Efficacy of Two Ultrasound-guided Intra-articular Injections of Botox® Combined With Custom-made Rigid Splinting in Painful Base-of-thumb Osteoarthritis.

NCT06902805 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: APHP230823
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Base-of-thumb Osteoarthritis; Osteoarthritis

Keywords

base-of-thumb osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Base-of-thumb pain on a self-administered 11-point numeric rating scale

  French version of the self-administered base-of-thumb pain numeric rating scale (0: no pain to 100: maximal pain)

  6 months

Secondary Outcomes (6)

• Base-of-thumb pain on a self-administered 11-point numeric rating scale

  1 and 12 months

• Hand-specific activity limitations on the self-administered Cochin Hand Function Scale

  6 and 12 months

• patient global assessment on a self-administered 11-point numeric rating scale

  6 and 12 months

• health-related quality of life on the self-administered EQ-5D-5L questionnaire

  6 and 12 months

• Osteoarthritis Research Society International-Outcome Measures in Rheumatology response

  6 and 12 months

Study Arms (3)

2 intra-articular injections of onabotulinumtoxinA

EXPERIMENTAL

Drug: OnabotulinumtoxinA

1 intra-articular injection of onabotulinumtoxinA and 1 of normal saline

EXPERIMENTAL

Drug: OnabotulinumtoxinA; Drug: Normal saline (placebo)

2 intra-articular injections of normal saline

PLACEBO COMPARATOR

Drug: Normal saline (placebo)

Interventions

OnabotulinumtoxinA DRUG

intra-articular injection

1 intra-articular injection of onabotulinumtoxinA and 1 of normal saline; 2 intra-articular injections of onabotulinumtoxinA

Normal saline (placebo) DRUG

intra-articular injection

1 intra-articular injection of onabotulinumtoxinA and 1 of normal saline; 2 intra-articular injections of normal saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged at least 18 years;
• Pain intensity of at least 30 on a self-administered 11-point pain numeric rating scale (0: no pain to 100: maximal pain);
• Pain involving the base of the thumb;
• 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;
• ACR classification criteria for hand osteoarthritis adapted to trapezometacarpial osteoarthritis.
• Patient able to give written informed consent prior to participation in the study
• Affiliation with a mode of social security (profit or being entitled).
• Negative pregnancy test in women of childbearing potential

You may not qualify if:

• Secondary osteoarthritis;
• History of thumb surgery, inflammatory or crystal-associated rheumatic disease, or epilepsy;
• Uncontrolled dysphagia, pneumonia, cardiovascular diseases, or clinical or subclinical signs of neuromuscular transmission disorders;
• Contra-indication to onabotulinumtoxinA;
• Neurological disorders involving the hands other than carpal tunnel syndrome;
• Collagen disorders involving the hands;
• Osteoarthritis predominating at the scaphotrapezial joint on x-ray;
• Bilateral trapezometacarpial osteoarthritis without a predominant painful side;
• Hand or wrist trauma for up to 2 months;
• Intra-articular treatments for up to 2 months;
• Use of IM, IV or oral corticosteroids for up to 2 months.
• Protected adults (including individual under guardianship by court order)
• Pregnant women and lactation; lack of contraception for women of childbearing potential
• Patient participating in another investigational therapeutic study
• Patient unable to speak and read french

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

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

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Botulinum Toxins, Type A; Saline Solution

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Christelle NGUYEN, MD,PhD

  Organizational Affiliation: Université Paris Cité, Faculté de Santé | UFR de Médecine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christelle NGUYEN, MD, PhD

CONTACT

01 58 41 29 45; christelle.nguyen2@aphp.fr

Laetitia PEAUDECERF, PhD

CONTACT

01 58 41 12 13; laetitia.peaudecerf@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: March 30, 2025
• Study Start: May 1, 2025
• Primary Completion: October 1, 2025
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)