Injection of Botulinum Toxin for Thumb Carpometacarpal Arthritis

NCT ID: NCT05990881

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-27
• Study Completion Date: 2026-07-31

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.

Detailed Description

Thumb carpometacarpal (CMC) osteoarthritis (OA) is one of the most common conditions treated by hand surgeons in the US. The treatment algorithm includes a stepwise strategy starting with conservative management and escalating to operative interventions when nonoperative measures fail to control pain or there is progression to a painful joint. Intra-articular injection of steroids represents a mainstay in the treatment approach for patients with thumb CMC OA, but despite its ubiquity, the American College of Rheumatology only conditionally recommends steroid injections due to a lack of evidence. Additionally, steroid injections carry significant risks, including the possibility of tissue atrophy, skin hypopigmentation, and joint arthropathy. As a result, alternative means have been sought to better treat pain and potentially delay the need for surgery. Botulinum toxin (BoNT) may be one such alternative.

BoNT is produced by Clostridium botulinum and exerts temporary neuromodulation by rapidly and strongly binding to presynaptic cholinergic nerve terminals. BoNT has also been shown to inhibit the secretion of pain mediators from the nerve endings of the dorsal root ganglia, reduce local inflammation around nerve endings, deactivate sodium channels, and perform retrograde axonal transport. Due to the growing evidence of efficacy in treating neuropathic pain, the use of BoNT has become incorporated in the management of chronic migraines, trigeminal neuralgia, spinal cord injuries, and post-stroke pain syndrome. Additionally, intra-articular BoNT injections were shown to decrease pain in patients with knee and shoulder refractory arthritis.

The investigators propose that intra-articular BoNT injections may decrease pain in patients with thumb CMC OA through the chemical denervation of articular pain fibers.

Conditions

Carpometacarpal Sprain; Thumb Sprain; Clostridium; Botulinum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

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

Group Type: ACTIVE_COMPARATOR

Standard-of-care corticosteroid injections

Intervention Type: DRUG

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

Botulinum Toxin

Patients in this group will receive a Botulinum Toxin injection.

Group Type: EXPERIMENTAL

Botulinum toxin

Intervention Type: DRUG

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

Interventions

Botulinum toxin

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

Intervention Type: DRUG

Standard-of-care corticosteroid injections

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

Intervention Type: DRUG

Other Intervention Names

Botox

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rhode Island Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

235 Plain Street

Providence, Rhode Island, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Reena A Bhatt, MD

Role: CONTACT

RBhatt@brownhealth.org

(401) 444-2701

Vinay Rao, MD

Role: CONTACT

vinayrao33@gmail.com

8133856534

Facility Contacts

Reena A Bhatt, MD

Role: primary

RBhatt@brownhealth.org

(401) 444-2701

Sarah A Uriarte, BS

Role: backup

sarah_uriarte@brown.edu

323-528-4514

References

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.

Reference Type: BACKGROUND

PMID: 15252092 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29969109 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31103085 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25776442 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 2011163 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 24715952 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16112345 (View on PubMed)

Other Identifiers

2006564-3

Identifier Type: -

Identifier Source: org_study_id