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Sponsors and Collaborators: |
Minneapolis Veterans Affairs Medical Center Allergan Minnesota Veterans Research Institute |
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Information provided by: | Minneapolis Veterans Affairs Medical Center |
ClinicalTrials.gov Identifier: | NCT00211679 |
The purpose of this study is to determine whether intra-articular injection of botulinum toxin is effective in the treatment of chronic knee paindue to arthritis.
Condition | Intervention | Phase |
---|---|---|
Arthritis Pain |
Drug: Botulinum Toxin Type A |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Intra-articularInjection of Botulinum Toxin Type a for the Treatment of Chronic Knee Pain: A Randomized, Placebo Controlled, Double Blind Study |
Estimated Enrollment: | 40 |
Study Start Date: | June 2004 |
Estimated Study Completion Date: | June 2007 |
Chronic knee pain unresponsive to oral medications and intra-articular corticosteroids and viscosupplements is an important treatment problem, especially for the young, very old and those with complex medical problems that preclude joint reconstructive surgery. We hypothesized that intra-articular botulinum toxin could provide important joint pain relief in these patients. This is a prospective, double blined, placebo controlled 6month trial with an open label extension phase when pain returns to baseline levels (re-injection with 100units of botulinum toxin and 6 months followup thereafter.
Comparisons: Intra-articular injection of bootulinum toxin type a will be compared to intra-articular injection of lidocaine the saline.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Male or female subjects, 18 years of age or older.
Exclusion Criteria:
Contact: Maren L Mahowald, MD | 6124674190 | mahow001@umn.edu |
Contact: Jasvinder A Singh, MD, MPH | 6124674190 | Jasvinder.Singh@va.gov |
United States, Minnesota | |
Minneapolis VAMC | Recruiting |
Minneapolis, Minnesota, United States, 55417 | |
Principal Investigator: Maren L Mahowald, MD | |
Sub-Investigator: Jasvinder A Singh, MD MPPH | |
Sub-Investigator: Hollis E Krug, MD |
Principal Investigator: | Maren L Mahowad, MD | Minneapolis VAMC |
Study ID Numbers: | Protocol Number 03393B |
Study First Received: | September 13, 2005 |
Last Updated: | September 13, 2005 |
ClinicalTrials.gov Identifier: | NCT00211679 |
Health Authority: | United States: Food and Drug Administration |
Joint pain Knee Pain Arthritis Intra-articular Botulinum Toxin Type A |
Botulinum Toxins Musculoskeletal Diseases Joint Diseases Arthritis |
Pain Botulinum Toxin Type A Arthralgia |
Anti-Dyskinesia Agents Therapeutic Uses Physiological Effects of Drugs Neuromuscular Agents |
Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions |