Clinical Efficacy of Acupuncture in the Treatment of Temporomandibular Disorders (TMD)

Last updated: December 24, 2019
Sponsor: Beijing Hospital of Traditional Chinese Medicine
Overall Status: Active - Recruiting

Phase

N/A

Condition

Oral Facial Pain

Treatment

N/A

Clinical Study ID

NCT04210921
2018BL-060-01
  • Ages 18-80
  • All Genders

Study Summary

This is a single-blinded, randomized controlled trial to explore the effectiveness of acupuncture in the treatment of the pain due to TMD using the latest diagnostic criteria combined with subjective and objective indexes.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Pain disorders in accordance with Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)

  2. Pain in the jaw, temple, in the ear, in front of ear or headache in the temple at anysides, and pain or headache modified (remission or aggravation) with movement at least 3 months.

  3. Cooperated in completing the clinical trial successfully without language and mentaldisorders.

Exclusion

Exclusion Criteria:

  1. Conditions that result in regional pain in temporomandibular joint.

  2. Autoimmune diseases that result in regional pain in the temporomandibular joint.

  3. Mental illness or substance abuse.

  4. Pregnant women.

Study Design

Total Participants: 60
Study Start date:
April 01, 2019
Estimated Completion Date:
June 30, 2020

Study Description

This is a single-blinded, randomized controlled clinical trial. A total of 60 participants will be randomly assigned to two different groups. The treatment group will receive acupuncture with real penetration of the needle, while participants in the control group will be treated with the Park sham needle. All participants will be given for 4 weeks of treatment and 4 weeks of follow-up.The primary end-point is the reducing in intensity of pain due to TMD, which will be evaluated before treatment, 4 weeks after treatment and follow-up (4 weeks after treatment) by using 0-10 visual analogue score. Secondary end points include Graded Chronic Pain Scale Version 2.0(GCPS 2.0),Jaw Functional Limitations Scale - 20-item (JFLS-20),Depression, Anxiety and Stress Scales (DASS-21),Pittsburgh sleep quality index (PSQI),Pressure Pain Threshold (PPT),Surface electromyogram(sEMG).

Connect with a study center

  • Beijing Hospital of Traditional Chinese Medicine affiliated to the Capital Medical University

    Beijing,
    China

    Active - Recruiting

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