Trial · NCT00597766
Subacromial Corticosteroid Injection for Hemiplegic Shoulder Pain
NCT00597766, Phase 2, Completed, MetroHealth Medical Center; results first posted 2017-12-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Subacromial Corticosteroid Injection for Hemiplegic Shoulder Pain. Trials, record NCT00597766. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00597766
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Subacromial Corticosteroid Injection for Hemiplegic Shoulder Pain
- NCT number
- NCT00597766
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 28 participants, actual
- Lead sponsor
- MetroHealth Medical Center
- Conditions
- Shoulder Pain
- Interventions
- Lidocaine, Triamcinolone + Lidocaine, Triamcinolone + Lidocaine, Triamcinolone + Lidocaine
- First posted
- 2008-01-18
- Last updated
- 2017-12-13
- Results first posted
- 2017-12-13
- Limitations and caveats
The study was powered to detect differnces between high-dose and placebo, and standard-dose and placebo. The trial was altered due to ethical concerns for placebo injection due to apparent effectiveness in the literature. Low dose was substituted.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | BPI 12 (Brief Pain Inventory, Question 12) Pain Questionnaire | Baseline, weeks 1, 2, 3, 4, 8, 12 (7 times) | Change in BPI-12, Worst pain in the last week on 0 (No Pain) to 10 (Worst Pain Possible) scale, from baseline to week 12. The data in the Outcome Measure data table represent the comparison of week 12 to baseline using least squares means from the linear mixed model, but data from all time points are included in the Statistical Analyses to arrive at the reported slopes/group x time interactions. |
| Secondary | Fugl-Meyer Motor Assessment, Upper Limb Domain | Baseline, weeks 4, 8, 12 (4 times) | Evaluates and measures recovery in post-stroke hemiplegic patients. Items are scored on a 3-point ordinal scale: 0 = cannot perform 1. = performs partially 2. = performs fully Scores for 33 motor function items are summed to arrive at a total score ranging from 0 to 66, where higher scores indicate greater motor function Differences baseline to week 12. The data in the Outcome Measure data table represent the comparison of week 12 to baseline using least squares means from the linear mixed model, but data from all time points are included in the Statistical Analyses to arrive at the reported slopes/group x time interactions. |
| Secondary | Pain Free External Rotation Range of Motion (ROM) | Baseline, weeks 4, 8, 12 (4 times) | Differences in least-mean squares (Degrees) from baseline to week 12. The data in the Outcome Measure data table represent the comparison of week 12 to baseline using least squares means from the linear mixed model, but data from all time points are included in the Statistical Analyses to arrive at the reported slopes/group x time interactions. |
| Secondary | Pain Free Abduction Range of Motion (ROM) | Baseline, weeks 4, 8, 12 (4 times) | Difference in least-squares means (Degrees) from baseline to week 12. The data in the Outcome Measure data table represent the comparison of week 12 to baseline using least squares means from the linear mixed model, but data from all time points are included in the Statistical Analyses to arrive at the reported slopes/group x time interactions. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | BPI 12 (Brief Pain Inventory, Question 12) Pain Questionnaire | Baseline, weeks 1, 2, 3, 4, 8, 12 (7 times) | We used available-cases. Missing values handled with maximum likelihood methods. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Fugl-Meyer Motor Assessment, Upper Limb Domain | Baseline, weeks 4, 8, 12 (4 times) | Available-case analysis with missing data handled by maximum likelihood methods. