N/A
Completed N=21
Randomized DB Controlled Trial of Botulinum Toxin A in Hemiplegic Shoulder Pain and Spasticity
Post-stroke Shoulder Pain and Spasticity
Source: ClinicalTrials.gov NCT00661089 ↗
Enrolled (actual)
21
Serious AEs
23.8%
Results posted
Feb 2012
Primary outcomePrimary: Change in Pain Rating From Baseline to Four Weeks — -19.88; -18.64 units on a scale
Summary
The purpose of this study is to evaluate whether botulinum toxin type A injected into muscles around the shoulder is effective in treating shoulder pain and improving function in patients with shoulder pain and involuntary muscle tightness after a stroke.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Rating From Baseline to Four Weeks |
-19.88; -18.64 | — |
| SECONDARY Change in Disability Assessment Scale for Hygiene |
1.0; -1.0 | — |
| SECONDARY Time to Don a Pull Over Shirt |
— | — |
| SECONDARY Ability to Perform Hygiene Rating |
— | — |
Eligibility Criteria
Inclusion Criteria
- Post stroke greater than 2 months
- Shoulder pain despite PT/OT interventions
- Weight greater than 88 lbs
- Stable medically
- Spasticity
Exclusion Criteria
- Myasthenia gravis or other medical conditions that preclude use of botulinum toxin
- Pregnancy
- Infection or dermatologic conditions at the injection site
Data sourced from ClinicalTrials.gov (NCT00661089). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.