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

Arthritis, Rheumatoid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04521998
• Other study ID #: CMUH106-REC1-100
• Status: Recruiting
• Phase: N/A
• Start date: August 4, 2020
• Est. completion date: September 30, 2025

Study information

• Verified date: July 2022
• Source: China Medical University Hospital
• Contact: Hung-Rong Yen, M.D. Ph.D.
• Phone: 886-4-22052121
• Email: hungrongyen[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

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