Clinical trial NCT04210921: Clinical Efficacy of Acupuncture in the Treatment of Temporomandibular Disorders (TMD)
Official title: Clinical Efficacy of Acupuncture in the Treatment of Temporomandibular Disorders(TMD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Temporomandibular Disorders
Lead sponsor: Beijing Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: 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 any sides, 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 mental disorders.

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.

Primary outcomes:
measure: Visual analogue scale(VAS)
timeFrame: Baseline,Week- 4(treatment period) and Week-8(follow-up period)
Secondary outcomes:
measure: Graded Chronic Pain Scale Version 2.0(GCPS 2.0)
timeFrame: Baseline,Week- 4(treatment period) and Week-8(follow-up period)
measure: Jaw Functional Limitations Scale - 20-item (JFLS-20)
timeFrame: Baseline,Week- 4(treatment period) and Week-8(follow-up period)
measure: Depression, Anxiety and Stress Scales (DASS-21)
timeFrame: Baseline,Week- 4(treatment period) and Week-8(follow-up period)
measure: Pittsburgh sleep quality index (PSQI)
timeFrame: Baseline,Week- 4(treatment period) and Week-8(follow-up period)
measure: Pressure Pain Threshold (PPT)
timeFrame: Baseline and Week- 4(treatment period)
measure: Surface electromyogram(sEMG)
timeFrame: Baseline and Week- 4(treatment period)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital of Traditional Chinese Medicine affiliated to the Capital Medical University
Study officials:
References: