Comparing electroacupuncture and TENS for rheumatoid arthritis pain relief
Comparative Effectiveness Research of Electroacupuncture and Transcutaneous Electrical Nerve Stimulation in Patients With Rheumatoid Arthritis: A Pragmatic Randomized Clinical Trial
This study is testing whether electroacupuncture or TENS can better relieve pain and improve quality of life for people with rheumatoid arthritis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 20 Years to 70 Years |
| Sex | All |
| Sponsor | China Medical University Hospital Academic / other |
| Locations | 1 site (Taichung) |
| Trial ID | NCT04521998 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to compare the effectiveness of electroacupuncture and transcutaneous electrical nerve stimulation (TENS) in reducing tenderness and improving quality of life in patients with rheumatoid arthritis. A total of 80 participants will be recruited and randomly assigned to receive either electroacupuncture or TENS, with both groups undergoing treatment twice a week for a total of 10 sessions. The study will assess pain severity and clinical symptoms using various scales to determine which intervention is more effective.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20-70 who meet the American College of Rheumatology criteria for rheumatoid arthritis and are on a stable medication regimen.
Not a fit: Patients currently treated with biological agents or those with certain medical conditions, such as uncontrolled blood pressure or bleeding disorders, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with effective non-pharmacological options for managing pain associated with rheumatoid arthritis.
How similar studies have performed: Previous studies have shown promising results for both electroacupuncture and TENS in managing pain, suggesting that this comparative approach could yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Taichung
- China Medical University Hospital — Taichung, Taiwan (Recruiting)
Study contacts
- Principal investigator: Hung-Rong Yen, M.D. Ph.D. — China Medical University Hospital
- Study coordinator: Hung-Rong Yen, M.D. Ph.D.
- Email: hungrongyen@gmail.com
- Phone: 886-4-22052121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.