Arthritis, Shoulder Pain
Conditions
Keywords
shoulder pain, arthritis, intra-articular botulinum toxin a, joint pain
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 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).
Interventions
DRUGintra-articular botulinum toxin type a
Sponsors
Allergan
Center for Veterans Research and Education
Minneapolis Veterans Affairs Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| : Primary Outcomes: | — |
| Change in Pain Score | — |
| Change in Joint Function | — |
| Patient Global Assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| Function improvement - Range of Motion, SPADI, Simple Shoulder tes | — |
| Secondary Outcomes: | — |
| Safety Measure, | — |
| Physican Assessment of Pain and Global Assessment of Improvement | — |
| Pain Relief | — |
| Change in Health Status Quality of Life-SF36 | — |
| Change in Disease specific Health Related QOL-WOOS | — |
Countries
United States
Contacts
Primary ContactMaren L Mahowald, MD
Backup ContactJasvinder A Singh, MD MPH
Outcome results
None listed