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Is Botox Effective in Relieving Pain From Knee Osteoarthritis?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00279903
Recruitment Status : Completed
First Posted : January 20, 2006
Last Update Posted : November 7, 2012
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: Botulinum toxin type A (Btx-A) Drug: Cortisone Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Intra-articular Botulinum Toxin Type-A in Knee Osteoarthritis - a Randomized, Cortisone Controlled, Double Blind Study.
Study Start Date : November 2005
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Osteoarthritis

Arm Intervention/treatment
Active Comparator: Cortisone Drug: Cortisone
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.
Other Name: Medrol

Experimental: Low Dose 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.
Other Name: Botox

Experimental: High Dose 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.
Other Name: Botox

Primary Outcome Measures :
  1. Decrease in pain at 8 weeks post injection

Secondary Outcome Measures :
  1. Improvement in function at 2, 4, 8, 12, 26 weeks
  2. Improvement in quality of life at 2, 4, 8, 12, 26 weeks
  3. Decrease in pain at 2, 4, 12, 26 weeks

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00279903

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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
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Principal Investigator: Andrea J. Boon, M.D. Mayo Clinic
Layout table for additonal information Identifier: NCT00279903    
Other Study ID Numbers: 1565-05
First Posted: January 20, 2006    Key Record Dates
Last Update Posted: November 7, 2012
Last Verified: November 2012
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents