N/A N=21 Randomized Triple-blind Treatment

Randomized DB Controlled Trial of Botulinum Toxin A in Hemiplegic Shoulder Pain and Spasticity

Post-stroke Shoulder Pain and Spasticity

Bottom Line

View on ClinicalTrials.gov: NCT00661089 ↗

Enrolled (actual)

Serious AEs

23.8%

Results posted

Feb 2012

Primary outcome: Primary: Change in Pain Rating From Baseline to Four Weeks — -19.88; -18.64 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Botulinum Toxin Type A - OnabotulinumtoxinA (Drug); Placebo (Saline) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Shirley Ryan AbilityLab
Primary completion: Mar 2009

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	—	—

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.

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

View full record on ClinicalTrials.gov →

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.