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

NCT00661089 | Completed Results

• 1 other identifier: 0335-006
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-stroke Shoulder Pain and Spasticity

Keywords

stroke; shoulder pain; spasticity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Disability Assessment Scale for Hygiene

  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

Study Arms (2)

Intramuscular OnabotulinumtoxinA

EXPERIMENTAL

Injection of Botulinum Toxin type A - onabotulinumtoxinA into specified shoulder muscles at second visit

Drug: Botulinum Toxin Type A - OnabotulinumtoxinA

Intramuscular Placebo (Saline)

ACTIVE COMPARATOR

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)

Interventions

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.

Also known as: BOTOX

Intramuscular OnabotulinumtoxinA

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.

Intramuscular Placebo (Saline)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Post stroke greater than 2 months
• Shoulder pain despite PT/OT interventions
• Weight greater than 88 lbs
• Stable medically
• Spasticity

You may not qualify if:

• Myasthenia gravis or other medical conditions that preclude use of botulinum toxin
• Pregnancy
• Infection or dermatologic conditions at the injection site

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• Allergan: collaborator

Study Sites (1)

Rehabilitation Institute of Chicago

Chicago, Illinois, 60302, United States

Location

Related Publications (1)

• 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.

  PMID: 23064478 RESULT

MeSH Terms

Conditions

Muscle Spasticity; Stroke; Shoulder Pain

Interventions

Botulinum Toxins, Type A; Sodium Chloride

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arthralgia; Joint Diseases; Pain

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

Best and Worst pain collected, which may have limited the ability to detect overall pain. At the time of enrollment, subjects were on average very impaired by the Fugl-Meyer Scale measure, and pain on average had been present for several years.

Results Point of Contact

• Title: Dr. Christina Marciniak
• Organization: The Rehabilitation Institute of Chicago

cmarciniak@ric.org

312-238-1000

Study Officials

• Christina Marciniak, MD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 16, 2008
• First Posted: April 18, 2008
• Study Start: September 1, 2003
• Primary Completion: March 1, 2009
• Study Completion: February 1, 2010
• Last Updated: November 13, 2020
• Results First Posted: February 6, 2012

Record last verified: 2020-10

Locations

US (1)