Effect of Transcutaneous Auricular Electroacupuncture on Sleep Disturbances in Patients With Rheumatoid Arthritis: A Randomized Double-Blind Clinical Trial

NARecruitingINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

June 6, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Transcutaneous Electric Nerve StimulationRheumatoid ArthritisSleep Quality
Interventions
DEVICE

Transcutaneous Auricular Vagus Nerve Stimulation

Treatment using the Huatuo electronic acupuncture device (model SDZ-IIB) with electrodes placed on the auricular points related to the heart and kidney. Pulsed wave type is sparse-dense wave, with a frequency of 20Hz and intensity set to the highest level tolerable without pain. Patients will perform self-treatment at home for 30 minutes, twice daily, for 5 days a week over 4 weeks.

DEVICE

Sham Stimulation

Treatment using the same Huatuo electronic acupuncture device with electrodes placed on different ear points (over the ear helix). The device settings (pulse type, frequency, intensity) are the same as the experimental group but do not correspond to traditional acupuncture points. Patients will also perform self-treatment at home as per the same schedule as the experimental group.

Trial Locations (1)

100053

RECRUITING

Guang'anmen Hospital, Beijing

All Listed Sponsors
collaborator

Hebei Provincial Hospital of Traditional Chinese Medicine

OTHER_GOV

collaborator

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

collaborator

Shenzhen Futian Hospital of TCM

OTHER_GOV

collaborator

Inner Mongolia Autonomous Region Hospital of Traditional Chinese Medicine

UNKNOWN

lead

Juan Jiao

OTHER