The purpose of this study is to determine whether intra-articular botulinum toxin type A is effective in the treatment of chronic joint pain.
Chronic shoulder pain unresponsive to oral medications and intra-articular corticosteroids is an important treatment problem, especially for the young, very old and those with complex medical problems that preclude joint reconstructive surgery. We hypothesized that intra-articular botulinum toxin could provide important joint pain relief in these patients. This is a prospective, double blined, placebo controlled 6month trial with an open label extension phase when pain returns to baseline levels (re-injection with 100units of botulinum toxin and 6 months followup thereafter). Comparisons: Intra-articular injection of botulinum toxin type a will be compared to intra-articular injection of placebo ( lidocaine then saline).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
Minneapolis VAMC
Minneapolis, Minnesota, United States
RECRUITING: Primary Outcomes:
Change in Pain Score
Change in Joint Function
Patient Global Assessment
Secondary Outcomes:
Pain Relief
Change in Health Status Quality of Life-SF36
Change in Disease specific Health Related QOL-WOOS
Function improvement - Range of Motion, SPADI, Simple Shoulder tes
Physican Assessment of Pain and Global Assessment of Improvement
Safety Measure,
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