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

July 18, 2022 updated by: China Medical University Hospital

Comparative Effectiveness Research of Electroacupuncture and Transcutaneous Electrical Nerve Stimulation in Patients With Rheumatoid Arthritis: A Pragmatic Randomized Clinical Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taichung, Taiwan, 404
        • Recruiting
        • China Medical University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hung-Rong Yen, M.D., Ph.D.
        • Sub-Investigator:
          • Mao-Feng Sun, M.D., Ph.D.
        • Sub-Investigator:
          • Ming-Cheng Huang, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: electroacupuncture
Electroacupuncture used to reduce the inflammation was proved previously.
Experimental: 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.
Device: TENS
Patients who unlike needles would like to choose TENS as treatment for pain relief.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morning stiffness(scoring range 0~10 and lasting time : min/day)
Time Frame: baseline, week 5, and week 9
Changes from baseline to end of intervention and 4 weeks after intervention completed
baseline, week 5, and week 9

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Simplified disease activity index (scoring range 0.0 ~ 86.0)
Time Frame: baseline, week 5, and week 9
Changes from baseline to end of intervention and 4 weeks after intervention completed
baseline, week 5, and week 9
Disease Activity Score 28 (scoring range 0.0 ~ 9.4)
Time Frame: baseline, week 5, and week 9
Changes from baseline to end of intervention and 4 weeks after intervention completed
baseline, week 5, and week 9
Erythrocyte sedimentation rate
Time Frame: baseline, week 5, and week 9
Changes from baseline to end of intervention and 4 weeks after intervention completed
baseline, week 5, and week 9
Clinical Disease Activity Index (scoring range 0.0 ~ 76.0)
Time Frame: baseline, week 5, and week 9
Changes from baseline to end of intervention and 4 weeks after intervention completed
baseline, week 5, and week 9
Pain Visual Analogue Scale (scoring range 0 ~ 10)
Time Frame: baseline, week 5, and week 9
Changes from baseline to end of intervention and 4 weeks after intervention completed
baseline, week 5, and week 9
C-reactive protein
Time Frame: baseline, week 5, and week 9
Changes from baseline to end of intervention and 4 weeks after intervention completed
baseline, week 5, and week 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Investigators

  • Principal Investigator: Hung-Rong Yen, M.D. Ph.D., China Medical University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2020

Primary Completion (Anticipated)

September 30, 2025

Study Completion (Anticipated)

September 30, 2025

Study Registration Dates

First Submitted

August 16, 2020

First Submitted That Met QC Criteria

August 19, 2020

First Posted (Actual)

August 21, 2020

Study Record Updates

Last Update Posted (Actual)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUH106-REC1-100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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