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| Name | Class |
|---|---|
| Beijing Friendship Hospital | OTHER |
| Beijing Jishuitan Hospital | OTHER |
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Knee osteoarthritis (KOA), also called degenerative knee disease, is one of the most common bone and joint diseases in clinic. It often occurs in middle-aged people, especially women. It was estimated to affect more than 9 million individuals in the United States in 2005 and is a leading cause of disability and medical costs. Most elderly people over the age of 65 have radiographic and/or clinical evidence of osteoarthritis. KOA is a lifelong disease which can lead to obvious pain, joint stiffness, limitation of activity and even joint failure or disability.According to the papers published in the past years, we find that acupuncture therapy for the treatment of knee osteoarthritis include manual acupuncture, electro-acupuncture, acupotomy, laser acupuncture, fire needle and so on, among which manual acupuncture and electro-acupuncture are most commonly used.The aim of this study is to compare the effectiveness of electro-acupuncture and manual acupuncture in reducing pain and improving function in patients with KOA.
Participants will be randomly allocated to one of two groups. Those in the first group receive electro-acupuncture, which involves having needles inserted into acupuncture points (locations on the body affected by acupuncture) which are stimulated manually for 10 seconds to create "De Qi" sensation and an electrical apparatus (HANS-200A acupoint nerve stimulator, Nanjing Jisheng Medical Co., Ltd. production, wave of 2/100Hz) was then connected to the needles with alligator clips to stimulate the needles in pairs ST36-SP9/GB34 and ST34-SP10. The stimulus intensity will be increased until the patient reported a strong but comfortable intensity. Those in the second group have the same schedule as the electro-acupuncture group except that the electrical apparatus has working power indicator and sound without actual current output. Both groups will receive 30-minute, 24 sessions intervention over eight weeks. Moreover, a number of questionnaires at the start of the study and then again after 4, 8, 12 and 16 week will be completed by participants.
It is expected that participants will benefit from a decrease in pain and improved function. The risks of participation are minimal. Occasionally, acupuncture can make people feel nauseous or experience a temporary increase in pain either during or after treatment. Rare side effects during acupuncture treatment include fainting, infection and subcutaneous hematoma (pooling of blood under the skin). Participants will be warned of these potential side-effects before consenting to have acupuncture.
Participants will be allowed, or required, to withdraw from the trial based on the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electro-acupuncture group | Experimental | After recruiting, patients are assigned to the electro-acupuncture group by randomization,and then receive electro-acupuncture treatment.Both treatments consist of 24 sessions of 30 minutes duration, administered over 8 weeks (usually three sessions per week). Participants in both groups will be evaluated at baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks. |
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| Manual acupuncture group | Experimental | After recruiting, patients are assigned to the manual acupuncture group by randomization,and then receive manual acupuncture treatment.Both treatments consist of 24 sessions of 30 minutes duration, administered over 8 weeks (usually three sessions per week). Participants in both groups will be evaluated at baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electro-acupuncture | Device | Patients in this group will be treated by use of 6-7 local acupuncture points (ST34, ST35, ST36, EX-LE2, EX-LE5, GB33, GB34, SP9, SP10, LR7, LR8 and Ashi) and 2-3 distal points (GB31, GB36, GB39, GB41, ST40, ST41, LR3, BL60, SP6 and KI3). Needles will be stimulated manually for 10 seconds to achieve "De Qi" sensation and an electrical apparatus (HANS-200A acupoint nerve stimulator, Nanjing Jisheng Medical Co., Ltd. production, wave of 2/100Hz) will be then connected to the needles with alligator clips to stimulate the needles in pairs ST36-SP9/GB34 and ST34-SP10. The stimulus intensity will be increased until the patient reports a strong but comfortable intensity. |
| Measure | Description | Time Frame |
|---|---|---|
| Success Rate | a change of 50% from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, stiffness and function scores at 8 weeks. | baseline, 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pain | using WOMAC pain subscale | baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks |
| Stiffness | using WOMAC stiffness subscale | baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cunzhi Liu, M.D | Contact | 010-52176043 | lcz623780@126.com | |
| Yongting Li, Postgraduate Student | Contact | 15210518799 | liyong_ting@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Cunzhi Liu, M.D | Beijing Hospital of Traditional Chinese Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hostipal of Traditional Chinese Medicine affiliated to Capital medical University | Beijing | Beijing Municipality | 100000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32904642 | Derived | Shi GX, Tu JF, Wang TQ, Yang JW, Wang LQ, Lin LL, Wang Y, Li YT, Liu CZ. Effect of Electro-Acupuncture (EA) and Manual Acupuncture (MA) on Markers of Inflammation in Knee Osteoarthritis. J Pain Res. 2020 Aug 26;13:2171-2179. doi: 10.2147/JPR.S256950. eCollection 2020. | |
| 32022581 | Derived | Wang TQ, Li YT, Wang LQ, Shi GX, Tu JF, Yang JW, Hou YQ, Lin LL, Sun N, Zhao JJ, Hou HK, Liu CZ. Electroacupuncture versus manual acupuncture for knee osteoarthritis: a randomized controlled pilot trial. Acupunct Med. 2020 Oct;38(5):291-300. doi: 10.1177/0964528419900781. Epub 2020 Feb 5. |
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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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| Manual acupuncture | Device | Participants in the group have the same schedule as the electro-acupuncture group except that the electrical apparatus has working power indicator and sound without actual current output. |
|
| Knee-joint function | using WOMAC functional subscale | baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks |
| Quality of life | using the 12-Item Short Form Health Survey (SF-12) | baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks |
| Number of emergency analgesics (Celebrex/Loxonin) used | using Drug Use Form | baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks |
| Inflammatory markers | Luminex liquid chip method (LuminexxMAP, Technology, USA) Bio-plex200 system high throughput analysis platform (Bio-Rad) will be used to detect the expression of free protein in serum. Patients will receive fasting blood samples in the morning and then be centrifuged with 3000r/min, 15min in two hours. | baseline, 8 weeks |
| Credibility/expectancy questionnaires | Credibility/expectancy questionnaires are used to assess the credibility and expectancy of the patients | baseline |
| Adverse events | using Adverse Event Form | up to 16 weeks |
| 30683147 | Derived | Tu JF, Yang JW, Lin LL, Wang TQ, Du YZ, Liu ZS, Hu H, Zhao JJ, Yu XG, Jia CS, Wang J, Wang T, Hou YQ, Zou X, Wang Y, Shao JK, Wang LQ, Yu ZS, Liu CZ. Efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: study protocol for a randomised controlled trial. Trials. 2019 Jan 25;20(1):79. doi: 10.1186/s13063-018-3138-x. |
| D012216 |
| Rheumatic Diseases |