Subacromial Corticosteroid Injection for Hemiplegic Shoulder Pain

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

• Shoulder Pain

Interventions

DRUG

Lidocaine

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

DRUG

Triamcinolone + Lidocaine

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

DRUG

Triamcinolone + Lidocaine

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

DRUG

Triamcinolone + Lidocaine

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

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• Case Western Reserve University

  collaborator OTHER

• MetroHealth Medical Center

  lead OTHER

Principal Investigators

• John Chae, MD · MetroHealth Medical Center; Case Western Reserve University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-12-31

Primary Completion

2012-02-29

Completion

2012-02-29

Countries

• United States

Study Locations