CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 28 enrolled
Drug / intervention
Lidocaine +3 moredrug
Likely dose
Triamcinolone + Lidocaine 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00597766
NCT00597766Phase 2Completed

Clinical Trials in Stroke Rehabilitation

MetroHealth Medical Center·interventional·Posted Jan 18, 2008·Updated Dec 13, 2017

In Brief

A Phase 2 clinical trial evaluating Lidocaine and Triamcinolone + Lidocaine for Shoulder Pain. Completed, enrolled 28 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsShoulder Pain
CountriesUnited States

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 18, 2008
Enrollment StartDec 1, 2007
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 18.5 years ago

Interventions

Lidocainedrug

One-time Screening/Eligibility Neer's Test: 5 cc of 2% lidocaine

Triamcinolone + Lidocainedrug

Low Dose -- One-time injection of 20 mg triamcinolone: 1.5 cc of normal saline, 0.5 cc of 40mg/cc of triamcinolone and 2 cc of 2% lidocaine

Triamcinolone + Lidocainedrug

Standard Dose -- One-time injection of 40 mg triamcinolone: 1 cc of normal saline, 1 cc of 40mg/cc of triamcinolone and 2 cc of 2% lidocaine

Triamcinolone + Lidocainedrug

High Dose -- One-time injection of 60 mg triamcinolone: 0.5 cc of normal saline, 1.5 cc of 40mg/cc of triamcinolone and 2 cc of 2% lidocaine