Is Botox Effective in Relieving Pain From Knee Osteoarthritis?

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; Cortisone; Cortisone acetate; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion criteria:

1. A history of knee joint pain for greater than 6 months.

2. Medial or lateral tibiofemoral joint line tenderness.

3. Unilateral knee pain 6/10 or greater, on average, on the visual analog scale (VAS), that interferes with function most days per week.

4. Prior failed treatment with acetaminophen and/or non steroidal anti-inflammatory medications, and physical therapy (quadriceps strengthening).

5. Kellgren grade II or III radiographic changes of osteoarthritis.

Exclusion criteria:

1. Age less than 40 years.

2. Anticoagulation with warfarin or heparin.

3. Known allergy or sensitivity to any of the components of the study medications.

4. Body mass index greater than 35.

5. Previous major reconstructive surgery on the affected knee.

6. Previous arthroscopic surgery on the affected knee in the past 12 months.

7. History of crystal induced arthropathy.

8. Use of aminoglycoside antibiotics, curare-like agents, or history of neuromuscular disease such as myasthenia gravis, amyotrophic lateral sclerosis, or myopathy.

9. History of or evidence of active rheumatologic disease, diabetes, severe peripheral neuropathy, clinically evident cardiac or respiratory disease that interferes with functional status, or other serious diseases, including psychiatric disorders.

10. Evidence of recent alcohol or drug abuse, or history of medication misuse or addiction.

11. Females who are pregnant, breastfeeding, or planning a pregnancy during the study, or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study.

12. Intra-articular (knee) or systemic steroids in the past 6 months, or intra-articular knee hyaluronic acid injection in the past 6 months.

13. Patients who rate their average daily pain as less than 6 on a 10 point VAS scale at the screening visit.

14. Concurrent participation in another investigational drug or device study or participation in the 30 days immediately prior to study enrollment.