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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00661089
First Posted: April 18, 2008
Last Update Posted: November 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Allergan
Information provided by (Responsible Party):
Christina Marciniak, Shirley Ryan AbilityLab
  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 - OnabotulinumtoxinA Drug: Placebo (Saline)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, 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 Christina Marciniak, Shirley Ryan AbilityLab:

Primary Outcome Measures:
  • Change in Pain Rating From Baseline to Four Weeks [ Time Frame: baseline and four weeks ]
    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 ]
    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 ]
  • Ability to Perform Hygiene Rating [ Time Frame: 2,4,12, and 16 weeks ]

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: Intramuscular OnabotulinumtoxinA
Injection of Botulinum Toxin type A - onabotulinumtoxinA into specified shoulder muscles at second visit
Drug: Botulinum Toxin Type A - OnabotulinumtoxinA
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: Intramuscular Placebo (Saline)
Injection of saline into specified shoulder muscles at Visit 2. Blind broken and subjects were offered study drug if initially in the placebo group, at week 12
Drug: Placebo (Saline)
Equivalent volume of saline without study drug injected into the pectoralis major. Teres major was also injected if tone noted in the 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00661089


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

Publications:
Responsible Party: Christina Marciniak, Principal Investigator, Shirley Ryan AbilityLab
ClinicalTrials.gov Identifier: NCT00661089     History of Changes
Other Study ID Numbers: 0335-006
First Submitted: April 16, 2008
First Posted: April 18, 2008
Results First Submitted: October 1, 2011
Results First Posted: February 6, 2012
Last Update Posted: November 20, 2017
Last Verified: October 2017

Keywords provided by Christina Marciniak, Shirley Ryan AbilityLab:
stroke
shoulder pain
spasticity

Additional relevant MeSH terms:
Muscle Spasticity
Shoulder Pain
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Arthralgia
Joint Diseases
Pain
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents