Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT04791202
Status:
UNKNOWN
Last Update Posted:
2021-03-16
First Post:
2021-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hypertonic Dextrose Versus Corticosteroid Intra-Articular Injections for the Treatment of Trapeziometacarpal Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005947', 'term': 'Glucose'}, {'id': 'D000077555', 'term': 'Methylprednisolone Acetate'}], 'ancestors': [{'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The clinical assessor is blinded to the baseline evaluations and to the administered treatments. Information about the medications used in the study will be given to the participants, but they will be blinded to their group allocation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2022-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-12', 'studyFirstSubmitDate': '2021-03-08', 'studyFirstSubmitQcDate': '2021-03-08', 'lastUpdatePostDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'post-injection pain', 'timeFrame': '1 day', 'description': 'visual analog score for pain (0 for no pain, 10 for worst pain)'}, {'measure': 'post-injection functionality', 'timeFrame': '1 day', 'description': 'Q-DASH score for functionality (0 for no disability, 100 for most disability)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain', 'Satisfaction, Patient', 'Functionality']}, 'referencesModule': {'references': [{'pmid': '18182958', 'type': 'RESULT', 'citation': 'Cook GS, Lalonde DH. MOC-PSSM CME article: Management of thumb carpometacarpal joint arthritis. Plast Reconstr Surg. 2008 Jan;121(1 Suppl):1-9. doi: 10.1097/01.prs.0000294708.70340.8c.'}, {'pmid': '20452743', 'type': 'RESULT', 'citation': 'Merritt MM, Roddey TS, Costello C, Olson S. Diagnostic value of clinical grind test for carpometacarpal osteoarthritis of the thumb. J Hand Ther. 2010 Jul-Sep;23(3):261-7; quiz 268. doi: 10.1016/j.jht.2010.02.001. Epub 2010 May 10.'}, {'pmid': '2712610', 'type': 'RESULT', 'citation': 'van Saase JL, van Romunde LK, Cats A, Vandenbroucke JP, Valkenburg HA. Epidemiology of osteoarthritis: Zoetermeer survey. Comparison of radiological osteoarthritis in a Dutch population with that in 10 other populations. Ann Rheum Dis. 1989 Apr;48(4):271-80. doi: 10.1136/ard.48.4.271.'}]}, 'descriptionModule': {'briefSummary': "The evolving reports form recent studies are creating a promise on the potential use of dextrose injections for treating arthritis and replacing current method of treating early osteoarthritis by corticosteroids by giving long standing effect and improving patients' symptoms and function. Over the past 5 years, an increasing number of level I and level II studies have emerged, examining the effect of intra-articular prolotherapy for the treatment of both hip and knee osteoarthritis. On the contrary, there is limited data in small joints, such as the temporomandibular joint.", 'detailedDescription': "Carpometacarpal osteoarthritis (OA) is a degenerative condition of the hand that causes pain, stiffness and weakness. It is the second most common site of degenerative disease in the hand after arthritis of the distal interphalangeal joints. The prevalence of symptomatic hand OA in people over 70 years of age has been estimated as 13.4 % for men and 26.2 % for women. OA is more frequent in older age groups, leading to considerable disability with a burden on health services and on the economy. Risk factor for carpometacarpal osteoarthritis of the thumb includes being female, middle age, previous trauma, repetitive use and inflammatory joint disease. Lifetime prevalence of this condition approaches 10%.\n\nInjections are a useful conservative treatment modality prior to considering surgical treatment. Corticosteroid injection is helpful in the treatment of the disease, but some patients gain only short-term benefits. Evolving reports are showing promising results for the application of dextrose as an alternative method for the treatment of Carpometacarpal osteoarthritis, based on their induction for growth factors and inflammatory mediators. For instance, prolotherapy has been used as a treatment of musculoskeletal pain with various etiologies. It has been suggested that prolotherapy induces little inflammation and stimulates endogenous repair especially by prompting release of growth factors. Dextrose is an agent commonly used for prolotherapy.\n\nThe evolving reports form recent studies are creating a promise on the potential use of dextrose injections for treating arthritis and replacing current method of treating early OA by corticosteroids by giving long standing effect and improving patients' symptoms and function. Over the past 5 years, an increasing number of level I and level II studies have emerged, examining the effect of intra-articular prolotherapy for the treatment of both hip and knee osteoarthritis. On the contrary, there is limited data in small joints, such as the temporomandibular joint."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Those patients with diagnosis of carpometacarpal (CMC) osteoarthritis\n* Those patients who fit the age limits\n\nExclusion Criteria:\n\n* Those patients outside of the age limits\n* Those patients with systemic rheumatic disease, comorbid hand conditions (such as carpal tunnel syndrome or De Quervain's tenosynovitis), gout, pseudogout\n* Those patients with a predisposition to bleeding issues\n* Those patients with previous surgery to the affected thumb\n* Those patients with previous injection to the involved thumb base within the past 12 months\n* Those patients with severe X-ray osteoarthritis of grade IV (Eaton and Littler classification) and no evidence of CMC joint space narrowing on plain radiographs"}, 'identificationModule': {'nctId': 'NCT04791202', 'briefTitle': 'Hypertonic Dextrose Versus Corticosteroid Intra-Articular Injections for the Treatment of Trapeziometacarpal Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Christine M. Kleinert Institute for Hand and Microsurgery'}, 'officialTitle': 'Hypertonic Dextrose Versus Corticosteroid Intra-Articular Injections for the Treatment of Trapeziometacarpal Arthritis: A Prospective Double-blind Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '20.0174'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dextrose Group', 'description': 'Injection for Group A: A 27-gauge needle to be inserted in the 1st CMC joint, at which time 0.5 ml of 15% dextrose mixed with 0.5 ml of 1% lidocaine solution is injected into intra and peri-articular area.', 'interventionNames': ['Drug: Dextrose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Methylprednisolone Acetate Group', 'description': 'Injection for Group B: A 27-gauge needle to be inserted in the 1st CMC joint, at which time 0.5 ml of 40mg methylprednisolone acetate mixed with 0.5 ml of 1% lidocaine solution is injected into intra and peri-articular area.', 'interventionNames': ['Drug: Methylprednisolone Acetate 40 MG/ML']}], 'interventions': [{'name': 'Dextrose', 'type': 'DRUG', 'description': 'See arm descriptions', 'armGroupLabels': ['Dextrose Group']}, {'name': 'Methylprednisolone Acetate 40 MG/ML', 'type': 'DRUG', 'description': 'See arm descriptions', 'armGroupLabels': ['Methylprednisolone Acetate Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Julianne Sutton, MPH', 'role': 'CONTACT', 'email': 'jsutton@kleinertkutz.com', 'phone': '5025620390'}, {'name': 'Rehan Zahid, MD', 'role': 'CONTACT', 'email': 'rzahid@kleinertkutz.com'}], 'overallOfficials': [{'name': 'Tuna Ozyurekoglu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'President'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Christine M. Kleinert Institute for Hand and Microsurgery', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kleinert, Kutz and Associates', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}