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?
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
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
Start Date: December 2007
Completed Date: February 2012
Phase: Phase 2
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)