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| Name | Class |
|---|---|
| The Third Affiliated hospital of Zhejiang Chinese Medical University | OTHER |
| Jiaxing TCM Hospital | UNKNOWN |
| Zhejiang Provincial Hospital of TCM | OTHER |
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Knee osteoarthritis (KOA) a chronic disease with symptoms of persistent pain or rest pain , joint stiffness, numbness, limitation of activity and even disability, with significant associated costs and effects on individuals' life quality. Acupuncture as an approach for the management of chronic pain, is receiving increasing recognition from both the public and professionals. The aim of this study is to indicate the effects of three commonly used acupuncture treatments for KOA.
360 subjects with KOA recruited from six centers will be randomized to six groups ,and receive four-week acupuncture, Electro-acupuncture, Moxibustion ,Warm-needling ,sham-needle, celebrex treatment. The primary outcomes are Visual Analogue Scale (VAS) and WOMAC function score.The Secondary outcomes are WOMAC pain score, WOMAC stiffness score,the Physical Activity Scale of the Elderly (PASE),knee joint swelling measurement and WHO-BREF life quality scale.The follow-up period is six months. This study will be a rigorous,randomized, sham and drug controlled trial focusing on using different kinds of acupuncture treatment for treating KOA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture group | Experimental | When recruited from six centers,the participant will be randomized to six groups .In acupuncture group participant will receive four-week acupuncture treatment(three times a week )continuously for 4 weeks,12 treatments in total. The follow-up period is six months. |
|
| Electro-acupuncture group | Experimental | When recruited from six centers,the participant will be randomized to six groups. In this group participant receive four-week electro-acupuncture treatment(three times a week )continuously for 4 weeks,12 treatments in total. The follow-up period is six months. |
|
| Moxibustion group | Experimental | When recruited from six centers,the participant will be randomized to six groups. In this group participant receive four-week moxibustion treatment (three times a week )continuously for 4 weeks,12 treatments in total. The follow-up period is six months. |
|
| Warm-needling group | Experimental | When recruited from six centers,the participant will be randomized to six groups. In this group participant receive four-week warm-needling treatment (three times a week )continuously for 4 weeks,12 treatments in total. The follow-up period is six months. |
|
| Sham-needle group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| treatment1 | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Score change | Intensity of pain range (lately 3 days' average): 0 =no pain to 10 =worst possible pain. Higher score indicating severe pain. | baseline,2 weeks, 4 weeks ,3 months,6months |
| WOMAC function change | The WOMAC function subscale referred to the participant's ability to move around and perform usual activities of daily living. The WOMAC function subscale was comprised of 17 questions regarding the degree of difficulty experienced due to OA in the study knee. The WOMAC function subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse physical function. An overall score range of 0 (minimum) to 68 (maximum), with higher scores indicating worse physical function. | baseline,2 weeks,4 weeks ,3 months,6months |
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC pain change | The WOMAC pain subscale referred to the patient's pain. It was comprised of 5 items, with each item scored from 0 (minimum) to 4 (maximum), where 4 indicated worst pain condition. An overall score range of 0 (minimum) to 20 (maximum), with higher scores indicating worse physical function. | baseline,2 weeks,4weeks ,3 months,6months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianqiao Fang, Ph.D,M.D | Zhejiang CMU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The third affiliated hospital of Zhejiang CMU | Hangzhou | Zhejiang | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18279766 | Background | Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008 Feb;16(2):137-62. doi: 10.1016/j.joca.2007.12.013. | |
| 25784383 |
| Label | URL |
|---|---|
| Related Info | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 23, 2018 | Jun 15, 2018 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 23, 2018 | Jun 15, 2018 | ICF_001.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 |
|---|---|
