drugset / Trial / NCT00597766

Subacromial Corticosteroid Injection for Hemiplegic Shoulder Pain

NCT00597766

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2007-12
Primary completion
2012-02
Completion
2012-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Triamcinolone Other / unclassified 20 mg
Subject Triamcinolone Other / unclassified 40 mg
Subject Triamcinolone Other / unclassified 60 mg
Background Lidocaine Other / unclassified 2 ml
Background Lidocaine Other / unclassified 5 ml

Indications