Arthritis, Rheumatoid
Conditions
Keywords
Comparative effectiveness research, electroacupuncture, transcutaneous electrical nerve stimulation, rheumatoid arthritis:, randomized clinical trial
Brief summary
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.
Detailed description
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.
Interventions
DEVICEelectroacupuncture
Electroacupuncture used to reduce the inflammation was proved previously.
DEVICETENS
Patients who unlike needles would like to choose TENS as treatment for pain relief.
Sponsors
China Medical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 20-70 years old * Met the American College of Rheumatology criteria (2010) for RA * Classification of X-ray : Stage I\ III * The participants' RA medication regimen (DMARD, NSAID, steroid)were eligible if they were on a stable dose for at least 3 months before entry into and throughout the study. * All patients were instructed not to make any changes in their background therapies during the study. * Intra-articular or pulse steroid were not permitted during the study
Exclusion criteria
* Be treated with biological agents, such as antagonist of TNF-alpha, IL-6, Jak, and CD20 mono antibody in the last 3 months * Having history of serious drug allergy * Pregnancy or breastfeeding * Bleeding or coagulation disorders * Localized skin infections * Uncontrolled or ill-controlled blood pressure with diastolic pressure≥110 mmHg * Any other acupuncture treatment or herbal medication for RA within 2 weeks before screening * needle phobia * Intra-articular corticosteroid or pulse steroid within 4 weeks preceding the study * Any severe chronic or uncontrolled comorbid disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morning stiffness(scoring range 0~10 and lasting time : min/day) | baseline, week 5, and week 9 | Changes from baseline to end of intervention and 4 weeks after intervention completed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Simplified disease activity index (scoring range 0.0 ~ 86.0) | baseline, week 5, and week 9 | Changes from baseline to end of intervention and 4 weeks after intervention completed |
| Disease Activity Score 28 (scoring range 0.0 ~ 9.4) | baseline, week 5, and week 9 | Changes from baseline to end of intervention and 4 weeks after intervention completed |
| C-reactive protein | baseline, week 5, and week 9 | Changes from baseline to end of intervention and 4 weeks after intervention completed |
| Clinical Disease Activity Index (scoring range 0.0 ~ 76.0) | baseline, week 5, and week 9 | Changes from baseline to end of intervention and 4 weeks after intervention completed |
| Pain Visual Analogue Scale (scoring range 0 ~ 10) | baseline, week 5, and week 9 | Changes from baseline to end of intervention and 4 weeks after intervention completed |
| Erythrocyte sedimentation rate | baseline, week 5, and week 9 | Changes from baseline to end of intervention and 4 weeks after intervention completed |
Countries
Taiwan
Contacts
Primary ContactHung-Rong Yen, M.D. Ph.D.
Outcome results
None listed