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

"A Randomized Double-Blind Placebo-Controlled Trial of Botulinum Toxin Type A (BOTOX ) in the Treatment of 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.

Study Overview

• Status: Completed
• Conditions: Post-stroke Shoulder Pain and Spasticity
• Intervention / Treatment: Drug: Botulinum Toxin Type A - OnabotulinumtoxinA; Drug: Placebo (Saline)

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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• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60302
      • Rehabilitation Institute of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Rating From Baseline to 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	baseline and four weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Disability Assessment Scale for Hygiene	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	baseline and 4 weeks post injection
Time to Don a Pull Over Shirt		2,4,12, and 16 weeks
Ability to Perform Hygiene Rating		2,4,12, and 16 weeks

Collaborators and Investigators

• Sponsor: Shirley Ryan AbilityLab
• Collaborators: Allergan
• Investigators: Principal Investigator: Christina Marciniak, MD, Shirley Ryan AbilityLab

Publications and helpful links

General 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 Rehabil. 2012 Dec;91(12):1007-19. doi: 10.1097/PHM.0b013e31826ecb02.

Study record dates

Study Major Dates

• Study Start: September 1, 2003
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: April 16, 2008
• First Submitted That Met QC Criteria: April 17, 2008
• First Posted (Estimate): April 18, 2008

Study Record Updates

• Last Update Posted (Actual): November 13, 2020
• Last Update Submitted That Met QC Criteria: October 19, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: stroke; spasticity; shoulder pain
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Arthralgia; Muscle Hypertonia; Shoulder Pain; Muscle Spasticity; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: 0335-006