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The aim of this pilot study is to compare the effectiveness of electroacupuncture or transcutaneous electrical nerve stimulation in reducing the tenderness in the patients with rheumatoid arthritis. The study adopted a pragmatic, randomized, patient-centered approach to investigate the effectiveness of clinical symptoms and quality of life.
A total of 80 volunteers of patients with rheumatoid arthritis will be recruited from the Chinese medicine or Western medicine clinics in China Medical University Hospital and Dalin Tzu-Chi Hospital. These patients will be randomized to receive electroacupuncture (40 participants) or transcutaneous electrical nerve stimulation (40 participants) treatment two sessions per week and for 10 treatments in total.
The investigators expect that electroacupuncture or transcutaneous electrical nerve stimulation can reduce the severity of pain in the patients with rheumatoid arthritis. The effectiveness of electroacupuncture or transcutaneous electrical nerve stimulation can be detected by visual analogue scale, simplified disease activity index, and disease activity score and be used to improve the clinical symptoms and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| electroacupuncture | Experimental | The needles remained in situ for 30 minutes, during which time the acupuncturist returned to stimulate the needles once to re-elicit the de qi sensation. Participants have 2 sessions per week, with total 5 weeks and 10 sessions. The body points included LI4, LI11, SP6 and ST36. The individual specific points protocol are as follows: GB20, TE5, SP10, GB34, LV3, ba xie, ba fen, Ashi). The acupuncture protocol consists of the body points and some of the individual specific points depending on subjects' condition. |
|
| Transcutaneous electrical nerve stimulation | Experimental | The protocol consisted of first swabbing all points with alcohol, then pads of TENS were sticked on the proper location of acupoints included LI4, LI11, SP6 and ST36. Electrical output of one channel was administered to the surface of body via a combination of two pads. LI4 and LI11, ST36 and SP6 are combination of acupoints, respectively. Participants had 2 sessions per week, with total 5 weeks and 10 sessions. Each session lasted 30 minutes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| electroacupuncture | Device | Electroacupuncture used to reduce the inflammation was proved previously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Morning stiffness(scoring range 0~10 and lasting time : min/day) | Changes from baseline to end of intervention and 4 weeks after intervention completed | baseline, week 5, and week 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Simplified disease activity index (scoring range 0.0 ~ 86.0) | Changes from baseline to end of intervention and 4 weeks after intervention completed | baseline, week 5, and week 9 |
| Disease Activity Score 28 (scoring range 0.0 ~ 9.4) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hung-Rong Yen, M.D. Ph.D. | Contact | 886-4-22052121 | 7508 | hungrongyen@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hung-Rong Yen, M.D. Ph.D. | China Medical University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Medical University Hospital | Recruiting | Taichung | 404 | Taiwan |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D015671 | Electroacupuncture |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
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| TENS | Device | Patients who unlike needles would like to choose TENS as treatment for pain relief. |
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Changes from baseline to end of intervention and 4 weeks after intervention completed
| baseline, week 5, and week 9 |
| Erythrocyte sedimentation rate | Changes from baseline to end of intervention and 4 weeks after intervention completed | baseline, week 5, and week 9 |
| Clinical Disease Activity Index (scoring range 0.0 ~ 76.0) | Changes from baseline to end of intervention and 4 weeks after intervention completed | baseline, week 5, and week 9 |
| Pain Visual Analogue Scale (scoring range 0 ~ 10) | Changes from baseline to end of intervention and 4 weeks after intervention completed | baseline, week 5, and week 9 |
| C-reactive protein | Changes from baseline to end of intervention and 4 weeks after intervention completed | baseline, week 5, and week 9 |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D004599 |
| Electric Stimulation Therapy |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000758 | Anesthesia |