Ignite Creation Date:
2025-12-24 @ 7:15 PM
Ignite Modification Date:
2026-02-19 @ 7:06 AM
Study NCT ID:
NCT03722303
Status:
SUSPENDED
Last Update Posted:
2025-09-29
First Post:
2018-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lipografting Versus Steroid Injections for Treatment of Carpal Tunnel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}, {'id': 'D006987', 'term': 'Hypesthesia'}, {'id': 'D010292', 'term': 'Paresthesia'}], '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'}, {'id': 'D020886', 'term': 'Somatosensory Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018955', 'term': 'CD36 Antigens'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D003348', 'term': 'Cortisone'}], 'ancestors': [{'id': 'D010980', 'term': 'Platelet Membrane Glycoproteins'}, {'id': 'D008562', 'term': 'Membrane Glycoproteins'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D050612', 'term': 'Fatty Acid Transport Proteins'}, {'id': 'D026901', 'term': 'Membrane Transport Proteins'}, {'id': 'D002352', 'term': 'Carrier Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D011971', 'term': 'Receptors, Immunologic'}, {'id': 'D051122', 'term': 'Scavenger Receptors, Class B'}, {'id': 'D051116', 'term': 'Receptors, Scavenger'}, {'id': 'D011973', 'term': 'Receptors, LDL'}, {'id': 'D018110', 'term': 'Receptors, Lipoprotein'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D015065', 'term': '17-Hydroxycorticosteroids'}, {'id': 'D006889', 'term': 'Hydroxycorticosteroids'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'whyStopped': 'lack of funding', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2016-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-26', 'studyFirstSubmitDate': '2018-10-25', 'studyFirstSubmitQcDate': '2018-10-25', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional Outcome Score', 'timeFrame': 'Up to 1 year post-treatment', 'description': 'This score will be determined by Quick-Disabilities of the Arm, Shoulder and Hand (QuickDASH), which is a validated tool/survey for measuring upper extremity disability. The QuickDASH is scored in two components: the disability/symptom section (11 items, scored 1-5) and the optional high performance sport/music or work modules (4 items, scored 1-5). These raw scores are used to calculate a score out of 100, with a higher score indicating greater disability.'}], 'secondaryOutcomes': [{'measure': 'Score on the Michigan Hand Questionnaire (MHQ)', 'timeFrame': 'Up to 1 year post-treatment', 'description': 'The MHQ is hand-specific outcomes instrument that measures outcomes of patients with conditions of, or injury to, the hand or wrist. In the pain scale, high scores indicate greater pain, while in the other five scales, high scores denote better hand performance.'}, {'measure': "Score on the Brigham Women's Carpal Tunnel Questionnaire", 'timeFrame': 'Up to 1 year post-treatment', 'description': "Brigham Women's Carpal Tunnel Questionnaire is a validated tool for measuring severity of symptoms for carpal tunnel syndrome. The questionnaire is self-administered, with each item scored from 1 to 5 (where 1 indicates no symptoms or no functional difficulty, and 5 indicates maximum symptoms or an inability to perform the functional task)."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['carpal', 'tunnel', 'injection', 'steroid', 'lipografting', 'numbness', 'tingling', 'median nerve'], 'conditions': ['Carpal Tunnel Syndrome']}, 'referencesModule': {'references': [{'pmid': '21524035', 'type': 'BACKGROUND', 'citation': 'LeBlanc KE, Cestia W. Carpal tunnel syndrome. Am Fam Physician. 2011 Apr 15;83(8):952-8.'}, {'pmid': '17443508', 'type': 'BACKGROUND', 'citation': 'Marshall S, Tardif G, Ashworth N. Local corticosteroid injection for carpal tunnel syndrome. Cochrane Database Syst Rev. 2007 Apr 18;2007(2):CD001554. doi: 10.1002/14651858.CD001554.pub2.'}, {'pmid': '19346997', 'type': 'BACKGROUND', 'citation': 'Gutowski KA; ASPS Fat Graft Task Force. Current applications and safety of autologous fat grafts: a report of the ASPS fat graft task force. Plast Reconstr Surg. 2009 Jul;124(1):272-280. doi: 10.1097/PRS.0b013e3181a09506.'}, {'pmid': '22470412', 'type': 'BACKGROUND', 'citation': 'Ibrahim I, Khan WS, Goddard N, Smitham P. Carpal tunnel syndrome: a review of the recent literature. Open Orthop J. 2012;6:69-76. doi: 10.2174/1874325001206010069. Epub 2012 Feb 23.'