Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-25 @ 5:32 PM
Study NCT ID:
NCT05785104
Status:
COMPLETED
Last Update Posted:
2024-03-06
First Post:
2023-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Muscle Energy Technique Versus Myofascial Release on Cervical and Lumbar Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-07-26', 'releaseDate': '2024-07-04'}], 'estimatedResultsFirstSubmitDate': '2024-07-04'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D013001', 'term': 'Somatoform Disorders'}, {'id': 'D019547', 'term': 'Neck Pain'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'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': 'D000089803', 'term': 'Myofascial Release Therapy'}], 'ancestors': [{'id': 'D008405', 'term': 'Massage'}, {'id': 'D064746', 'term': 'Therapy, Soft Tissue'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double masking'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two groups, one group will be treated by muscle energy technique and other will be treated by myofascial release'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-05', 'studyFirstSubmitDate': '2023-03-14', 'studyFirstSubmitQcDate': '2023-03-14', 'lastUpdatePostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fibromyalgia impact questionnaire', 'timeFrame': 'Four weeks', 'description': 'Used to assess health related quality of life before and after the treatment, maximum score means worse outcome'}, {'measure': 'Visual analogue scale', 'timeFrame': 'Four weeks', 'description': 'Used to assess the severity of cervical and lumbar pain of each premenopausal women in both groups before and after the treatment, maximum score means worse outcome'}, {'measure': 'Active range of motion of cervical and lumbar regions', 'timeFrame': 'Four weeks', 'description': 'Measurement of active flexion, extension, lateral flexion in cervical and lumbar regions before and after the treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cervical pain,lumbar pain,fibromyalgia'], 'conditions': ['Lumbar Pain Syndrome', 'Cervical Pain']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to determine the effect of muscle energy technique versus myofascial release on cervical and lumbar pain in premenopausal women with fibromyalgia', 'detailedDescription': 'Fibromyalgia is an idiopathic, non articular pain syndrome with generalized tender points. It is multisystem disease characterized by sleep disturbance and fatigue. It affect 5% of the world population. The incidence is higher in women than in men. And the age is between 30 and 35 years old.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Premenopausal women with fibromyalgia\n* Ages ranges between 30 - 45 years old\n* Body mass index \\< 35 kg/m2\n* All are medically stable\n\nExclusion Criteria:\n\n* specific cervical and lumbar pain\n* Smokers\n* Pregnant women\n* Medically unstable\n* Postmenopausal women'}, 'identificationModule': {'nctId': 'NCT05785104', 'briefTitle': 'Effect of Muscle Energy Technique Versus Myofascial Release on Cervical and Lumbar Pain', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Muscle Energy Technique Versus Myofascial Release on Cervical and Lumbar Pain in Premenopausal Women With Fibromyalgia', 'orgStudyIdInfo': {'id': '012/004046'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Myofascial release', 'description': 'The patients will receive myofascial release technique on cervical and lumbar regions three times per week for four weeks', 'interventionNames': ['Other: Myofascial release']}, {'type': 'EXPERIMENTAL', 'label': 'Muscle energy technique', 'description': 'The patients will receive muscle energy technique for cervical and lumbar regions three times per week for four weeks', 'interventionNames': ['Other: Muscle energy technique']}], 'interventions': [{'name': 'Myofascial release', 'type': 'OTHER', 'description': 'Is Facilitation of mechanical and neurological adaptive capacity as integrated through the Myofascial system', 'armGroupLabels': ['Myofascial release']}, {'name': 'Muscle energy technique', 'type': 'OTHER', 'description': 'Is manual therapy procedure that involves alternating periods of resisted muscle contraction and assisted stretching', 'armGroupLabels': ['Muscle energy technique']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Samar Ahmed Abd El Salam Negm', 'investigatorFullName': 'Samar Ahmed Abd EL Salam Negm', 'investigatorAffiliation': 'Cairo University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-07-04', 'type': 'RELEASE'}, {'date': '2024-07-26', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Samar Ahmed Abd EL Salam Negm, Samar Ahmed Abd El Salam Negm, Cairo University'}}}}