- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04704102
Effects of Soft Tissue Mobilization of Neck Muscles in Individuals With Myogenous Temporomandibular Disorders: Muscle Energy Technique and Strain-counterstrain
July 30, 2021 updated by: Lin Yang-Hua, Chang Gung University
This is a prospective case series study.There were 20 individuals with chronic neck pain accompanied by myogenous temporomandibular disorders(mTMD) from Linkou and Taoyuan Chang Gung hospitals, and Chang-Gung university.
The purpose of this study was, first, to investigate the effects of muscle energy technique (MET) or strain-counterstrain (SCS) applied on the tender or trigger points of neck muscles on improving pain and pressure pain sensitivity in neck and masticatory muscles, the maximal mouth-opening range of motion, chewing endurance, and head-neck-shoulder posture in patients with chronic neck pain accompanied by mTMD.
Second, whether the significant effects could be reached within the four-week intervention duration.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taoyuan, Taiwan, 33302
- Yang-Hua, Lin
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged 20~65
- Self-report neck pain ≥3 months (pain occurs between superior nuchal line and 1st level of thoracic spine)
- At least one tender point at both Upper trapezius and Sternocleidomastoid muscles
- Diagnosed as mTMD according to the Diagnostic Criteria for Temporomandibular Disorders(DC/TMD)
Exclusion Criteria:
- Cognitive deficit
- Malignancy, infection, cervical or orthognathic surgery, acute pain, and history of trauma in craniocervical region
- Neurological problem or cervical radiculopathy/myelopathy
- Cervical instability with positive rotational alar ligament stress test and transverse ligament stress test, jaw dislocation
- Tooth implantation or extraction a week before study
- Vertebrobasilar insufficiency
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Muscle energy technique group
Use one of the muscle energy technique methods -- postisometric relaxation technique(PIR) as the intervention method.
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A manual therapy technique that uses the gentle muscle contractions of the patient to relax and lengthen muscles and normalize joint motion.
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EXPERIMENTAL: Strain-counterstrain group
Use the Strain-counterstrain technique as the intervention method.
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It's also called the "positional release technique", a manual therapy technique that passively positions the hypertonic (spasmed) muscles and dysfunctional joints in positions of shortened or comfort.
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SHAM_COMPARATOR: Control group
Use the modified Strain-counterstrain technique as the intervention method.
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SCS intervention that position with opposite site limb and direction, and with modified method as consider the easiness of a practitioner to press the tender points
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain intensity in neck and masticatory muscles
Time Frame: 4 weeks
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ask participants the self-report pain intensity with the NPRS scale
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4 weeks
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Tenderness sensitivity in neck and masticatory muscles
Time Frame: 4 weeks
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measure the pressure pain threshold with digital pressure algometer
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4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximal mouth-opening
Time Frame: 4 weeks
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measure the maximal pain free mouth-opening distance
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4 weeks
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Chewing endurance
Time Frame: 4 weeks
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test for 5 minutes with chewing gum in the affected site
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4 weeks
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Head-neck-shoulder posture
Time Frame: 4 weeks
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measure the Head tilt angle(HTA), Craniovertebral angle(CVA) & Forward shoulder angle (FSA) by Photography in sagittal plane
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4 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 11, 2021
Primary Completion (ACTUAL)
June 30, 2021
Study Completion (ACTUAL)
June 30, 2021
Study Registration Dates
First Submitted
January 8, 2021
First Submitted That Met QC Criteria
January 8, 2021
First Posted (ACTUAL)
January 11, 2021
Study Record Updates
Last Update Posted (ACTUAL)
August 6, 2021
Last Update Submitted That Met QC Criteria
July 30, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010280044
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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