of Participants with reduction in the use of pain medications after protocol (at 5 week) |
|
|
|
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Group B | Sham Acp + Real Cupping | 0 | 30 | 0 | 30 | 1 | 30 |
| EG002 | Group C | Real ACP + Sham Cupping | 0 | 30 | 0 | 30 | 2 | 30 |
| EG003 | Group D | Real + Real | 0 | 30 | 0 | 30 | 2 | 30 |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Male |
|