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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 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.

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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.

Conditions Studied

Shoulder Pain

Interventions

  • DRUG Lidocaine
  • DRUG Triamcinolone + Lidocaine

Study Locations (1)

Ohio

  • MetroHealth Medical Center - Cleveland

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2007-12
Est. Completion 2012-02
Phase Phase 2

Sponsor

MetroHealth Medical Center

76 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00597766

The ClinicalTrials.gov registry entry for NCT00597766 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 100-participant average among 27 other Shoulder Pain trials with a reported enrollment target (72% lower). The listed sponsor is MetroHealth Medical Center, which has 76 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.