Intra-Articular Injection of Botulinum Toxin Type A for Shoulder Pain

• Status: Unknown status
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Minneapolis Veterans Affairs Medical Center
• Collaborators: Allergan; Center for Veterans Research and Education; Minnesota Veterans Medical Research and Education Foundation
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

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.