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New treatment option for Carpometacarpal Sprain
Official title Injection of Botulinum Toxin for Thumb Carpometacarpal Arthritis
ClinicalTrials.gov ID: NCT05990881
What this study is testing
What is Botulinum toxin?
Botulinum toxin is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for carpometacarpal sprain.
Also referred to as Botox.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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...
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Providence, Rhode Island, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Providence, Rhode Island, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.