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

Post-stroke Shoulder Pain and Spasticity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00661089
• Other study ID #: 0335-006
• Status: Completed
• Phase: N/A
• Start date: September 2003
• Est. completion date: February 2010

Study information

• Verified date: October 2020
• Source: Shirley Ryan AbilityLab
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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. .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: February 2010
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Muscle Spasticity
• Post-stroke Shoulder Pain and Spasticity
• Shoulder Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Rehabilitation Institute of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Shirley Ryan AbilityLab	Allergan

Country where clinical trial is conducted

United States, 

References & 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, doubl — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Time to Don a Pull Over Shirt		2,4,12, and 16 weeks
Secondary	Ability to Perform Hygiene Rating		2,4,12, and 16 weeks