Subacromial Corticosteroid Injection for Hemiplegic Shoulder Pain

Completed · Phase 2

Conditions studied: Shoulder Pain

In brief

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.

Key facts

Study ID

NCT00597766

Run by

MetroHealth Medical Center

People needed

28

Starts

2007-12-01

Expected to finish

2012-02-01

Last updated by the study team

2017-12-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age greater than 18
• upper extremity hemiplegia due to hemorrhagic or nonhemorrhagic stroke
• ≤ 4/5 on manual muscle testing for the deltoid on the affected side if isolated movement is present
• post-stroke duration ≥ 1-mo, but < 24-mo
• shoulder pain sustained for ≥ 1-mo
• BPI 12 ≥ 4 (pain scale)
• willing and able to report pain and other conditions throughout the 4-mo study period
• positive Neer's test

You may not qualify if…

• evidence of joint or overlying skin infection
• > 2 opioid and/or nonopioid analgesic for shoulder pain (i.e., > 2 regardless of class)
• regular intake of pain medications for any other chronic pain
• steroid injections to the shoulder in the last 6-wks
• history of pre-stroke shoulder pain
• bleeding disorder
• for those on Coumadin, INR > 3.0
• history of allergies to lidocaine
• renal insufficiency (Creat > 2.0)
• both history of liver disease \& abnormal liver enzyme lab results
• poorly controlled diabetes (HbA1c > 7.0)
• medical instability
• cognitive deficits; In order to pass the cognitive exam, the participant must exhibit 3/3 registration and recall the same three objects in 30 minutes. The participant must also be able to correctly rank the following three levels of pain from highest to lowest: 1) falling from a 2-story building and breaking both ankles, 2) stubbing one's toe and 3) getting bitten by a mosquito.
• immunocompromised

Where it is running

• MetroHealth Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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