Recruiting
Phase 3

Botulinum Toxin

Sponsor:

Rhode Island Hospital

Code:

NCT05990881

Conditions

Carpometacarpal Sprain

Thumb Sprain

Clostridium; Botulinum

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Botulinum toxin

Standard-of-care corticosteroid injections

Study Details

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

Study ID

NCT05990881

Start date

Aug 27, 2023

Status verified date

Nov, 2024

Completion date

Jul, 2026

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Control

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

experimental: Botulinum Toxin

Patients in this group will receive a Botulinum Toxin injection.

Interventions

Botulinum toxin

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

Standard-of-care corticosteroid injections

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

Primary outcome measure

  • Thumb Pain [ Time Frame: 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). ]

Central Contacts and Locations

Central contacts

Reena A Bhatt, MD

(401) 444-2701RBhatt@brownhealth.org

Vinay Rao, MD

8133856534vinayrao33@gmail.com

Locations

235 Plain Street

Recruiting

Providence, Rhode Island, United States, 02905

Contacts

Reena A Bhatt, MD

(401) 444-2701RBhatt@brownhealth.org

Sarah A Uriarte, BS

323-528-4514sarah_uriarte@brown.edu

More Information

Sponsor

Rhode Island Hospital

Last update posted

Nov 20, 2024

Last verified

Nov, 2024

Keywords

  • Botulinum toxin
  • Carpometacarpal joint arthritis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rhode Island Hospital on 2024-11-20.