Clinical trial NCT00661089: Randomized DB Controlled Trial of Botulinum Toxin A in Hemiplegic Shoulder Pain and Spasticity
Official title: "A Randomized Double-Blind Placebo-Controlled Trial of Botulinum Toxin Type A (BOTOX ) in the Treatment of Hemiplegic Shoulder Pain and Spasticity"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-stroke Shoulder Pain and Spasticity
Keywords: stroke
shoulder pain
spasticity
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2008-04-18
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed description: Subjects with shoulder pain and spasticity at the shoulder following a stroke resulting in hemiplegia are eligible for participation. Following an initial screening visit involving a history and physical examination, subjects will be entered in to the study if they have significant spasticity of shoulder internal rotation/adduction associated with pain rated at least a 4 on the VAS for pain. Subjects will also be given a cognitive screening in which they will be asked to rate pain in hypothetical situations.

Shoulder pain is a frequent complication following hemiplegic stroke, and may result in further disability. Spasticity is also a complication following stroke . Botulinum toxin is used in the treatment of post-stroke spasticity and may also have pain modulating effects. Participants in this study will be asked to make total of 6 visits over a period of approximately 13 weeks. Eligible subjects will be randomized to 100 to 200 units of botulinum toxin type injected into the pectoralis major at the second visit. If there is significant spasticity for shoulder extension, subjects will also receive injections into the teres major. Subjects will be followed up with assessments of pain, functioning, active and passive range of motion and depression following the initial injection. At the 12 weeks post injection visit, the blinding will be broken and subjects initially injected with placebo will be injected with the active drug. This will be done to give all subjects an opportunity to receive the active drug, as well as to assess the effects of any differences with delayed treatment. All subjects will return 4 weeks later to repeat the same assessments above. Subjects will be called at one year post study enrollment for repeat pain ratings and for information regarding subsequent treatments.

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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

Primary outcomes:
measure: Change in Pain Rating From Baseline to Four Weeks
timeFrame: baseline and four weeks
Secondary outcomes:
measure: Change in Disability Assessment Scale for Hygiene
timeFrame: baseline and 4 weeks post injection
measure: Time to Don a Pull Over Shirt
timeFrame: 2,4,12, and 16 weeks
measure: Ability to Perform Hygiene Rating
timeFrame: 2,4,12, and 16 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rehabilitation Institute of Chicago
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Christina Marciniak, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marciniak CM, Harvey RL, Gagnon CM, Duraski SA, Denby FA, McCarty S, Bravi LA, Polo KM, Fierstein KM. Does botulinum toxin type A decrease pain and lessen disability in hemiplegic survivors of stroke with shoulder pain and spasticity?: a randomized, double-blind, placebo-controlled trial. Am J Phys Med Rehabil. 2012 Dec;91(12):1007-19. doi: 10.1097/PHM.0b013e31826ecb02.