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Completed

NCT Number: NCT00661089

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

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.

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Key information

Conditions

Post-stroke Shoulder Pain and Spasticity Arthralgia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Joint Diseases Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pain Pathological Conditions, Signs and Symptoms Shoulder Pain Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rehabilitation Institute of Chicago

Chicago, Illinois, 60302, United States

About this study

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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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum Toxin Type A - OnabotulinumtoxinA

Drug

100-200 units injected into the pectoralis major. The teres major may also be injected if tone is noted in shoulder extensors.

Other names: BOTOX

Placebo (saline)

Drug

Equivalent volume of saline without study drug injected into the pectoralis major. Teres major was also injected if tone noted in the shoulder extensors.

Primary outcomes

  1. Change in Pain Rating From Baseline to Four Weeks

    Time frame: baseline and four weeks

    Change scores from patient ratings on the Visual Analogue Scale on 101 mm scale for worst pain, averaged over a week. Ratings performed at baseline and week four. Scale range 0-100 mm. Minimum value 0= No pain, Maximum value 100= worst pain Higher score indicates worse outcome

Secondary outcomes

  1. 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, Minimum value 0= no disability, Maximum value 3= severe disability Higher Score indicates worse outcome

  2. Time to Don a Pull Over Shirt

    Time frame: 2,4,12, and 16 weeks

  3. Ability to Perform Hygiene Rating

    Time frame: 2,4,12, and 16 weeks

Sponsors and collaborators

Lead sponsor

Shirley Ryan AbilityLab

Other

Collaborators

  • Allergan

Registry information

Official study title

"A Randomized Double-Blind Placebo-Controlled Trial of Botulinum Toxin Type A (BOTOX ) in the Treatment of Hemiplegic Shoulder Pain and Spasticity"

Important dates

Study start
2003
Primary completion
2009
Study completion
2010
First posted
Apr 18, 2008
Registry last updated
Nov 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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