Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT06902805
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-18
First Post:
2025-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Two Ultrasound-guided Intra-articular Injections of Botox® Combined With Custom-made Rigid Splinting in Painful Base-of-thumb Osteoarthritis.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2028-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-15', 'studyFirstSubmitDate': '2025-03-24', 'studyFirstSubmitQcDate': '2025-03-28', 'lastUpdatePostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Base-of-thumb pain on a self-administered 11-point numeric rating scale', 'timeFrame': '6 months', 'description': 'French version of the self-administered base-of-thumb pain numeric rating scale (0: no pain to 100: maximal pain)'}], 'secondaryOutcomes': [{'measure': 'Base-of-thumb pain on a self-administered 11-point numeric rating scale', 'timeFrame': '1 and 12 months', 'description': 'French version of the self-administered base-of-thumb pain numeric rating scale (0: no pain to 100: maximal pain)'}, {'measure': 'Hand-specific activity limitations on the self-administered Cochin Hand Function Scale', 'timeFrame': '6 and 12 months', 'description': 'mean change from baseline in hand-specific activity limitations in the previous 2 weeks on the self-administered Cochin Hand Function Scale (0: no limitations to 90: maximal limitations) at 6 and 12 months'}, {'measure': 'patient global assessment on a self-administered 11-point numeric rating scale', 'timeFrame': '6 and 12 months', 'description': 'mean change from baseline in patient global assessment on a self-administered 11-point numeric rating scale (0: worst possible condition to 100: best possible condition) at 6 and 12 months'}, {'measure': 'health-related quality of life on the self-administered EQ-5D-5L questionnaire', 'timeFrame': '6 and 12 months', 'description': 'mean change from baseline in health-related quality of life on the self-administered EQ-5D-5L questionnaire (0: death, 1: best quality of life) at 6 and 12 months'}, {'measure': 'Osteoarthritis Research Society International-Outcome Measures in Rheumatology response', 'timeFrame': '6 and 12 months', 'description': 'Osteoarthritis Research Society International-Outcome Measures in Rheumatology response (Response / No response)'}, {'measure': 'estimated total costs and incremental cost-utility ratio', 'timeFrame': '12 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['base-of-thumb osteoarthritis'], 'conditions': ['Base-of-thumb Osteoarthritis', 'Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The main objective of this study will be to compare the effects of 2 intra-articular injections of onabotulinumtoxinA with those of 1 intra-articular injection of onabotulinumtoxinA and 1 of normal saline and those of 2 intra-articular injections of normal saline on base-of-thumb pain at 6 months after the first injection.', 'detailedDescription': 'The base of the thumb is a frequent location of osteoarthritis. Base-of-thumb osteoarthritis affects middle-aged and older individuals and results in base-of-thumb pain and limitations in hand-specific activities. For the medium and long term, evidence suggests that splinting could reduce pain and improve hand function. For the short term, a combination of conservative treatments is recommended, with small-to-moderate treatment effect. However, use of intra-articular treatments (e.g., glucocorticoids and hyaluronan) for the short and medium term is currently debated. Use of intra-articular botulinum toxin A injection as a pain modulator in joint diseases has recently raised interest. Botulinum toxin A is a neurotoxin produced by Clostridium botulinum that inhibits acetylcholine release into the synaptic cleft in cholinergic nerve terminals. Additionally, treatment with botulinum toxin A showed intrinsic antinociceptive effects in various animal models of joint diseases.\n\nIn a pilot single-centred randomized controlled trial of 60 participants with painful base-of-thumb osteoarthritis, the investigators compared the effects of a single intra-articular injection of onabotulinumtoxinA (Botox® ) with those of a single intra-articular injection of normal saline on base-of-thumb pain, and found a significant reduction in pain.