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

Shirley Ryan AbilityLab

Status: Completed

Conditions: Post-stroke Shoulder Pain and Spasticity

Treatments: Drug: Placebo (Saline); Drug: Botulinum Toxin Type A - OnabotulinumtoxinA

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00661089

0335-006

Details and patient eligibility

About

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.

Full 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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Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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21 participants in 2 patient groups

Intramuscular OnabotulinumtoxinA

Experimental group

Description:

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

Treatment:

Drug: Botulinum Toxin Type A - OnabotulinumtoxinA

Intramuscular Placebo (Saline)

Active Comparator group

Description:

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

Treatment:

Drug: Placebo (Saline)