Trial · NCT00661089
Randomized DB Controlled Trial of Botulinum Toxin A in Hemiplegic Shoulder Pain and Spasticity
NCT00661089, Not applicable, Completed, Shirley Ryan AbilityLab; results first posted 2012-02-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Randomized DB Controlled Trial of Botulinum Toxin A in Hemiplegic Shoulder Pain and Spasticity. Trials, record NCT00661089. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00661089
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized DB Controlled Trial of Botulinum Toxin A in Hemiplegic Shoulder Pain and Spasticity
- NCT number
- NCT00661089
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 21 participants, actual
- Lead sponsor
- Shirley Ryan AbilityLab
- Conditions
- Post-stroke Shoulder Pain and Spasticity
- Interventions
- Botulinum Toxin Type A - OnabotulinumtoxinA, Placebo (Saline)
- First posted
- 2008-04-18
- Last updated
- 2020-11-13
- Results first posted
- 2012-02-06
- 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.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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 |
| 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 |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Change in Disability Assessment Scale for Hygiene | baseline and 4 weeks post injection | All enrolled subjects completed the baseline and for week post-injection measurements for this outcome | Score on a scale from 0-3 | MEDIAN |
| 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 | |||
| PRIMARY | Change in Pain Rating From Baseline to Four Weeks | baseline and four weeks | units on a scale | MEDIAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Disability Assessment Scale for Hygiene | Placebo | 1.0 | Inter-Quartile Range 0 to 1.5 | Score on a scale from 0-3 | |
| Change in Disability Assessment Scale for Hygiene | Botulinum Toxin Injection | -1.0 | Inter-Quartile Range -1.0 to 0 | Score on a scale from 0-3 | |
| Change in Pain Rating From Baseline to Four Weeks | Placebo | -19.88 | Inter-Quartile Range -69.90 to 2.16 | units on a scale | |
| Change in Pain Rating From Baseline to Four Weeks | Botulinum Toxin Injection | -18.64 | Inter-Quartile Range -29.73 to 2.14 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | onabotulinumtoxinA Injection | 10 | |
| Overall Study | STARTED | Saline Injection | 11 | |
| Overall Study | COMPLETED | onabotulinumtoxinA Injection | 10 | |
| Overall Study | COMPLETED | Saline Injection | 9 | |
| Overall Study | NOT COMPLETED | onabotulinumtoxinA Injection | 0 | |
| Overall Study | NOT COMPLETED | Saline Injection | 2 |
Source ClinicalTrials.gov
Adverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bronchitis | Respiratory, thoracic and mediastinal disorders | onabotulinumtoxinA Injection | 1 | 10 | 1 |
| other | Bronchitis | Respiratory, thoracic and mediastinal disorders | Saline Injection | 0 | 11 | 0 |
| other | Lower urinary tract infection | Renal and urinary disorders | onabotulinumtoxinA Injection | 0 | 10 | 0 |
| other | Lower urinary tract infection | Renal and urinary disorders | Saline Injection | 2 | 11 | 2 |
| other | depression | Psychiatric disorders | onabotulinumtoxinA Injection | 1 | 10 | 1 |
| other | depression | Psychiatric disorders | Saline Injection | 0 | 11 | 0 |
| serious | Urinary tract infection | Renal and urinary disorders | onabotulinumtoxinA Injection | 0 | 10 | 0 |
| serious | Urinary tract infection | Renal and urinary disorders | Saline Injection | 2 | 11 | 2 |
| serious | Rectal bleeding | Gastrointestinal disorders | onabotulinumtoxinA Injection | 1 | 10 | 1 |
| serious | Rectal bleeding | Gastrointestinal disorders | Saline Injection | 0 | 11 | 0 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | onabotulinumtoxinA Injection | ||
| Total, all-cause mortality | Saline Injection | ||
| Total, other adverse events | onabotulinumtoxinA Injection | 1 | 10 |
| Total, other adverse events | Saline Injection | 2 | 11 |
| Total, serious adverse events | onabotulinumtoxinA Injection | 1 | 10 |
| Total, serious adverse events | Saline Injection | 4 | 11 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23064478 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| onabotulinumtoxinA Injection vs Saline Injection: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00661089
GET https://conductscience.org/api/trials/v1/NCT00661089/registered