\n\nSeveral perspectives raised from this pilot study. Like in the treatment of spasticity, repeated courses of intra-articular injections onabotulinumtoxinA may be necessary to obtain sustained analgesic effects over time. A replication of these findings in a multicentred setting, analysis of cost-effectiveness and description of safety at longer term are also needed before the official recommendation of this treatment. In RHIBOT II, the investigators hypothesize that 2 ultrasound-guided intra-articular injections of onabotulinumtoxinA, as an add-on therapy to custom-made rigid splinting, could reduce base-of-thumb pain at 6 months after the first injection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Individuals aged at least 18 years;\n\n * Pain intensity of at least 30 on a self-administered 11-point pain numeric rating scale (0: no pain to 100: maximal pain);\n * Pain involving the base of the thumb;\n * X-ray evidence of trapezometacarpial osteoarthritis with at least two of the following items involving the trapezometacarpial joint: osteophytes, joint space narrowing, subchondral bone sclerosis, or subchondral cysts;\n * 1990 ACR classification criteria for hand osteoarthritis adapted to trapezometacarpial osteoarthritis.\n * Patient able to give written informed consent prior to participation in the study\n * Affiliation with a mode of social security (profit or being entitled).\n * Negative pregnancy test in women of childbearing potential\n\nExclusion Criteria:\n\n* • Secondary osteoarthritis;\n\n * History of thumb surgery, inflammatory or crystal-associated rheumatic disease, or epilepsy;\n * Uncontrolled dysphagia, pneumonia, cardiovascular diseases, or clinical or subclinical signs of neuromuscular transmission disorders;\n * Contra-indication to onabotulinumtoxinA;\n * Neurological disorders involving the hands other than carpal tunnel syndrome;\n * Collagen disorders involving the hands;\n * Osteoarthritis predominating at the scaphotrapezial joint on x-ray;\n * Bilateral trapezometacarpial osteoarthritis without a predominant painful side;\n * Hand or wrist trauma for up to 2 months;\n * Intra-articular treatments for up to 2 months;\n * Use of IM, IV or oral corticosteroids for up to 2 months.\n * Protected adults (including individual under guardianship by court order)\n * Pregnant women and lactation; lack of contraception for women of childbearing potential\n * Patient participating in another investigational therapeutic study\n * Patient unable to speak and read french'}, 'identificationModule': {'nctId': 'NCT06902805', 'acronym': 'RHIBOTII', 'briefTitle': 'Efficacy of Two Ultrasound-guided Intra-articular Injections of Botox® Combined With Custom-made Rigid Splinting in Painful Base-of-thumb Osteoarthritis.', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Medium-and Long-term Efficacy of Two Ultrasound-guided Intra-articular Injections of onabotulinumtoxinA (Botox®) Combined With Custom-made Rigid Splinting in Painful Base-of-thumb Osteoarthritis : a Randomized Double-blind Controlled Trial in Three-parallel Arms', 'orgStudyIdInfo': {'id': 'APHP230823'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2 intra-articular injections of onabotulinumtoxinA', 'interventionNames': ['Drug: OnabotulinumtoxinA']}, {'type': 'EXPERIMENTAL', 'label': '1 intra-articular injection of onabotulinumtoxinA and 1 of normal saline', 'interventionNames': ['Drug: OnabotulinumtoxinA', 'Drug: Normal saline (placebo)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2 intra-articular injections of normal saline', 'interventionNames': ['Drug: Normal saline (placebo)']}], 'interventions': [{'name': 'OnabotulinumtoxinA', 'type': 'DRUG', 'description': 'intra-articular injection', 'armGroupLabels': ['1 intra-articular injection of onabotulinumtoxinA and 1 of normal saline', '2 intra-articular injections of onabotulinumtoxinA']}, {'name': 'Normal saline (placebo)', 'type': 'DRUG', 'description': 'intra-articular injection', 'armGroupLabels': ['1 intra-articular injection of onabotulinumtoxinA and 1 of normal saline', '2 intra-articular injections of normal saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'contacts': [{'name': 'Christelle Nguyen, MD, PhD', 'role': 'CONTACT', 'email': 'christelle.nguyen2@aphp.fr', 'phone': '01 58 41 29 45', 'phoneExt': '+33'}], 'facility': "Assistance Publique - Hôpitaux de Paris, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis du Pr François Rannou, Hôpital Cochin", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Christelle NGUYEN, MD, PhD', 'role': 'CONTACT', 'email': 'christelle.nguyen2@aphp.fr', 'phone': '01 58 41 29 45', 'phoneExt': '+33'}, {'name': 'Laetitia PEAUDECERF, PhD', 'role': 'CONTACT', 'email': 'laetitia.peaudecerf@aphp.fr', 'phone': '01 58 41 12 13', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Christelle NGUYEN, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Organizational Affiliation: Université Paris Cité, Faculté de Santé | UFR de Médecine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}