Is Botox Effective in Relieving Pain From Knee Osteoarthritis?

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00279903
First received: January 18, 2006
Last updated: November 6, 2012
Last verified: November 2012

January 18, 2006
November 6, 2012
November 2005
August 2008   (final data collection date for primary outcome measure)
Decrease in pain at 8 weeks post injection
Same as current
Complete list of historical versions of study NCT00279903 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Is Botox Effective in Relieving Pain From Knee Osteoarthritis?
Intra-articular Botulinum Toxin Type-A in Knee Osteoarthritis - a Randomized, Cortisone Controlled, Double Blind Study.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Osteoarthritis, Knee
  • 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
  • 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
  • Active Comparator: Cortisone
    Intervention: Drug: Cortisone
  • Experimental: Low Dose Btx-A
    Intervention: Drug: Botulinum toxin type A (Btx-A)
  • Experimental: High Dose Btx-A
    Intervention: Drug: Botulinum toxin type A (Btx-A)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
August 2008
August 2008   (final data collection date for primary outcome measure)

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.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00279903
1565-05
Yes
Not Provided
Mayo Clinic
Not Provided
Principal Investigator: Andrea J. Boon, M.D. Mayo Clinic
Mayo Clinic
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP