Status:
UNKNOWN
Intra-Articular Injection of Botulinum Toxin Type A for Shoulder Pain
Lead Sponsor:
Minneapolis Veterans Affairs Medical Center
Collaborating Sponsors:
Allergan
Center for Veterans Research and Education
Conditions:
Arthritis
Shoulder Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
Detailed Description
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...
Eligibility Criteria
Inclusion
- • 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
- 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.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
June 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00211718
Start Date
July 1 2004
End Date
June 1 2007
Last Update
November 3 2005
Active Locations (1)
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1
Minneapolis VAMC
Minneapolis, Minnesota, United States, 55417