Expired Study
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Minneapolis, Minnesota 55417


Purpose:

The purpose of this study is to determine whether intra-articular botulinum toxin type A is effective in the treatment of chronic joint pain.


Study summary:

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).


Criteria:

Inclusion Criteria: - • Male or female subjects, 18 years of age or older. - Written informed consent and written authorization for use or release of health and research study information have been obtained. - Subject has chronic Shoulder joint pain for more than 1 year. - Subject has pain >4.5 on numerical rating scale of 0 to 10. - Ability to follow study instructions and likely to complete all required visits. - Negative urine pregnancy test on the day of treatment prior to the administration of study medication (for females of childbearing potential if applicable) - Patients previously treated with intra-articular corticosteroid or viscosupplementation injections. - Patients with rheumatoid arthritis must have failed therapy with standard DMARDs (disease modifying anti-rheumatic drugs) and anti-TNF agents unless they have a contraindication to TNF blockers. - Patients who were considered not to be candidates for Shoulder joint replacement because of young age, abnormalities in periarticular tissues or because of co-morbid conditions. - Must be ambulatory and able to perform sit to stand. Exclusion Criteria: - Use of aminoglycoside antibiotics, curare-like agents, or other agents that might interfere with neuromuscular function. - Any medical condition that may put the subject at increased risk with exposure to botulinum neurotoxin including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amytrophic lateral sclerosis, any other disorder that might interfere with neuromuscular function or the presence of severe peripheral neuropathy. - Females who are pregnant, breast-feeding, 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. - Known allergy or sensitivity to any of the components in the study medication. - Evidence of recent alcohol or drug abuse. - Infection at injection site or systemic infection (postpone study entry until one week following recovery. - Known, uncontrolled serious systemic disease and/or life expectancy less than 12 months. - Concurrent participation in another investigational drug or device study or participation in the 30 days immediately prior to study enrollment. - Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study. - Patients whose pain is rated as less than 4.5 on a 10 point Numerical Pain Rating scale at the screening visit - Patients on coumadin or heparin because of increased risk of bleeding in the joint - Serious or unstable psychiatric disease or cognitive impairment that would limit evaluation of response to treatment.


NCT ID:

NCT00211718


Primary Contact:

Principal Investigator
Maren L Mahowald, MD
Minneapolis VAMC

Maren L Mahowald, MD
Phone: 6124674190
Email: mahow001@umn.edu


Backup Contact:

Email: Jasvinder.Singh@va.gov
Jasvinder A Singh, MD MPH
Phone: 6124674190


Location Contact:

Minneapolis, Minnesota 55417
United States

Maren l Mahowald, MD
Phone: 612-467-4190
Email: mahow001@umn.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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