Injection of Botulinum Toxin for Thumb Carpometacarpal Arthritis

NCT05990881 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 2006564-3
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to gather information on the safety and effectiveness of botulinum toxin injection (or Botox) in the treatment of thumb joint pain/arthritis. People with thumb joint pain or arthritis usually receive steroid injections to help with the pain. However, this medicine does not always work well and also carries known important side effects. There is currently no alternative to this injection medicine. This clinical trial seeks to investigate botulinum toxin as a possible alternative to steroid injection. The difference between Botox and steroid injections is that they are different medicines and work in different ways. Botox, as it is being used in this study, is not FDA-approved. It is therefore considered an investigational medicine.

Conditions

Carpometacarpal Sprain; Thumb Sprain; Clostridium; Botulinum

Keywords

Botulinum toxin; Carpometacarpal joint arthritis

Outcome Measures

Primary Outcomes (1)

• Thumb Pain

  The primary outcome of interest is an improvement of thumb-specific pain scored by a change in the visual analog scale (VAS) pain score. VAS was chosen based on strong evidence supporting its validity in assessing pain in patients with OA. VAS will be measured by asking patients to make a vertical mark on a 10-cm horizontal line with 0 (far-left hash mark) representing no pain and 10 (far-right hash mark) representing the worst pain of their life. Scores will be quantified by measuring the difference in the distance from the left hash mark to the patient's mark in millimeters using a caliper. Based on the literature, the minimal clinically important difference (MCID) for VAS is 1.6 cm and 2.2 cm for substantial clinical benefit (SCB). Pre-injection VAS scores will be taken to first establish a baseline.

  Post-injection VAS scores will then be taken at each subsequent follow-up visit: 2-weeks, 1-month, 6-months, and 1-year (primary study endpoint).

Secondary Outcomes (2)

• Grip Strength

  2-weeks, 1-month, 6-months, and 1-year (primary study endpoint).

• Thumb range of motion

  2-weeks, 1-month, 6-months, and 1-year (primary study endpoint).

Study Arms (2)

Control

ACTIVE COMPARATOR

Patients in this group will receive standard-of-care corticosteroid injections.

Drug: Standard-of-care corticosteroid injections

Botulinum Toxin

EXPERIMENTAL

Patients in this group will receive a Botulinum Toxin injection.

Drug: Botulinum toxin

Interventions

Botulinum toxin DRUG

Patients in this group will receive an injection of Botulinum toxin.

Also known as: Botox

Botulinum Toxin

Standard-of-care corticosteroid injections DRUG

Patients in this group will receive an injection of corticosteroid injections, which are considered standard of care.

Control

Eligibility Criteria

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

You may qualify if:

• Adult patients (\> 18 years old) with a diagnosis of thumb CMC OA
• Diagnosis of thumb CMC OA
• History, clinical exam, and radiographic findings, as done in prior studies on this topic.
• Subjective: thumb or wrist pain at rest or with activity, joint stiffness
• Exam: basal joint tenderness, decreased mobility, deformity, instability
• Radiograph: joint space narrowing, subchondral sclerosis, osteophytes, subchondral cysts, Eaton-Littler stage.
• Failed conservative management with oral pain medication and splinting for at least 3 months.

You may not qualify if:

• Severe osteoarthritis (Eaton-Littler stage 4) or too large osteophytes to allow for injection into the joint space Inflammatory arthritis
• Any concomitant hand conditions (i.e. carpal tunnel, trigger finger, etc)
• Prior significant hand trauma related to the thumb or first CMC joint
• Prior intervention or hand surgery
• Patients with fibromyalgia or complex regional pain syndrome (CRPS)
• Pregnant and breastfeeding patients will also be excluded. We also will exclude individuals attempting to conceive or who could become pregnant within 6-months of treatment.

Sponsors & Collaborators

• Rhode Island Hospital: lead

Study Sites (1)

235 Plain Street

Providence, Rhode Island, 02905, United States

RECRUITING

Related Publications (7)

• Haara MM, Heliovaara M, Kroger H, Arokoski JP, Manninen P, Karkkainen A, Knekt P, Impivaara O, Aromaa A. Osteoarthritis in the carpometacarpal joint of the thumb. Prevalence and associations with disability and mortality. J Bone Joint Surg Am. 2004 Jul;86(7):1452-7. doi: 10.2106/00004623-200407000-00013.

  PMID: 15252092 BACKGROUND

• Weiss AC, Goodman AD. Thumb Basal Joint Arthritis. J Am Acad Orthop Surg. 2018 Aug 15;26(16):562-571. doi: 10.5435/JAAOS-D-17-00374.

  PMID: 29969109 BACKGROUND

• Pickrell BB, Eberlin KR. Thumb Basal Joint Arthritis. Clin Plast Surg. 2019 Jul;46(3):407-413. doi: 10.1016/j.cps.2019.02.010.

  PMID: 31103085 BACKGROUND

• Trellu S, Dadoun S, Berenbaum F, Fautrel B, Gossec L. Intra-articular injections in thumb osteoarthritis: A systematic review and meta-analysis of randomized controlled trials. Joint Bone Spine. 2015 Oct;82(5):315-9. doi: 10.1016/j.jbspin.2015.02.002. Epub 2015 Mar 14.

  PMID: 25776442 BACKGROUND

• Jankovic J, Brin MF. Therapeutic uses of botulinum toxin. N Engl J Med. 1991 Apr 25;324(17):1186-94. doi: 10.1056/NEJM199104253241707. No abstract available.

  PMID: 2011163 BACKGROUND

• Singh JA. Use of botulinum toxin in musculoskeletal pain. F1000Res. 2013 Feb 15;2:52. doi: 10.12688/f1000research.2-52.v2. eCollection 2013.

  PMID: 24715952 BACKGROUND

• Cote TR, Mohan AK, Polder JA, Walton MK, Braun MM. Botulinum toxin type A injections: adverse events reported to the US Food and Drug Administration in therapeutic and cosmetic cases. J Am Acad Dermatol. 2005 Sep;53(3):407-15. doi: 10.1016/j.jaad.2005.06.011.

  PMID: 16112345 BACKGROUND

MeSH Terms

Conditions

Botulism

Interventions

Botulinum Toxins; Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Neuromuscular Junction Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurotoxicity Syndromes; Foodborne Diseases; Poisoning; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Central Study Contacts

Reena A Bhatt, MD

CONTACT

(401) 444-2701; RBhatt@brownhealth.org

Vinay Rao, MD

CONTACT

8133856534; vinayrao33@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will not be informed of which group they are assigned. A small bandage will be placed over the injection site after the injection is performed since corticosteroid injections may cause mild, benign skin discoloration.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There will be two groups to which patients will be randomized: the control group, in which patients will receive the standard treatment for carpometacarpal joint arthritis (i.e., corticosteroid injection), and the experimental group, in which patients receive Botulinum toxin injection.

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 14, 2023
• Study Start: August 27, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 20, 2024

Record last verified: 2024-11

Locations

US (1)