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

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

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.

Study Overview

• Status: Unknown
• Conditions: Temporomandibular Disorders
• Intervention / Treatment: Device: Acupuncture; Device: The park sham needle

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).

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bin Li Dr; Phone Number: 0086-18910781852; Email: libin@bjzhongyi.com
• Study Contact Backup: Name: Lu Liu Dr; Phone Number: 0086-13520788752; Email: liu_lu1985@aliyun.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; In 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.	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" .
Placebo Comparator: Control group; In 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Graded Chronic Pain Scale Version 2.0(GCPS 2.0)	This scale includes the description of the degree of pain, a description of function, and a description of the time period of pain, which will provide effective data of the degree of pain within 1 month.The result of the index is divided into 5 grades. The less pain and influence with the lower the grade.	Baseline,Week- 4(treatment period) and Week-8(follow-up period)
Jaw Functional Limitations Scale - 20-item (JFLS-20)	This scale includes the evaluation of mastication limitation, the evaluation of vertical mobility limitation, the evaluation of verbal and nonverbal communication limitation.There are 20 items in this index, with a total score of 200 points. The better the mandibular function with the lower the score.	Baseline,Week- 4(treatment period) and Week-8(follow-up period)
Depression, Anxiety and Stress Scales (DASS-21)	This scale consists of three parts, 21 items in total. The total score of each part is 21 points. Less emotional distress with the lower the score.	Baseline,Week- 4(treatment period) and Week-8(follow-up period)
Pittsburgh sleep quality index (PSQI)	The total score of this scale is 21. The better the sleep quality with the lower score.	Baseline,Week- 4(treatment period) and Week-8(follow-up period)
Pressure Pain Threshold (PPT)	Participants will sit comfortably and relax their muscles during this measurement. A needle will be pressed at a constant speed perpendicular to the skin (0.5kg /cm2/second).The evaluator will be informed as soon as the participants feel pain and then record the results of measurement. The treatment is effective If the participants show elevated PPT after 4 weeks of treatment.	Baseline and Week- 4(treatment period)
Surface electromyogram(sEMG)	The electrodes will be placed parallel to the muscle fibers of the specify what muschemuscle.EMG signal acquisition will be performed in three tasks: mandibular resting position (MR), during maximal voluntary contraction (MVC), and during habitual chewing (HC).	Baseline and Week- 4(treatment period)

Collaborators and Investigators

• Sponsor: Beijing Hospital of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Anticipated): June 30, 2020
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: November 8, 2019
• First Submitted That Met QC Criteria: December 24, 2019
• First Posted (Actual): December 26, 2019

Study Record Updates

• Last Update Posted (Actual): December 26, 2019
• Last Update Submitted That Met QC Criteria: December 24, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
• Other Study ID Numbers: 2018BL-060-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No