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NCT00597766 · ClinicalTrials.gov registry record · Phase 2
Subacromial Corticosteroid Injection for Hemiplegic Shoulder Pain
A Phase 2 study of Shoulder Pain, sponsored by MetroHealth Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT00597766: Completed Phase 2 study of Shoulder Pain, sponsored by MetroHealth Medical Center.
NCT00597766 is a Phase 2 study of Shoulder Pain that has completed, run by MetroHealth Medical Center. The registered enrollment target is 28 participants, below the 100-participant average among 27 other Shoulder Pain trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00597766, a Phase 2 study of Shoulder Pain, has completed, sponsored by MetroHealth Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a double-blinded study of subacromial corticosteroid injection (steroid injection to the shoulder) to treat shoulder pain in the paralyzed (hemiplegic) shoulder of chronic stroke survivors. This study is designed to evaluate pain relief of a standard steroid injection treatment, compared to a high dose treatment and a low dose treatment, for shoulder pain in stroke survivors. A total of 105 chronic stroke survivors with moderate to severe shoulder pain will be enrolled. All eligible participants will undergo an initial test injection to localize pain to the subacromial space. If this turns out to be positive, the subjects will be randomly assigned to one of three groups: 1. low dose group which receives 20mg of steroid (triamcinolone) injection to the subacromial space of the affected shoulder; 2. standard dose group which receives a standard 40mg of steroid (triamcinolone) injection to the subacromial space of the affected shoulder; or 3. high dose group which receives 60mg of steroid (triamcinolone) injection to the subacromial space of the affected shoulder. Study participants will all rate their pain in interviews (Baseline, weeks 1, 2, 3, 4, 8, 12 (7 times) and in laboratory-based measures that will be administered at baseline, weeks 4, 8, 12 (4 times). Subjects will be followed for a total of 13 weeks. The study will thus characterize the dose response of triamcinolone for the treatment of hemiplegic shoulder pain.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Lidocaine
- DRUG Triamcinolone + Lidocaine
Study Locations (1)
Ohio
- MetroHealth Medical Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2007-12 |
| Est. Completion | 2012-02 |
| Phase | Phase 2 |
What the finished NCT00597766 record still lists
NCT00597766 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 100-participant average among 27 other Shoulder Pain trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Shoulder Pain appearing as the primary indexed condition, and to 2 interventions - of which Lidocaine is the first listed.
NCT00597766 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT00597766 about?
NCT00597766 is a clinical study titled "Subacromial Corticosteroid Injection for Hemiplegic Shoulder Pain". This is a double-blinded study of subacromial corticosteroid injection (steroid injection to the shoulder) to treat shoulder pain in the paralyzed (hemiplegic) shoulder of chronic stroke survivors. This study is designed to evaluate pain relief of a standard steroid injection treatment, compared to ...
What is the current status of trial NCT00597766?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2007-12. Estimated completion is 2012-02.
What conditions does trial NCT00597766 study?
This clinical trial studies the following conditions: Shoulder Pain.
What interventions are being tested in trial NCT00597766?
The interventions under investigation include: Lidocaine (DRUG), Triamcinolone + Lidocaine (DRUG).
Who is sponsoring clinical trial NCT00597766?
This trial is sponsored by MetroHealth Medical Center, which has 76 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00597766 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Shoulder Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00597766's enrollment target sits among peer trials
28 23rd of 27 higher than 5 of 27 other Shoulder Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Shoulder Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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