Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-02-20 @ 6:46 PM
Study NCT ID:
NCT02797002
Status:
COMPLETED
Last Update Posted:
2017-10-25
First Post:
2016-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validity of Neck Extensor Muscles Endurance Test in Non-specific Chronic Neck Pain and Asymptomatic Subjects
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012149', 'term': 'Restraint, Physical'}], 'ancestors': [{'id': 'D032763', 'term': 'Behavior Control'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007103', 'term': 'Immobilization'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-24', 'studyFirstSubmitDate': '2016-06-03', 'studyFirstSubmitQcDate': '2016-06-07', 'lastUpdatePostDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Flexor and Extensor cervical muscles holding time (second)', 'timeFrame': '6 months'}, {'measure': 'Anteroposterior diameter of the flexor and extensor cervical muscles (mm)', 'timeFrame': '6 months'}, {'measure': 'Mediolateral diameter of the flexor and extensor cervical muscles (mm)', 'timeFrame': '6 months'}, {'measure': 'Cross section area of the flexor and extensor cervical muscles (cm2)', 'timeFrame': '6 months'}, {'measure': 'Neck disability questionnaire score', 'timeFrame': '6 months'}, {'measure': 'Visual analogue scale score', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Pearson correlation coefficient of the cervical muscles holding time with Anteroposterior and border and cross section area of the flexor and extensor cervical muscles', 'timeFrame': '6 months'}]}, 'conditionsModule': {'conditions': ['Neck Pain']}, 'descriptionModule': {'briefSummary': "Neck pain (NP) is one of the most common and costly musculoskeletal complaints in today's societies. Cervical muscles endurance has been commonly associated with the development of NP. Real-time ultrasound imaging is a reliable and valid technique recently used by physical therapists to evaluate muscle structure, function and activation patterns. The aim of this study is if change in muscle thickness can correlate with the results of the endurance testing."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with and without neck pain', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with neck pain: experiencing pain for at least 3 months in the last year, having pain score of 3 or more on visual analogue scale.\n* Healthy subjects: no history of neck pain\n\nExclusion Criteria:\n\n* History of cervical discopathy\n* Any surgery on neck\n* Traumatic neck injury\n* Any congenital disorders'}, 'identificationModule': {'nctId': 'NCT02797002', 'briefTitle': 'Validity of Neck Extensor Muscles Endurance Test in Non-specific Chronic Neck Pain and Asymptomatic Subjects', 'organization': {'class': 'OTHER', 'fullName': 'University of Social Welfare and Rehabilitation Science'}, 'orgStudyIdInfo': {'id': 'IR.USWR.REC.1394.191'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chronic non specific neck pain', 'description': 'Experiencing neck pain for at least 3 months in the last year', 'interventionNames': ['Other: Assessment']}, {'label': 'Without neck pain (asymptomatic)', 'description': 'No history of neck pain', 'interventionNames': ['Other: Assessment']}], 'interventions': [{'name': 'Assessment', 'type': 'OTHER', 'armGroupLabels': ['Chronic non specific neck pain', 'Without neck pain (asymptomatic)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1985713831', 'city': 'Tehran', 'country': 'Iran', 'facility': 'University of Social Welfare and Rehabilitation Sciences', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Social Welfare and Rehabilitation Science', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Candidate', 'investigatorFullName': 'Dr. L. Ghamkhar', 'investigatorAffiliation': 'University of Social Welfare and Rehabilitation Science'}}}}