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

Primary Purpose

Temporomandibular Disorders

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Acupuncture
The park sham needle
Sponsored by
Beijing Hospital of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Disorders

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Pittsburgh sleep quality index (PSQI)
The total score of this scale is 21. The better the sleep quality with the lower score.
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.
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).

Full Information

First Posted
November 8, 2019
Last Updated
December 24, 2019
Sponsor
Beijing Hospital of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04210921
Brief Title
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

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Hospital of Traditional Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Acupuncture
Intervention Description
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" .
Intervention Type
Device
Intervention Name(s)
The park sham needle
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual analogue scale(VAS)
Description
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.
Time Frame
Baseline,Week- 4(treatment period) and Week-8(follow-up period)
Secondary Outcome Measure Information:
Title
Graded Chronic Pain Scale Version 2.0(GCPS 2.0)
Description
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.
Time Frame
Baseline,Week- 4(treatment period) and Week-8(follow-up period)
Title
Jaw Functional Limitations Scale - 20-item (JFLS-20)
Description
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.
Time Frame
Baseline,Week- 4(treatment period) and Week-8(follow-up period)
Title
Depression, Anxiety and Stress Scales (DASS-21)
Description
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.
Time Frame
Baseline,Week- 4(treatment period) and Week-8(follow-up period)
Title
Pittsburgh sleep quality index (PSQI)
Description
The total score of this scale is 21. The better the sleep quality with the lower score.
Time Frame
Baseline,Week- 4(treatment period) and Week-8(follow-up period)
Title
Pressure Pain Threshold (PPT)
Description
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.
Time Frame
Baseline and Week- 4(treatment period)
Title
Surface electromyogram(sEMG)
Description
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).
Time Frame
Baseline and Week- 4(treatment period)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bin Li Dr
Phone
0086-18910781852
Email
libin@bjzhongyi.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lu Liu Dr
Phone
0086-13520788752
Email
liu_lu1985@aliyun.com
Facility Information:
Facility Name
Beijing Hospital of Traditional Chinese Medicine affiliated to the Capital Medical University
City
Beijing
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

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

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