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

This study has been completed.
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Christina Marciniak, Rehabilitation Institute of Chicago
ClinicalTrials.gov Identifier:
NCT00661089
First received: April 16, 2008
Last updated: November 29, 2012
Last verified: October 2012
  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 - OnabotulinuntoxinA

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: "A Randomized Double-Blind Placebo-Controlled Trial of Botulinum Toxin Type A (BOTOX ) in the Treatment of Hemiplegic Shoulder Pain and Spasticity"

Resource links provided by NLM:


Further study details as provided by Rehabilitation Institute of Chicago:

Primary Outcome Measures:
  • Change in Pain Rating From Baseline to Four Weeks [ Time Frame: baseline and four weeks ] [ Designated as safety issue: No ]
    Change scores from patient ratings VAS on mm scale for worst pain, averaged over a week for ratings performed at baseline and week four. Scale range 0-100 mm. 0= No pain, 100= worst pain


Secondary Outcome Measures:
  • Change in Disability Assessment Scale for Hygiene [ Time Frame: baseline and 4 weeks post injection ] [ Designated as safety issue: No ]
    Subject rating of scores on the Disability Assessment Scale Range 0-3, 0= no disability, 3= severe disability

  • Time to Don a Pull Over Shirt [ Time Frame: 2,4,12, and 16 weeks ] [ Designated as safety issue: No ]
  • Ability to Perform Hygiene Rating [ Time Frame: 2,4,12, and 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: September 2003
Study Completion Date: February 2010
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Botulinum Toxin injected at second visit
Drug: Botulinum Toxin Type A - OnabotulinuntoxinA
100-200 units injected into the pectoralis major. The teres major may also be injected if tone is noted in shoulder extensors.
Other Name: BOTOX
Active Comparator: 2

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

Blind broken and receives botulinum toxin at week 12

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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661089

Locations
United States, Illinois
Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60302
Sponsors and Collaborators
Rehabilitation Institute of Chicago
Allergan
Investigators
Principal Investigator: Christina Marciniak, MD Rehabilitation Institute of Chicago
  More Information

Publications:
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 Rehabil2012;91.in press

Responsible Party: Christina Marciniak, Principal Investigator, Rehabilitation Institute of Chicago
ClinicalTrials.gov Identifier: NCT00661089     History of Changes
Other Study ID Numbers: 0335-006
Study First Received: April 16, 2008
Results First Received: October 1, 2011
Last Updated: November 29, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Muscle Spasticity
Shoulder Pain
Arthralgia
Joint Diseases
Muscle Hypertonia
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Pain
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014