Clinical trial NCT04521998: Comparative Effectiveness Research of Electroacupuncture and TENS in Patients With Rheumatoid Arthritis
Official title: Comparative Effectiveness Research of Electroacupuncture and Transcutaneous Electrical Nerve Stimulation in Patients With Rheumatoid Arthritis: A Pragmatic Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arthritis, Rheumatoid
Keywords: Comparative effectiveness research
electroacupuncture
transcutaneous electrical nerve stimulation
rheumatoid arthritis:
randomized clinical trial
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2020-08-21
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Morning stiffness(scoring range 0~10 and lasting time : min/day)
timeFrame: baseline, week 5, and week 9
Secondary outcomes:
measure: Simplified disease activity index (scoring range 0.0 ~ 86.0)
timeFrame: baseline, week 5, and week 9
measure: Disease Activity Score 28 (scoring range 0.0 ~ 9.4)
timeFrame: baseline, week 5, and week 9
measure: Erythrocyte sedimentation rate
timeFrame: baseline, week 5, and week 9
measure: Clinical Disease Activity Index (scoring range 0.0 ~ 76.0)
timeFrame: baseline, week 5, and week 9
measure: Pain Visual Analogue Scale (scoring range 0 ~ 10)
timeFrame: baseline, week 5, and week 9
measure: C-reactive protein
timeFrame: baseline, week 5, and week 9
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University Hospital
name: Hung-Rong Yen, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: