The purpose of this study is to determine whether intra-articular injection of botulinum toxin is effective in the treatment of chronic knee paindue to arthritis.
Chronic knee pain unresponsive to oral medications and intra-articular corticosteroids and viscosupplements 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 bootulinum toxin type a will be compared to intra-articular injection of lidocaine the saline.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
Minneapolis VAMC
Minneapolis, Minnesota, United States
RECRUITINGChange in Pain Score
Change in Joint Function
Patient Global Assessment
Pain Relief
Change in Health Status Quality of Life-SF36
Change in Disease specific Health Related QOL-WOMAC
Function improvement by Timed Stands Test and Range of Motion
Physican Assessment of Pain and Global Assessment of Improvement
Safety Measure,
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