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

Primary Purpose

Arthritis, Rheumatoid

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
electroacupuncture
TENS
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring Comparative effectiveness research, electroacupuncture, transcutaneous electrical nerve stimulation, rheumatoid arthritis:, randomized clinical trial

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • China Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

electroacupuncture

Transcutaneous electrical nerve stimulation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Morning stiffness(scoring range 0~10 and lasting time : min/day)
Changes from baseline to end of intervention and 4 weeks after intervention completed

Secondary Outcome Measures

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

Full Information

First Posted
August 16, 2020
Last Updated
July 18, 2022
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04521998
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 4, 2020 (Actual)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
Keywords
Comparative effectiveness research, electroacupuncture, transcutaneous electrical nerve stimulation, rheumatoid arthritis:, randomized clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
electroacupuncture
Arm Type
Experimental
Arm Description
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.
Arm Title
Transcutaneous electrical nerve stimulation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
electroacupuncture
Intervention Description
Electroacupuncture used to reduce the inflammation was proved previously.
Intervention Type
Device
Intervention Name(s)
TENS
Intervention Description
Patients who unlike needles would like to choose TENS as treatment for pain relief.
Primary Outcome Measure Information:
Title
Morning stiffness(scoring range 0~10 and lasting time : min/day)
Description
Changes from baseline to end of intervention and 4 weeks after intervention completed
Time Frame
baseline, week 5, and week 9
Secondary Outcome Measure Information:
Title
Simplified disease activity index (scoring range 0.0 ~ 86.0)
Description
Changes from baseline to end of intervention and 4 weeks after intervention completed
Time Frame
baseline, week 5, and week 9
Title
Disease Activity Score 28 (scoring range 0.0 ~ 9.4)
Description
Changes from baseline to end of intervention and 4 weeks after intervention completed
Time Frame
baseline, week 5, and week 9
Title
Erythrocyte sedimentation rate
Description
Changes from baseline to end of intervention and 4 weeks after intervention completed
Time Frame
baseline, week 5, and week 9
Title
Clinical Disease Activity Index (scoring range 0.0 ~ 76.0)
Description
Changes from baseline to end of intervention and 4 weeks after intervention completed
Time Frame
baseline, week 5, and week 9
Title
Pain Visual Analogue Scale (scoring range 0 ~ 10)
Description
Changes from baseline to end of intervention and 4 weeks after intervention completed
Time Frame
baseline, week 5, and week 9
Title
C-reactive protein
Description
Changes from baseline to end of intervention and 4 weeks after intervention completed
Time Frame
baseline, week 5, and week 9

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hung-Rong Yen, M.D. Ph.D.
Phone
886-4-22052121
Ext
7508
Email
hungrongyen@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hung-Rong Yen, M.D. Ph.D.
Organizational Affiliation
China Medical University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hung-Rong Yen, M.D., Ph.D.
Phone
886-4-22052121
Ext
7508
Email
hungrongyen@gmail.com
First Name & Middle Initial & Last Name & Degree
Ming-Cheng Huang, M.D.
Phone
886-4-22052121
Ext
1670
Email
mchuang1128@gmail.com
First Name & Middle Initial & Last Name & Degree
Hung-Rong Yen, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Mao-Feng Sun, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Ming-Cheng Huang, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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

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