Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Randomized DB Controlled Trial of Botulinum Toxin A in Hemiplegic Shoulder Pain and Spasticity
This study is currently recruiting participants.
Verified by Rehabilitation Institute of Chicago, April 2008
Sponsored by: Rehabilitation Institute of Chicago
Information provided by: Rehabilitation Institute of Chicago
ClinicalTrials.gov Identifier: NCT00661089
  Purpose

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.


Condition Intervention
Post-Stroke Shoulder Pain and Spasticity
Drug: Botulinum Toxin Type A

MedlinePlus related topics: Botox Rehabilitation
Drug Information available for: Clostridium botulinum toxin Botulinum toxin A
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Crossover Assignment
Official Title: "A Randomized Double-Blind Placebo-Controlled Trial of Botulinum Toxin Type A (BOTOX ) in the Treatment of Hemiplegic Shoulder Pain and Spasticity"

Further study details as provided by Rehabilitation Institute of Chicago:

Estimated Enrollment: 30
Arms Assigned Interventions
1: Experimental
Botulinum Toxin injected at second visit
Drug: Botulinum Toxin Type A
100-200 units injected into the pectoralis major. The teres major may also be injected if tone is noted in shoulder extensors.
2: Active Comparator

Receives placebo injections following randomization (Saline).Delayed treatement group.

Blind broken and receives botulinum toxin at week 12

Drug: Botulinum Toxin Type A
100-200 units injected into the pectoralis major. The teres major may also be injected if tone is noted in shoulder extensors.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00661089

Contacts
Contact: Christina M Marciniak, MD 312-238-4740 cmarciniak@ric.org
Contact: Sylvia Duraski, RN 312-238-1000 sduraski@ric.org

Locations
United States, Illinois
Rehabilitation Institute of Chicago Recruiting
Chicago, Illinois, United States, 60302
Contact: Christina Marciniak, MD     312-238-4740     cmarciniak@ric.org    
Principal Investigator: Christina M Marciniak, MD            
Sponsors and Collaborators
Rehabilitation Institute of Chicago
Investigators
Principal Investigator: Christina Marciniak, MD Rehabilitation Institute of Chicago
  More Information

Responsible Party: Rehabilitation Institute of Chicago ( Christina Marciniak )
Study ID Numbers: 0335-006
Study First Received: April 16, 2008
Last Updated: April 17, 2008
ClinicalTrials.gov Identifier: NCT00661089  
Health Authority: United States: Institutional Review Board

Keywords provided by Rehabilitation Institute of Chicago:
stroke
shoulder pain
spasticity

Study placed in the following topic categories:
Cerebral Infarction
Shoulder Pain
Joint Diseases
Stroke
Pain
Signs and Symptoms
Muscle Spasticity
Botulinum Toxins
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neurologic Manifestations
Botulinum Toxin Type A
Arthralgia

Additional relevant MeSH terms:
Neuromuscular Manifestations
Anti-Dyskinesia Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009