NCT04210921

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Beijing Hospital of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Temporomandibular Disorders

Interventions

Type	Name	Description
DEVICE	Acupuncture	The acupuncture will be penetrated in an appropriate angle into a depth of 10-15 mm. Acupuncture manually manipulated by lifting, thrusting, and twirling methods to produce a characteristic sensation known as "De Qi" .
DEVICE	The park sham needle	When the blunt needle goes through the adhesive and contact with skin, it will move back into the hollow centre of the handle rather than penetrate into skin.

Timeline

• Start date: 2019-04-01
• Primary completion: 2020-06-30
• Completion: 2020-06-30
• First posted: 2019-12-26
• Last updated: 2019-12-26

Locations

1 site across 1 country: China