Status:
COMPLETED
Is Botox Effective in Relieving Pain From Knee Osteoarthritis?
Lead Sponsor:
Mayo Clinic
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
40+ years
Phase:
PHASE1
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. Patien...
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...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- A history of knee joint pain for greater than 6 months.
- Medial or lateral tibiofemoral joint line tenderness.
- Unilateral knee pain 6/10 or greater, on average, on the visual analog scale (VAS), that interferes with function most days per week.
- Prior failed treatment with acetaminophen and/or non steroidal anti-inflammatory medications, and physical therapy (quadriceps strengthening).
- Kellgren grade II or III radiographic changes of osteoarthritis.
- Exclusion criteria:
- Age less than 40 years.
- Anticoagulation with warfarin or heparin.
- Known allergy or sensitivity to any of the components of the study medications.
- Body mass index greater than 35.
- Previous major reconstructive surgery on the affected knee.
- Previous arthroscopic surgery on the affected knee in the past 12 months.
- History of crystal induced arthropathy.
- Use of aminoglycoside antibiotics, curare-like agents, or history of neuromuscular disease such as myasthenia gravis, amyotrophic lateral sclerosis, or myopathy.
- 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.
- Evidence of recent alcohol or drug abuse, or history of medication misuse or addiction.
- 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.
- Intra-articular (knee) or systemic steroids in the past 6 months, or intra-articular knee hyaluronic acid injection in the past 6 months.
- Patients who rate their average daily pain as less than 6 on a 10 point VAS scale at the screening visit.
- Concurrent participation in another investigational drug or device study or participation in the 30 days immediately prior to study enrollment.
Exclusion
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00279903
Start Date
November 1 2005
End Date
August 1 2008
Last Update
November 7 2012
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905