Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT04704102
Status:
COMPLETED
Last Update Posted:
2021-08-06
First Post:
2021-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Soft Tissue Mobilization of Neck Muscles in Individuals With Myogenous Temporomandibular Disorders: Muscle Energy Technique and Strain-counterstrain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Include elements of both longitudinal (three groups) and cross-sectional (four-weeks intervention) research designs'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-30', 'studyFirstSubmitDate': '2021-01-08', 'studyFirstSubmitQcDate': '2021-01-08', 'lastUpdatePostDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity in neck and masticatory muscles', 'timeFrame': '4 weeks', 'description': 'ask participants the self-report pain intensity with the NPRS scale'}, {'measure': 'Tenderness sensitivity in neck and masticatory muscles', 'timeFrame': '4 weeks', 'description': 'measure the pressure pain threshold with digital pressure algometer'}], 'secondaryOutcomes': [{'measure': 'Maximal mouth-opening', 'timeFrame': '4 weeks', 'description': 'measure the maximal pain free mouth-opening distance'}, {'measure': 'Chewing endurance', 'timeFrame': '4 weeks', 'description': 'test for 5 minutes with chewing gum in the affected site'}, {'measure': 'Head-neck-shoulder posture', 'timeFrame': '4 weeks', 'description': 'measure the Head tilt angle(HTA), Craniovertebral angle(CVA) \\& Forward shoulder angle (FSA) by Photography in sagittal plane'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['myogenous temporomandibular disorders, neck pain, muscle energy technique, strain-counterstrain, head-neck posture'], 'conditions': ['Myogenous Temporomandibular Disorders (mTMD)']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 20\\~65\n* Self-report neck pain ≥3 months (pain occurs between superior nuchal line and 1st level of thoracic spine)\n* At least one tender point at both Upper trapezius and Sternocleidomastoid muscles\n* Diagnosed as mTMD according to the Diagnostic Criteria for Temporomandibular Disorders(DC/TMD)\n\nExclusion Criteria:\n\n* Cognitive deficit\n* Malignancy, infection, cervical or orthognathic surgery, acute pain, and history of trauma in craniocervical region\n* Neurological problem or cervical radiculopathy/myelopathy\n* Cervical instability with positive rotational alar ligament stress test and transverse ligament stress test, jaw dislocation\n* Tooth implantation or extraction a week before study\n* Vertebrobasilar insufficiency'}, 'identificationModule': {'nctId': 'NCT04704102', 'briefTitle': 'Effects of Soft Tissue Mobilization of Neck Muscles in Individuals With Myogenous Temporomandibular Disorders: Muscle Energy Technique and Strain-counterstrain', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung University'}, 'officialTitle': 'Effects of Soft Tissue Mobilization of Neck Muscles in Individuals With Myogenous Temporomandibular Disorders: Muscle Energy Technique and Strain-counterstrain', 'orgStudyIdInfo': {'id': '2010280044'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Muscle energy technique group', 'description': 'Use one of the muscle energy technique methods -- postisometric relaxation technique(PIR) as the intervention method.', 'interventionNames': ['Behavioral: Muscle energy technique (MET)']}, {'type': 'EXPERIMENTAL', 'label': 'Strain-counterstrain group', 'description': 'Use the Strain-counterstrain technique as the intervention method.', 'interventionNames': ['Behavioral: Strain-counterstrain (SCS)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control group', 'description': 'Use the modified Strain-counterstrain technique as the intervention method.', 'interventionNames': ['Behavioral: sham SCS']}], 'interventions': [{'name': 'Muscle energy technique (MET)', 'type': 'BEHAVIORAL', 'description': 'A manual therapy technique that uses the gentle muscle contractions of the patient to relax and lengthen muscles and normalize joint motion.', 'armGroupLabels': ['Muscle energy technique group']}, {'name': 'Strain-counterstrain (SCS)', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['Strain-counterstrain group']}, {'name': 'sham SCS', 'type': 'BEHAVIORAL', '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', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33302', 'city': 'Taoyuan District', 'country': 'Taiwan', 'facility': 'Yang-Hua, Lin', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Lin Yang-Hua', 'investigatorAffiliation': 'Chang Gung University'}}}}