Randomized DB Controlled Trial of Botulinum Toxin A in Hemiplegic Shoulder Pain and Spasticity
Information source: Rehabilitation Institute of Chicago
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post-Stroke Shoulder Pain and Spasticity
Intervention: Botulinum Toxin Type A (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Rehabilitation Institute of Chicago Official(s) and/or principal investigator(s):
Christina Marciniak, MD, Principal Investigator, Affiliation: Rehabilitation Institute of Chicago
Overall contact:
Christina M Marciniak, MD, Phone: 312-238-4740, Email: cmarciniak@ric.org
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.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Crossover Assignment
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.
.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Christina M Marciniak, MD, Phone: 312-238-4740, Email: cmarciniak@ric.org
Rehabilitation Institute of Chicago, Chicago, Illinois 60302, United States; Recruiting
Christina Marciniak, MD, Phone: 312-238-4740, Email: cmarciniak@ric.org
Christina M Marciniak, MD, Principal Investigator
Additional Information
Last updated: April 17, 2008
|
