Trial Outcomes & Findings for Randomized DB Controlled Trial of Botulinum Toxin A in Hemiplegic Shoulder Pain and Spasticity (NCT NCT00661089)
NCT ID: NCT00661089
Last Updated: 2020-11-13
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
baseline and four weeks
Results posted on
2020-11-13
Participant Flow
Participant milestones
| Measure |
onabotulinumtoxinA Injection
Botulinum Toxin injected at second visit
|
Saline Injection
Receives placebo injections following randomization (Saline).Delayed treatment group.
Blind broken and receives botulinum toxin at week 12
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
|
Overall Study
COMPLETED
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
onabotulinumtoxinA Injection
Botulinum Toxin injected at second visit
|
Saline Injection
Receives placebo injections following randomization (Saline).Delayed treatment group.
Blind broken and receives botulinum toxin at week 12
|
|---|---|---|
|
Overall Study
1 subject withdrawal
|
0
|
1
|
|
Overall Study
death at 8 weeks due to new stroke
|
0
|
1
|
Baseline Characteristics
Randomized DB Controlled Trial of Botulinum Toxin A in Hemiplegic Shoulder Pain and Spasticity
Baseline characteristics by cohort
| Measure |
onabotulinumtoxinA Injection
n=10 Participants
Botulinum Toxin injected at second visit
|
Saline Injection
n=11 Participants
Receives placebo injections following randomization (Saline).Delayed treatment group.
Blind broken and receives botulinum toxin at week 12
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
60.2 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
58.9 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
60.00 years
STANDARD_DEVIATION 8.95 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and four weeksChange 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
Outcome measures
| Measure |
Placebo
n=11 Participants
Group recieved saline injections intramuscularly of equivalent volume
|
Botulinum Toxin Injection
n=10 Participants
Group received botulinum toxin type A (Botox) in the pectoralis and teres major muscles
|
|---|---|---|
|
Change in Pain Rating From Baseline to Four Weeks
|
-19.88 units on a scale
Interval -69.9 to 2.16
|
-18.64 units on a scale
Interval -29.73 to 2.14
|
SECONDARY outcome
Timeframe: baseline and 4 weeks post injectionPopulation: All enrolled subjects completed the baseline and for week post-injection measurements for this outcome
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
Outcome measures
| Measure |
Placebo
n=11 Participants
Group recieved saline injections intramuscularly of equivalent volume
|
Botulinum Toxin Injection
n=10 Participants
Group received botulinum toxin type A (Botox) in the pectoralis and teres major muscles
|
|---|---|---|
|
Change in Disability Assessment Scale for Hygiene
|
1.0 Score on a scale from 0-3
Interval 0.0 to 1.5
|
-1.0 Score on a scale from 0-3
Interval -1.0 to 0.0
|
SECONDARY outcome
Timeframe: 2,4,12, and 16 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2,4,12, and 16 weeksOutcome measures
Outcome data not reported
Adverse Events
onabotulinumtoxinA Injection
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Saline Injection
Serious events: 4 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
onabotulinumtoxinA Injection
n=10 participants at risk
Botulinum Toxin injected at second visit
|
Saline Injection
n=11 participants at risk
Receives placebo injections following randomization (Saline).Delayed treatment group.
Blind broken and receives botulinum toxin at week 12
|
|---|---|---|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/10 • From enrollment through 12 weeks post injection
|
18.2%
2/11 • Number of events 2 • From enrollment through 12 weeks post injection
|
|
Gastrointestinal disorders
Rectal bleeding
|
10.0%
1/10 • Number of events 1 • From enrollment through 12 weeks post injection
|
0.00%
0/11 • From enrollment through 12 weeks post injection
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/10 • From enrollment through 12 weeks post injection
|
9.1%
1/11 • Number of events 1 • From enrollment through 12 weeks post injection
|
|
Nervous system disorders
Seizure
|
0.00%
0/10 • From enrollment through 12 weeks post injection
|
9.1%
1/11 • Number of events 1 • From enrollment through 12 weeks post injection
|
|
Nervous system disorders
New Stroke
|
0.00%
0/10 • From enrollment through 12 weeks post injection
|
9.1%
1/11 • Number of events 1 • From enrollment through 12 weeks post injection
|
Other adverse events
| Measure |
onabotulinumtoxinA Injection
n=10 participants at risk
Botulinum Toxin injected at second visit
|
Saline Injection
n=11 participants at risk
Receives placebo injections following randomization (Saline).Delayed treatment group.
Blind broken and receives botulinum toxin at week 12
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
10.0%
1/10 • Number of events 1 • From enrollment through 12 weeks post injection
|
0.00%
0/11 • From enrollment through 12 weeks post injection
|
|
Renal and urinary disorders
Lower urinary tract infection
|
0.00%
0/10 • From enrollment through 12 weeks post injection
|
18.2%
2/11 • Number of events 2 • From enrollment through 12 weeks post injection
|
|
Psychiatric disorders
depression
|
10.0%
1/10 • Number of events 1 • From enrollment through 12 weeks post injection
|
0.00%
0/11 • From enrollment through 12 weeks post injection
|
Additional Information
Dr. Christina Marciniak
The Rehabilitation Institute of Chicago
Phone: 312-238-1000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place