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Sponsors and Collaborators: |
Minneapolis Veterans Affairs Medical Center Allergan Minnesota Veterans Research Institute |
Information provided by: | Minneapolis Veterans Affairs Medical Center |
ClinicalTrials.gov Identifier: | NCT00211718 |
The purpose of this study is to determine whether intra-articular botulinum toxin type A is effective in the treatment of chronic joint pain.
Condition | Intervention | Phase |
Arthritis Shoulder Pain |
Drug: intra-articular botulinum toxin type a |
Phase III |
MedlinePlus related topics: | Botox |
ChemIDplus related topics: | Clostridium botulinum toxin Botulinum toxin A |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Intra-Articular Injection of Botulinum Toxin Type A for the Treatment of Shoulder Pain: A Randomized, Double Blinded, Placebo Controlled Trial |
Estimated Enrollment: | 40 |
Study Start Date: | July 2004 |
Estimated Study Completion Date: | June 2007 |
Chronic shoulder pain unresponsive to oral medications and intra-articular corticosteroids 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 botulinum toxin type a will be compared to intra-articular injection of placebo ( lidocaine then 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 | |||||
Contact: Maren l Mahowald, MD 612-467-4190 mahow001@umn.edu | |||||
Contact: Jasvinder A Singh, MD MPH 6124674190 Jasvinder.Singh@va.gov | |||||
Principal Investigator: Maren L Mahowald, MD | |||||
Sub-Investigator: Jasvinder A Singh, MD MPH | |||||
Sub-Investigator: Hollis E Krug, MD |
Minneapolis Veterans Affairs Medical Center |
Allergan |
Minnesota Veterans Research Institute |
Principal Investigator: | Maren L Mahowald, MD | Minneapolis VAMC |
Study ID Numbers: | IRB Protocol Number 03404B |
First Received: | September 14, 2005 |
Last Updated: | November 2, 2005 |
ClinicalTrials.gov Identifier: | NCT00211718 |
Health Authority: | United States: Food and Drug Administration |
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