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Pain Free External Rotation Range of Motion (ROM) | Baseline, weeks 4, 8, 12 (4 times) | Available-case analysis with missing data handled by maximum likelihood methods. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Pain Free Abduction Range of Motion (ROM) | Baseline, weeks 4, 8, 12 (4 times) | Available-case analysis with missing data handled by maximum likelihood methods. | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| BPI 12 (Brief Pain Inventory, Question 12) Pain Questionnaire | 20mg Triamcinolone | -1.7 | 95% Confidence Interval -3.9 to 0.6 | units on a scale | |
| BPI 12 (Brief Pain Inventory, Question 12) Pain Questionnaire | 40mg Triamcinolone | -2.2 | 95% Confidence Interval -4.4 to 0.0 | units on a scale | |
| BPI 12 (Brief Pain Inventory, Question 12) Pain Questionnaire | 60mg Triamcinolone | -4.7 | 95% Confidence Interval -6.8 to -2.5 | units on a scale | |
| Fugl-Meyer Motor Assessment, Upper Limb Domain | 20mg Triamcinolone | 5.1 | 95% Confidence Interval -0.1 to 10.4 | units on a scale | |
| Fugl-Meyer Motor Assessment, Upper Limb Domain | 40mg Triamcinolone | 4.5 | 95% Confidence Interval -0.9 to 9.8 | units on a scale | |
| Fugl-Meyer Motor Assessment, Upper Limb Domain | 60mg Triamcinolone | 2.3 | 95% Confidence Interval -2.8 to 7.4 | units on a scale | |
| Pain Free External Rotation Range of Motion (ROM) | 20mg Triamcinolone | 26.7 | 95% Confidence Interval 8.2 to 45.1 | units on a scale | |
| Pain Free External Rotation Range of Motion (ROM) | 40mg Triamcinolone | 12.7 | 95% Confidence Interval -6.0 to 31.4 | units on a scale | |
| Pain Free External Rotation Range of Motion (ROM) | 60mg Triamcinolone | 10.3 | 95% Confidence Interval -7.5 to 28.1 | units on a scale | |
| Pain Free Abduction Range of Motion (ROM) | 20mg Triamcinolone | 33.3 | 95% Confidence Interval 7.9 to 58.7 | units on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Enrolled | STARTED | 20mg Triamcinolone | 9 | |
| Enrolled | STARTED | 40mg Triamcinolone | 9 | |
| Enrolled | STARTED | 60mg Triamcinolone | 10 | |
| Enrolled | COMPLETED | 20mg Triamcinolone | 9 | |
| Enrolled | COMPLETED | 40mg Triamcinolone | 9 | |
| Enrolled | COMPLETED | 60mg Triamcinolone | 10 | |
| Enrolled | NOT COMPLETED | 20mg Triamcinolone | 0 | |
| Enrolled | NOT COMPLETED | 40mg Triamcinolone | 0 | |
| Enrolled | NOT COMPLETED | 60mg Triamcinolone | 0 | |
| Follow-up 1, Week 4 | STARTED | 20mg Triamcinolone | 9 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events3
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 |
|---|---|---|---|---|---|---|
| serious | GI Illness requiring hospitalization | Gastrointestinal disorders | 20mg Triamcinolone | 0 | 9 | 0 |
| serious | GI Illness requiring hospitalization | Gastrointestinal disorders | 40mg Triamcinolone | 0 | 9 | 0 |
| serious | GI Illness requiring hospitalization | Gastrointestinal disorders | 60mg Triamcinolone | 1 | 10 | 1 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 20mg Triamcinolone | ||
| Total, all-cause mortality | 40mg Triamcinolone | ||
| Total, all-cause mortality | 60mg Triamcinolone | ||
| Total, other adverse events | 20mg Triamcinolone | 0 | 9 |
| Total, other adverse events | 40mg Triamcinolone | 0 | 9 |
| Total, other adverse events | 60mg Triamcinolone | 0 | 10 |
| Total, serious adverse events | 20mg Triamcinolone | 0 | 9 |
| Total, serious adverse events | 40mg Triamcinolone | 0 | 9 |
| Total, serious adverse events | 60mg Triamcinolone | 1 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| K24HD054600 | Clinical Trials in Stroke Rehabilitation | CHAE, JOHN | CASE WESTERN RESERVE UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2007 to 2011 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00597766
GET https://conductscience.org/api/trials/v1/NCT00597766/flow?page=2