Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-03-05 @ 4:32 AM
Study NCT ID:
NCT06209918
Status:
RECRUITING
Last Update Posted:
2024-01-18
First Post:
2023-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Bioptron Light on Carpal Tunnel Syndrome(BLCTS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}], 'ancestors': [{'id': 'D020423', 'term': 'Median Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D012090', 'term': 'Cumulative Trauma Disorders'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 62}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-17', 'studyFirstSubmitDate': '2023-07-21', 'studyFirstSubmitQcDate': '2024-01-17', 'lastUpdatePostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Boston carpal tunnel questionnaire', 'timeFrame': '4 weeks', 'description': 'Assess Symptom severity and functional capacity'}], 'primaryOutcomes': [{'measure': 'Nerve conduction studies (NCS)', 'timeFrame': '4 weeks', 'description': 'assess sensory and motor nerve conduction velocity,gf and sensory nerve action potential'}], 'secondaryOutcomes': [{'measure': 'Visual analogue scale', 'timeFrame': '4 weeks', 'description': 'assess pain intensity'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bioptron light therapy', 'Phototherapy', 'Carpal tunnel syndrome'], 'conditions': ['Carpal Tunnel Syndrome Pregnancy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effect of bioptron light therapy on pregnancy related carpal tunnel syndrome', 'detailedDescription': 'Carpal tunnel syndrome (CTS) is a symptomatic compression neuropathy of the median nerve at the level of the wrist, characterized by hand pain, numbness, and tingling in the distribution of the median nerve (thumb, index, middle finger, and the radial side of the ring finger) and a reduction in grip strength and hand function. The severity of symptoms can be clinically categorized into mild, moderate, and severe Bioptron phototherapy acts as a "sterile" trigger on human in vitro isolated peripheral blood mononuclear cells (PBMCs), affecting their cytokine production and driving the immune response towards an anti-inflammatory/reparative profile and representing a non-pharmaceutical and non-invasive option for several clinical conditionsA randomized control study, the women will be randomly assigned into two groups, (31 women for each group) equal in number. Group (A) will include 31 women will receive Bioptron light combined with advice and patient education (10 minutes per session, 3 sessions per week, for 4 weeks). Group (B) will be receiving advice only for same duration as group (A)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '25 Years', 'genderBased': True, 'genderDescription': 'pregnant women having carpal tunnel syndrome', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant females clinically daignosed with carpal tunnel syndrome at least 1 month\n* age will range from (25-35) years.\n* body mass index (BMI) will be (BMI ≤ 35 kg/m2)\n\nExclusion Criteria:\n\n* history of neurologic disease\n* hand surgery\n* hand trauma,\n* diabetes mellitus\n* cervical spondylosis\n* osteoarthritis of cervical spine and wrist joint\n* chronic renal failure\n* heart failure\n* connective tissue disorders'}, 'identificationModule': {'nctId': 'NCT06209918', 'briefTitle': 'Effect of Bioptron Light on Carpal Tunnel Syndrome(BLCTS)', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Bioptron Light Therapy on Pregnancy Related Carpal Tunnel Syndrome', 'orgStudyIdInfo': {'id': 'P.T.REC/012/003875'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group that recieve bioptron light and advice and patient education', 'description': 'patients will recieve bioptron light therapy for 10 minutes per session, 3 sessions per week, for 4 weeks.', 'interventionNames': ['Device: bioptron light therapy']}, {'type': 'OTHER', 'label': 'control group that recieve advice and patient education and wrist brace', 'description': 'will keep the wrist in a neutral position, not bent back or bent down too far', 'interventionNames': ['Device: wrist brace']}], 'interventions': [{'name': 'bioptron light therapy', 'type': 'DEVICE', 'description': 'patient will be sitting on comfortable chair with the hand placed on an armrest in an extended and supinated position. Firstly, the skin over the wrist area will be exposed and cleaned by alcohol to achieve maximal penetration of light. Then, the bioptron device will be held perpendicular to the surface of the treated area, at a distance of 10 cm.', 'armGroupLabels': ['group that recieve bioptron light and advice and patient education']}, {'name': 'wrist brace', 'type': 'DEVICE', 'description': 'will keep the wrist in a neutral position, not bent back or bent down too far', 'armGroupLabels': ['control group that recieve advice and patient education and wrist brace']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Sara Ma Ahmed, lecturer', 'role': 'CONTACT', 'email': 'saramagdy87@cu.edu.eg', 'phone': '01063998331'}], 'facility': 'Sara Magdy Ahmed', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'Sara Ma Ahmed, lecturer', 'role': 'CONTACT', 'email': 'saramagdy87@cu.edu.eg', 'phone': '01063998331'}], 'overallOfficials': [{'name': 'Sara Ma Ahmed, lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Sara Magdy Ahmed', 'investigatorAffiliation': 'Cairo University'}}}}