Back to resultsEffects of Soft Tissue Mobilization of Neck Muscles in Individuals With Myogenous Temporomandibular Disorders: Muscle Energy Technique and Strain-counterstrain
Primary Purpose
Myogenous Temporomandibular Disorders (mTMD)
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Muscle energy technique (MET)
Strain-counterstrain (SCS)
sham SCS
Sponsored by
About this trial
This is an interventional treatment trial for Myogenous Temporomandibular Disorders (mTMD) focused on measuring myogenous temporomandibular disorders, neck pain, muscle energy technique, strain-counterstrain, head-neck posture
Eligibility Criteria
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
Sites / Locations
- Yang-Hua, Lin
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Sham Comparator
Arm Label
Muscle energy technique group
Strain-counterstrain group
Control group
Arm Description
Use one of the muscle energy technique methods -- postisometric relaxation technique(PIR) as the intervention method.
Use the Strain-counterstrain technique as the intervention method.
Use the modified Strain-counterstrain technique as the intervention method.
Outcomes
Primary Outcome Measures
Pain intensity in neck and masticatory muscles
ask participants the self-report pain intensity with the NPRS scale
Tenderness sensitivity in neck and masticatory muscles
measure the pressure pain threshold with digital pressure algometer
Secondary Outcome Measures
Maximal mouth-opening
measure the maximal pain free mouth-opening distance
Chewing endurance
test for 5 minutes with chewing gum in the affected site
Head-neck-shoulder posture
measure the Head tilt angle(HTA), Craniovertebral angle(CVA) & Forward shoulder angle (FSA) by Photography in sagittal plane
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04704102
Brief Title
Effects of Soft Tissue Mobilization of Neck Muscles in Individuals With Myogenous Temporomandibular Disorders: Muscle Energy Technique and Strain-counterstrain
Official Title
Effects of Soft Tissue Mobilization of Neck Muscles in Individuals With Myogenous Temporomandibular Disorders: Muscle Energy Technique and Strain-counterstrain
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 11, 2021 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung University
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myogenous Temporomandibular Disorders (mTMD)
Keywords
myogenous temporomandibular disorders, neck pain, muscle energy technique, strain-counterstrain, head-neck posture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Include elements of both longitudinal (three groups) and cross-sectional (four-weeks intervention) research designs
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Muscle energy technique group
Arm Type
Experimental
Arm Description
Use one of the muscle energy technique methods -- postisometric relaxation technique(PIR) as the intervention method.
Arm Title
Strain-counterstrain group
Arm Type
Experimental
Arm Description
Use the Strain-counterstrain technique as the intervention method.
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Use the modified Strain-counterstrain technique as the intervention method.
Intervention Type
Behavioral
Intervention Name(s)
Muscle energy technique (MET)
Intervention Description
A manual therapy technique that uses the gentle muscle contractions of the patient to relax and lengthen muscles and normalize joint motion.
Intervention Type
Behavioral
Intervention Name(s)
Strain-counterstrain (SCS)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
sham SCS
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain intensity in neck and masticatory muscles
Description
ask participants the self-report pain intensity with the NPRS scale
Time Frame
4 weeks
Title
Tenderness sensitivity in neck and masticatory muscles
Description
measure the pressure pain threshold with digital pressure algometer
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Maximal mouth-opening
Description
measure the maximal pain free mouth-opening distance
Time Frame
4 weeks
Title
Chewing endurance
Description
test for 5 minutes with chewing gum in the affected site
Time Frame
4 weeks
Title
Head-neck-shoulder posture
Description
measure the Head tilt angle(HTA), Craniovertebral angle(CVA) & Forward shoulder angle (FSA) by Photography in sagittal plane
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Yang-Hua, Lin
City
Taoyuan
ZIP/Postal Code
33302
Country
Taiwan
12. IPD Sharing Statement
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Effects of Soft Tissue Mobilization of Neck Muscles in Individuals With Myogenous Temporomandibular Disorders: Muscle Energy Technique and Strain-counterstrain
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