A Phase 1 interventional study of Botulinum toxin type A (Btx-A) and Cortisone in Osteoarthritis, Knee, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2012-11-07.
Sponsored by Mayo Clinic · Phase 1, Interventional, and Treatment
Patients with painful knee osteoarthritis will be randomly allocated to one of three groups. Each group will receive a knee injection of: 1) cortisone, 2) low dose Botox, or 3) high dose Botox. Patients will then be followed for 6 months to see if they have significant pain relief or improvement in their activity level after the injection.
Abstract Botulinum toxin type A (Btx-A) has been extensively studied and used clinically for its muscle paralyzing effects, but there is a growing body of evidence to support a role in pain modulation. Symptomatic osteoarthritis is a leading cause of pain, functional impairment, and disability, with significant indirect costs to society. Preliminary evidence suggests that Btx-A has a significant nociceptive effect, when injected intra-articularly, in to painful joints. The proposed study will evaluate the efficacy and safety of Btx-A injected intra-articularly in 60 subjects with moderate pain and functional impairment secondary to knee osteoarthritis, in a randomized, cortisone-controlled, double blind study, over a 6 month follow up period. If Btx-A is shown to be of equal or greater efficacy than cortisone in this patient population, it may be an excellent second line treatment for osteoarthritis, in multiple joints, where surgery is contraindicated or deferred due to age, comorbidities, or patient preference. Further studies examining the mechanism of action at the biochemical level, the clinical effect of Btx-A in other joints (in both osteoarthritis and inflammatory arthritis), the efficacy of Btx-A compared to hyaluronic acid (the only currently available injectable alternative to cortisone), and the side effect profile (effect on adjacent muscle strength, joint position sense, and long-term outcomes) would be indicated.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 62 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
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Exclusion criteria:
Drug: Cortisone
Drug: Botulinum toxin type A (Btx-A)
Drug: Botulinum toxin type A (Btx-A)
Participants randomized to Btx-A will be given either a low dose of 100 units or a high dose of 200 units. The Btx-A dose (100U or 200U) will be resonstituted with 4 cc of sterile non-preserved 0.9% sodium chloride solution.
Also known as: Botox
1 cc of 40 mg/cc methylprednisolone will be drawn up in 22 gauge needles with 3 cc of sterile non-preserved 0.9% sodium chloride solution.
Also known as: Medrol
Decrease in pain at 8 weeks post injection
Improvement in function at 2, 4, 8, 12, 26 weeks
Improvement in quality of life at 2, 4, 8, 12, 26 weeks
Decrease in pain at 2, 4, 12, 26 weeks
This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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