drugset / Trial / NCT01045694

Botulism Toxin Injection as a Treatment for Arthritis of the Basal Thumb Joint

NCT01045694

Phase 4 Terminated 8 enrolled University of Missouri-Columbia
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Basal arthritis of the thumb is a common condition with increased prevalence in post-menopausal women, obese persons, and the elderly. Surgical options are varied and efficacious, but not all patients are candidates for surgery. The successes and pitfalls of previous, similar trials are carefully considered in the creation of our own. Though steroid injection is the standard of care in basal joint arthritis, current data does not support its efficacy beyond placebo effect. No trial has yet examined the efficacy of botulinum toxin type A (BTX-A) injection into the basal thumb joint nor compared it to steroid. Since efficacy of steroid is questionable at best, our hope is that BTX-A injection of the basal joint might be the next great tool in treating this common, debilitating disease.

Timeline

Start
2011-03
Primary completion
2012-08
Completion
2015-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin type A Protein / enzyme biologic 50 iu Other
Comparator Triamcinolone Acetonide Other / unclassified 40 mg/ml Other
Comparator Lidocaine Other / unclassified 2 % Other