The purpose of this study is to determine whether intra-articular botulinum toxin type A is effective in the treatment of chronic joint pain.
Intra-Articular Injection of Botulinum Toxin Type A for the Treatment of Shoulder Pain: A Randomized, Double Blinded, Placebo Controlled Trial.
- Shoulder Pain
Treatment, Randomised, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study.
Primary Outcome Measures:
- Change in Pain Score
- Change in Joint Function
- Patient Global Assessment
Secondary Outcome Measures:
- Secondary Outcomes:
- Pain Relief
- Change in Disease specific Health Related QOL-WOOS
- Function improvement – Range of Motion, SPADI, Simple Shoulder tes
- Physican Assessment of Pain and Global Assessment of Improvement
- Safety Measure,
Eligibility & Criteria
- Ages Eligible for Study: 18 Years and older
- Genders Eligible for Study: Both
- Accepts Healthy Volunteers: No
- Male or female subjects, 18 years of age or older.
- Written informed consent and written authorisation 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.
- 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.
Maren L Mahowald, MD
Jasvinder A Singh, MD MPH
United States, 55417