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Botulinum Toxin Versus Steroid Injection for Basal Joint Arthritis of the Thumb: a Randomized, Double Blind, Placebo-controlled Clinical Trial

This study is currently Recruiting

March 2011 By University of Missouri-Columbia

First Recieved on January 7, 2010

Last Updated on March 7, 2011

Sponsor: University of Missouri-Columbia
Collaborators:
Information provided by: University of Missouri-Columbia
Identifier: NCT01045694

Purpose

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.

Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

Inclusion Criteria: - Radiographic evidence of basal joint arthritis - Associated symptoms of basal joint arthritis including: - Pain - Decreased range of motion - Decreased thumb strength Exclusion Criteria: - Persons under the age of 18 - Women who are currently pregnant - Incompetent persons or persons otherwise incapable of effectively communicating the subjective experience of pain - Prior surgery on the joint - Injection in the last 12 months

Investigators

  • Investigator: Stephen H. Colbert, MD - Principal Investigator - University of Missouri-Department of Surgery-Division of Plastic Surgery

Locations

  • University of Missouri

    Columbia, Missouri 65212 United States

Conditions related to this trial:

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