RECRUITING

Injection of Botulinum Toxin for Thumb Carpometacarpal Arthritis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Botulinum Toxin Injection in the Management of Thumb Carpometacarpal Arthritis: a Randomized Controlled Trial

Quick Facts

Study Start:2023-08-27
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05990881

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult patients (\> 18 years old) with a diagnosis of thumb CMC OA
  2. * Diagnosis of thumb CMC OA
  3. * History, clinical exam, and radiographic findings, as done in prior studies on this topic.
  4. * Subjective: thumb or wrist pain at rest or with activity, joint stiffness
  5. * Exam: basal joint tenderness, decreased mobility, deformity, instability
  6. * Radiograph: joint space narrowing, subchondral sclerosis, osteophytes, subchondral cysts, Eaton-Littler stage.
  7. * Failed conservative management with oral pain medication and splinting for at least 3 months.
  1. * Severe osteoarthritis (Eaton-Littler stage 4) or too large osteophytes to allow for injection into the joint space Inflammatory arthritis
  2. * Any concomitant hand conditions (i.e. carpal tunnel, trigger finger, etc)
  3. * Prior significant hand trauma related to the thumb or first CMC joint
  4. * Prior intervention or hand surgery
  5. * Patients with fibromyalgia or complex regional pain syndrome (CRPS)
  6. * 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.

Contacts and Locations

Study Contact

Reena A Bhatt, MD
CONTACT
(401) 444-2701
RBhatt@brownhealth.org
Vinay Rao, MD
CONTACT
8133856534
vinayrao33@gmail.com

Study Locations (Sites)

235 Plain Street
Providence, Rhode Island, 02905
United States

Collaborators and Investigators

Sponsor: Rhode Island Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-27
Study Completion Date2026-07

Study Record Updates

Study Start Date2023-08-27
Study Completion Date2026-07

Terms related to this study

Keywords Provided by Researchers

  • Botulinum toxin
  • Carpometacarpal joint arthritis

Additional Relevant MeSH Terms

  • Carpometacarpal Sprain
  • Thumb Sprain
  • Clostridium; Botulinum