Post-stroke Shoulder Pain and Spasticity
Conditions
Keywords
stroke, shoulder pain, spasticity
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.
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. .
Interventions
DRUGBotulinum 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.
DRUGPlacebo (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.
Sponsors
Allergan
Shirley Ryan AbilityLab
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Rating From Baseline to Four Weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Disability Assessment Scale for Hygiene | 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 |
| Time to Don a Pull Over Shirt | 2,4,12, and 16 weeks | — |
| Ability to Perform Hygiene Rating | 2,4,12, and 16 weeks | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| onabotulinumtoxinA Injection Botulinum Toxin injected at second visit | 10 |
| Saline Injection Receives placebo injections following randomization (Saline).Delayed treatment group.
Blind broken and receives botulinum toxin at week 12 | 11 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | 1 subject withdrawal | 0 | 1 |
| Overall Study | death at 8 weeks due to new stroke | 0 | 1 |
Baseline characteristics
| Characteristic | Saline Injection | onabotulinumtoxinA Injection | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 8 Participants | 17 Participants |
| Age, Continuous | 58.9 years STANDARD_DEVIATION 10.3 | 60.2 years STANDARD_DEVIATION 7.8 | 60.00 years STANDARD_DEVIATION 8.95 |
| Region of Enrollment United States | 11 participants | 10 participants | 21 participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 10 | 2 / 11 |
| serious Total, serious adverse events | 1 / 10 | 4 / 11 |
Outcome results
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
Time frame: baseline and four weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Change in Pain Rating From Baseline to Four Weeks | -19.88 units on a scale |
| Botulinum Toxin Injection | Change in Pain Rating From Baseline to Four Weeks | -18.64 units on a scale |
Secondary
Ability to Perform Hygiene Rating
Time frame: 2,4,12, and 16 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
Time frame: baseline and 4 weeks post injection
Population: All enrolled subjects completed the baseline and for week post-injection measurements for this outcome
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Change in Disability Assessment Scale for Hygiene | 1.0 Score on a scale from 0-3 |
| Botulinum Toxin Injection | Change in Disability Assessment Scale for Hygiene | -1.0 Score on a scale from 0-3 |
Secondary
Time to Don a Pull Over Shirt
Time frame: 2,4,12, and 16 weeks