No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
50 (estimated)
Sponsor
Rhode Island Hospital · Other
Who this trial is looking for
This trial is looking for adults with thumb joint pain or arthritis to test an injection treatment. Participants will receive an injection of botulinum toxin to see if it helps with their pain.
Are You a Good Fit for This Trial?
You may be able to join if
I am over 18 years old.
I have been diagnosed with thumb arthritis.
I have pain or stiffness in my thumb or wrist.
I have tenderness and decreased mobility in my thumb joint.
I have not found relief from pain medication and splinting for at least 3 months.
You may not be able to join if
I have severe osteoarthritis in my thumb.
I have any other hand conditions.
I have had significant hand trauma related to my thumb.
I have had any prior hand surgery.
I have fibromyalgia or complex regional pain syndrome.
I am pregnant or breastfeeding.
I am trying to conceive or could become pregnant within 6 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 al…
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.
Trial Locations
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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 …
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.
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