Comparative Effectiveness Research of Electroacupuncture and TENS in Patients With Rheumatoid Arthritis
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 4, 2020
CompletedFirst Submitted
Initial submission to the registry
August 16, 2020
CompletedFirst Posted
Study publicly available on registry
August 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2025
CompletedJuly 20, 2022
July 1, 2022
5.2 years
August 16, 2020
July 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (6)
Simplified disease activity index (scoring range 0.0 ~ 86.0)
baseline, week 5, and week 9
Disease Activity Score 28 (scoring range 0.0 ~ 9.4)
baseline, week 5, and week 9
Erythrocyte sedimentation rate
baseline, week 5, and week 9
Clinical Disease Activity Index (scoring range 0.0 ~ 76.0)
baseline, week 5, and week 9
Pain Visual Analogue Scale (scoring range 0 ~ 10)
baseline, week 5, and week 9
- +1 more secondary outcomes
Study Arms (2)
electroacupuncture
EXPERIMENTALThe 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
EXPERIMENTALThe 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.
Interventions
Electroacupuncture used to reduce the inflammation was proved previously.
Patients who unlike needles would like to choose TENS as treatment for pain relief.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China Medical University Hospital
Taichung, 404, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hung-Rong Yen, M.D. Ph.D.
China Medical University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2020
First Posted
August 21, 2020
Study Start
August 4, 2020
Primary Completion
September 30, 2025
Study Completion
September 30, 2025
Last Updated
July 20, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share