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Zhejiang Hospital |
| OTHER |
| Red Cross Hospital, Hangzhou, China | OTHER |
| Zhejiang Provincial Tongde Hospital | OTHER |
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| Sham Comparator |
When recruited from six centers,the participant will be randomized to six groups.In this group participant receive four-week sham acupuncture treatment (three times a week )continuously for 4 weeks,12 treatments in total. The follow-up period is six months. |
|
| Celebrex group | Active Comparator | When recruited from six centers,the participant will be randomized to six groups . In this group participant will receive Celebrex (Celebrex, Capsules, Pfizer Pharmaceuticals Ltd)treatment, which will be applied 1 time daily(one time oral 0.2g) for 4 weeks. The follow-up period is six months. |
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| treatment2 | Other |
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| treatment3 | Other |
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| treatment4 | Other |
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| treatment5 | Other |
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| Celebrex | Drug | Drug: Celebrex (Celebrex, Capsules, Pfizer Pharmaceuticals Ltd), which will be applied 1 time daily( taken 0.2g one time orally ) Time of treatment :4 weeks Other Name: celecoxib |
|
| WOMAC stiffness change | The WOMAC stiffness subscale was comprised of 2 questions regarding the degree of stiffness experienced in the study knee. The WOMAC stiffness subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse stiffness. An overall score range of 0 (minimum) to 8 (maximum), with higher scores indicating more stiffness. | baseline,2 weeks,4 weeks ,3 months,6months |
| PASE change | Physical Activity Scale for the Elderly was comprised of 36 questions regarding physical activity of elderly's house hold,leisure,work performance with different score weight.The higher scores indicating better physical activity. | baseline,2 weeks,4 weeks ,3 months,6months |
| Quality of life change | WHO-BREF 36-Item Form assessing quality of life was comprised of 26 items which measured the following broad domains: physical health, psychological health, social relationships, and environment.With higher scores indicating better quality of life. | baseline,2 weeks,4 weeks ,3 months,6months |
| Knee swelling measurement change | 0-3 score indicating swelling and average Knee circumference of three times. | baseline,2 weeks, 4 weeks ,3 months,6months |
| Expectancy questionnaires | Expectancy questionnaires were comprised of two brief items assessing the expectancy of the patients about acupuncture(or/and)moxibustion. | baseline |
| Background |
| Gelber AC. Conventional medical therapy for osteoarthritis: current state of the evidence. Curr Opin Rheumatol. 2015 May;27(3):312-7. doi: 10.1097/BOR.0000000000000164. |
| 24905958 | Result | Holla JF, van der Leeden M, Knol DL, Roorda LD, Hilberdink WK, Lems WF, Steultjens MP, Dekker J. Predictors and outcome of pain-related avoidance of activities in persons with early symptomatic knee osteoarthritis: a five-year followup study. Arthritis Care Res (Hoboken). 2015 Jan;67(1):48-57. doi: 10.1002/acr.22381. |
| 14679827 | Result | WHO Scientific Group on the Burden of Musculoskeletal Conditions at the Start of the New Millennium. The burden of musculoskeletal conditions at the start of the new millennium. World Health Organ Tech Rep Ser. 2003;919:i-x, 1-218, back cover. |
| 19066899 | Result | Xiang YJ, Dai SM. Prevalence of rheumatic diseases and disability in China. Rheumatol Int. 2009 Mar;29(5):481-90. doi: 10.1007/s00296-008-0809-z. Epub 2008 Dec 6. |
| 14710506 | Result | Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bull World Health Organ. 2003;81(9):646-56. Epub 2003 Nov 14. |
| 39961986 | Derived | Sun J, Liang Y, Luo KT, Shao XM, Tu MQ, Wu XT, Liu F, Li XW, Chen YD, Zhang QF, Ji CH, Li RR, Li XY, Xu F, Fang JQ. Efficacy of Different Acupuncture Techniques for Pain and Dysfunction in Patients with Knee Osteoarthritis: A Randomized Controlled Trial. Pain Ther. 2025 Apr;14(2):737-751. doi: 10.1007/s40122-025-00713-x. Epub 2025 Feb 17. |
| 32171318 | Derived | Zhang Q, Fang J, Chen L, Wu J, Ni J, Liu F, Sun J. Different kinds of acupuncture treatments for knee osteoarthritis: a multicentre, randomized controlled trial. Trials. 2020 Mar 14;21(1):264. doi: 10.1186/s13063-019-4034-8. |
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| D012216 |
| Rheumatic Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |