Comparative Effectiveness Research of Electroacupuncture and TENS in Patients With Rheumatoid Arthritis
NCT ID: NCT04521998
Last Updated: 2022-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2020-08-04
2025-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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electroacupuncture
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.
electroacupuncture
Electroacupuncture used to reduce the inflammation was proved previously.
Transcutaneous electrical nerve stimulation
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.
TENS
Patients who unlike needles would like to choose TENS as treatment for pain relief.
Interventions
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electroacupuncture
Electroacupuncture used to reduce the inflammation was proved previously.
TENS
Patients who unlike needles would like to choose TENS as treatment for pain relief.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
70 Years
ALL
No
Sponsors
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China Medical University Hospital
OTHER
Responsible Party
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Principal Investigators
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Hung-Rong Yen, M.D. Ph.D.
Role: PRINCIPAL_INVESTIGATOR
China Medical University Hospital
Locations
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China Medical University Hospital
Taichung, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CMUH106-REC1-100
Identifier Type: -
Identifier Source: org_study_id
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