A Phase 3 interventional study of Botulinum toxin and Standard-of-care corticosteroid injections in Carpometacarpal Sprain, Thumb Sprain and Clostridium; Botulinum, sponsored by Rhode Island Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-20.
Sponsored by Rhode Island Hospital · Phase 3, Interventional, and Treatment
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.
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.
20 studies on the registry are indexed under Botulism; 3 are open to participants now.
This study's planned enrollment of 50 is above the median of 29 across 14 interventional studies indexed under Botulism.
Browse Botulism studies →Rhode Island Hospital is the lead sponsor of 191 studies on the registry; 36 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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Exclusion Criteria:
Patients in this group will receive standard-of-care corticosteroid injections.
Drug: Standard-of-care corticosteroid injections
Patients in this group will receive a Botulinum Toxin injection.
Drug: Botulinum toxin
Patients in this group will receive an injection of Botulinum toxin.
Also known as: Botox
Patients in this group will receive an injection of corticosteroid injections, which are considered standard of care.
Thumb Pain
The primary outcome of interest is an improvement of thumb-specific pain scored by a change in the visual analog scale (VAS) pain score. VAS was chosen based on strong evidence supporting its validity in assessing pain in patients with OA. VAS will be measured by asking patients to make a vertical mark on a 10-cm horizontal line with 0 (far-left hash mark) representing no pain and 10 (far-right hash mark) representing the worst pain of their life. Scores will be quantified by measuring the difference in the distance from the left hash mark to the patient's mark in millimeters using a caliper. Based on the literature, the minimal clinically important difference (MCID) for VAS is 1.6 cm and 2.2 cm for substantial clinical benefit (SCB). Pre-injection VAS scores will be taken to first establish a baseline.
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).
Grip Strength
Secondary outcomes will include grip strength measured by asking a patient to compress a Jamar hydraulic hand dynamometer with maximal exertion at 2 seconds. This will be performed 3 times in each hand, alternating between the study hand and the contralateral hand, in order to provide rest between attempts and establish a baseline for the unaffected or less affected hand. The average of 3 values for each hand will be computed and recorded. In a similar fashion, key pinch strength will be measured using a pinch dynamometer.
Time frame: 2-weeks, 1-month, 6-months, and 1-year (primary study endpoint).
Thumb range of motion
Thumb range of motion (ROM) will be measured for the basal joint: (1) in-plane thumb abduction values represent the angle (in degrees) between the axis of the first and second metacarpal, with the apex centered over the scaphoid when the hand is placed flat upon the exam table, (2) out-of-plane thumb abduction values represent the angle (in degrees) between the axis of the first and second metacarpal bones when the dorsum of the hand is placed flat upon the exam table and the patient is asked to point their thumb vertically toward the ceiling; (3) metacarpophalangeal (MCP) values will consist of measurement of the angle between the axis of the metacarpal and proximal phalangeal bones of the first digit, as means of assessing laxity in the adjacent joint, which is commonly increased as a sequelae of basilar joint arthritis.
Time frame: 2-weeks, 1-month, 6-months, and 1-year (primary study endpoint).
Started Aug 2023 (actual). Primary completion is estimated for Dec 2025, 28 months after the start.
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Studies of the drug tested here: Botulinum Toxins