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Shoulder Pain | Subacromial Corticosteroid Injection for Hemiplegic Shoulder Pain

Shoulder Pain research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - 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 Exclusion Criteria: - 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 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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Shoulder Pain

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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

Drug:Triamcinolone + LidocaineLow 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 + LidocaineStandard 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 + LidocaineHigh 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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Low DoseDrug: Lidocaine (Neer's Test) Drug: 20 mg Triamcinolone + Lidocaine

Standard DoseDrug: Lidocaine (Neer's Test) Drug: 40 mg Triamcinolone + Lidocaine

High DoseDrug: Lidocaine (Neer's Test) Drug: 60 mg Triamcinolone + Lidocaine

Study Status

Completed

Start Date: December 2007

Completed Date: February 2012

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: BPI 12 (Brief Pain Inventory, Question 12) Pain Questionnaire

Secondary Outcome: Fugl-Meyer Motor Assessment, Upper Limb Domain

Study sponsors, principal investigator, and references

Principal Investigator: John Chae, MD

Lead Sponsor: MetroHealth Medical Center

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

More information:https://clinicaltrials.gov/show/NCT00597766

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