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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
| Center for Veterans Research and Education | OTHER |
The purpose of this study is to determine whether intra-articular botulinum toxin type A is effective in the treatment of chronic joint pain.
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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intra-articular botulinum toxin type a | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| : Primary Outcomes: | ||
| Change in Pain Score | ||
| Change in Joint Function | ||
| Patient Global Assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcomes: | ||
| Pain Relief | ||
| Change in Health Status Quality of Life-SF36 |
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Inclusion Criteria:
• Male or female subjects, 18 years of age or older.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maren L Mahowald, MD | Contact | 6124674190 | mahow001@umn.edu | |
| Jasvinder A Singh, MD MPH | Contact | 6124674190 | Jasvinder.Singh@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Maren L Mahowald, MD | Minneapolis VAMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minneapolis VAMC | Recruiting | Minneapolis | Minnesota | 55417 | United States |
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| ID | Term |
|---|---|
| D001168 | Arthritis |
| D020069 | Shoulder Pain |
| D018771 | Arthralgia |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| 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, |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |