Comparative Effectiveness Research of Electroacupuncture and TENS in Patients With Rheumatoid Arthritis

NCT ID: NCT04521998

Last Updated: 2022-07-20

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-04

Study Completion Date

2025-09-30

Brief Summary

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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

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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.

Conditions

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Arthritis, Rheumatoid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Group Type EXPERIMENTAL

electroacupuncture

Intervention Type DEVICE

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.

Group Type EXPERIMENTAL

TENS

Intervention Type DEVICE

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.

Intervention Type DEVICE

TENS

Patients who unlike needles would like to choose TENS as treatment for pain relief.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Hung-Rong Yen, M.D. Ph.D.

Role: CONTACT

886-4-22052121 ext. 7508

Facility Contacts

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Hung-Rong Yen, M.D., Ph.D.

Role: primary

886-4-22052121 ext. 7508

Ming-Cheng Huang, M.D.

Role: backup

886-4-22052121 ext. 1670

Other Identifiers

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CMUH106-REC1-100

Identifier Type: -

Identifier Source: org_study_id

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