Clinical Efficacy of Acupuncture in the Treatment of Temporomandibular Disorders (TMD)
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2019
CompletedFirst Submitted
Initial submission to the registry
November 8, 2019
CompletedFirst Posted
Study publicly available on registry
December 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedDecember 26, 2019
December 1, 2019
1.2 years
November 8, 2019
December 24, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Visual analogue scale(VAS)
VAS is an international scale which reflects pain intensity and it has a 10-cm line ranging from 0 cm (no pain at all) to 10 cm (extremely painful). Pain intensity or pain relief in the tempormandibular joints will be measured by VAS. And then the investigators will compare the change of different time frames.The total score of this index is 10, and the better effect with the lower score.
Baseline,Week- 4(treatment period) and Week-8(follow-up period)
Secondary Outcomes (6)
Graded Chronic Pain Scale Version 2.0(GCPS 2.0)
Baseline,Week- 4(treatment period) and Week-8(follow-up period)
Jaw Functional Limitations Scale - 20-item (JFLS-20)
Baseline,Week- 4(treatment period) and Week-8(follow-up period)
Depression, Anxiety and Stress Scales (DASS-21)
Baseline,Week- 4(treatment period) and Week-8(follow-up period)
Pittsburgh sleep quality index (PSQI)
Baseline,Week- 4(treatment period) and Week-8(follow-up period)
Pressure Pain Threshold (PPT)
Baseline and Week- 4(treatment period)
- +1 more secondary outcomes
Study Arms (2)
Treatment group
EXPERIMENTALIn the treatment group, the Park needle with a real 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" (feeling of needle sensation refers to tenseness around the needle felt by the practitioner and numbness, distension, soreness, and heaviness around the point felt by the patient), and needles will be stimulated manually at least 10 s, then the needles will be retained for 30 minutes.
Control group
PLACEBO COMPARATORIn the control group, the Park sham needle will instead of the real needle. It is retractile and adopts the sleeve type blunt needle design. 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. The sham needle may be manipulated by lifting, thrusting or twirling as the real one, but it will not insert into the skin authentically.
Interventions
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" .
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.
Eligibility Criteria
You may qualify if:
- Pain disorders in accordance with Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
- 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.
- Cooperated in completing the clinical trial successfully without language and mental disorders.
You may not qualify if:
- Conditions that result in regional pain in temporomandibular joint.
- Autoimmune diseases that result in regional pain in the temporomandibular joint.
- Mental illness or substance abuse.
- Pregnant women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Hospital of Traditional Chinese Medicine affiliated to the Capital Medical University
Beijing, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Acupuncture director
Study Record Dates
First Submitted
November 8, 2019
First Posted
December 26, 2019
Study Start
April 1, 2019
Primary Completion
June 30, 2020
Study Completion
June 30, 2020
Last Updated
December 26, 2019
Record last verified: 2019-12