Is Botox Effective in Relieving Pain From Knee Osteoarthritis?

Phase 1

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Drug: Botulinum toxin type A (Btx-A); Drug: Cortisone

• Registration Number: NCT00279903
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2006-01-18
• Study First Submitted QC: 2006-01-18
• Study First Posted: 2006-01-20
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-06
• Last Update Posted: 2012-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Dose Btx-A	Botulinum toxin type A (Btx-A)	-
High Dose Btx-A	Botulinum toxin type A (Btx-A)	-
Cortisone	Cortisone	-

Primary Outcome Measures

Name	Time	Method
Decrease in pain at 8 weeks post injection

Secondary Outcome Measures

Name	Time	Method
Decrease in pain at 2, 4, 12, 26 weeks
Improvement in function at 2, 4, 8, 12, 26 weeks
Improvement in quality of life at 2, 4, 8, 12, 26 weeks

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States