Is Botox Effective in Relieving Pain From Knee Osteoarthritis?
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ClinicalTrials.gov Identifier: NCT00279903 |
Recruitment Status :
Completed
First Posted : January 20, 2006
Last Update Posted : November 7, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteoarthritis, Knee | Drug: Botulinum toxin type A (Btx-A) Drug: Cortisone | Phase 1 |
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 |

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 |
- Decrease in pain at 8 weeks post injection
- 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

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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:
- 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.

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 ClinicalTrials.gov identifier (NCT number): NCT00279903
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 |
Principal Investigator: | Andrea J. Boon, M.D. | Mayo Clinic |
ClinicalTrials.gov 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 |
Osteoarthritis Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Cortisone Botulinum Toxins Botulinum Toxins, Type A abobotulinumtoxinA |
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 |