}]}, 'descriptionModule': {'briefSummary': 'This study applies the regenerative properties of autologous fat transfer to treat mild to moderate carpal tunnel syndrome in comparison to the current standard of care, corticosteroid treatment. The investigators hypothesize the fat transfer would prevent scar formation and aid in nerve excursion along the canal (while the neoangiogenic and regenerative growth factors could stimulate nerve regeneration) better than the standard of care treatment.', 'detailedDescription': 'Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy affecting up to 13% of Americans; CTS is caused by compression of the median nerve in the carpal tunnel leading to nerve ischemia and symptoms of numbness, pain, and tingling. Treatment options depend on the severity of symptoms and range from noninvasive options (most commonly, steroid injections) to definitive surgical release of the compressed median nerve. Both non-invasive techniques and surgical intervention have their shortcomings; thus a novel approach for CTS treatment may be indicated.\n\nLipografting is an established, validated, and widely used technique of plastic surgeons that injects autologous fat to correct contour deformities. From observing these reconstructions, plastic surgeons have witnessed the regenerative properties of fat transfer, specifically delaying the affects of chronic radio-dermatitis. These clinical manifestations have fostered numerous studies defining fat as a rich source of pluripotent stem cells with the potential for reducing scar formation, bringing neo-angiogenesis, and providing a barrier against scar adhesions This study applies the regenerative properties of autologous fat transfer to treat mild to moderate carpal tunnel syndrome in comparison to the current standard of care, corticosteroid treatment. Ideally, the fat transfer would prevent scar formation and aid in nerve excursion along the canal, while the neoangiogenic and regenerative growth factors could stimulate nerve regeneration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primary mild to moderate carpal tunnel syndrome (CTS)\n* report symptoms longer than 6 months\n* night pain\n* weakness\n* sensory deficits\n* fluent English-speaking adult (\\>18)\n\nExclusion Criteria:\n\n* \\<18 years old\n* Non-english speaking\n* injection in past 6 months\n* previous hand surgery\n* previous hand trauma (fracture or dislocation)'}, 'identificationModule': {'nctId': 'NCT03722303', 'briefTitle': 'Lipografting Versus Steroid Injections for Treatment of Carpal Tunnel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Lipografting Versus Steroid Injections for Treatment of Primary Mild to Moderate Carpal Tunnel Syndrome', 'orgStudyIdInfo': {'id': 'AAAK4700'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Steroid Injection', 'description': 'Subjects with CTS will receive steroid injection.', 'interventionNames': ['Drug: Steroid Injection']}, {'type': 'EXPERIMENTAL', 'label': 'Fat Injection', 'description': 'Subjects with CTS will receive fat injection.', 'interventionNames': ['Other: Fat Injection']}], 'interventions': [{'name': 'Fat Injection', 'type': 'OTHER', 'otherNames': ['Fat Transfer'], 'description': 'Used by plastic surgeons, lipografting injects autologous fat to correct contour deformities. Plastic surgeons have witnessed the regenerative properties of fat transfer, and these clinical manifestations have fostered numerous studies defining fat as a rich source of pluripotent stem cells with the potential for reducing scar formation, bringing neo-angiogenesis, and providing a barrier against scar adhesions. This study applies the regenerative properties of autologous fat transfer to treat mild to moderate carpal tunnel syndrome in comparison to the current standard of care, corticosteroid treatment. Ideally, fat transfer would prevent scar formation and aid in nerve excursion along the canal, while the neoangiogenic and regenerative growth factors stimulate nerve regeneration.', 'armGroupLabels': ['Fat Injection']}, {'name': 'Steroid Injection', 'type': 'DRUG', 'otherNames': ['Cortisone Injection'], 'description': 'Standard of care non-operative treatment for the treatment of Carpal Tunnel Syndrome', 'armGroupLabels': ['Steroid Injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Irving Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Melvin P Rosenwasser, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Orthopaedic Surgery at Columbia University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Orthopaedic Scientific Research Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}