Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2026-01-06 @ 9:39 AM
Study NCT ID:
NCT06519058
Status:
COMPLETED
Last Update Posted:
2025-12-17
First Post:
2024-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Self-Myofascial Stretching on Carpal Tunnel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2024-06-27', 'studyFirstSubmitQcDate': '2024-07-19', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Boston Carpal Tunnel Questionnaire', 'timeFrame': '6 weeks', 'description': 'Used to assess the function of carpals'}, {'measure': 'Visual Analogue Scale', 'timeFrame': '6 weeks', 'description': 'Involves asking participants to rate their current level of pain on a scale from 0= No pain to 10= maximum pain is felt.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Patients With Stage I and II Carpal Tunnel Syndrome']}, 'descriptionModule': {'briefSummary': "Background/Objectives: Carpal tunnel syndrome (CTS), a median mononeuropathy from nerve compression in the wrist's carpal tunnel, will be studied to compare self-myofascial carpal ligament stretching plus conventional physical therapy versus physical therapy alone for pain reduction and function improvement in stage I/II CTS patients.\n\nMethods: Thirty-six eligible stage I/II CTS patients will be randomized (18/group). The experimental group will receive self-myofascial stretching + conventional therapy; controls will get conventional therapy only. Treatment will last 6 weeks; outcomes will be assessed via Boston Carpal Tunnel Questionnaire and Visual Analogue Scale."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDiagnosed CTS, stage I/II (EMG-confirmed).\n\nAge 30-60 years.\n\nBoth genders.\n\nDominant hand (unilateral/bilateral).\n\nEnglish literate.\n\nExclusion Criteria:\n\nPolyneuropathy.\n\nAdaptive equipment use.\n\nShoulder pathologies.\n\nOther neurological/musculoskeletal conditions.\n\nRecent carpal tunnel release (\\<1 year).'}, 'identificationModule': {'nctId': 'NCT06519058', 'briefTitle': 'Effectiveness of Self-Myofascial Stretching on Carpal Tunnel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Imam Abdulrahman Bin Faisal University'}, 'officialTitle': 'Effectiveness of Carpal Ligament Self-Myofascial Stretching Over Conventional Physical Therapy on Reducing Pain and Improving Function in Patients With Stage I and II Carpal Tunnel Syndrome', 'orgStudyIdInfo': {'id': '(AWH/EC/01/2022)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'self-myofascial stretching group', 'interventionNames': ['Other: self-myofascial stretching']}, {'type': 'SHAM_COMPARATOR', 'label': 'conventional physical therapy group', 'interventionNames': ['Other: conventional physical therapy']}], 'interventions': [{'name': 'self-myofascial stretching', 'type': 'OTHER', 'description': 'self-myofascial stretching exercise', 'armGroupLabels': ['self-myofascial stretching group']}, {'name': 'conventional physical therapy', 'type': 'OTHER', 'description': 'conventional physical therapy treatment, including exercises', 'armGroupLabels': ['conventional physical therapy group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Calicut', 'country': 'India', 'facility': 'Awh special college', 'geoPoint': {'lat': 11.6, 'lon': 92.73333}}], 'overallOfficials': [{'name': 'Shibili Nuhmani, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imam Abdulrahman Bin Faisal University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imam Abdulrahman Bin Faisal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Shibili Nuhmani', 'investigatorAffiliation': 'Imam Abdulrahman Bin Faisal University'}}}}