Subacromial Corticosteroid Injection for Hemiplegic Shoulder Pain
NCT ID: NCT00597766
Last Updated: 2017-12-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
28 participants
INTERVENTIONAL
2007-12-31
2012-02-29
Brief Summary
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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.
Detailed Description
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* Visit 1: Baseline information about demographics, past medical history, and inclusion/exclusion issues will be collected for study participants. Pertinent lab work will be performed to determine initial eligibility.
* Visit 2: All initially eligible participants also will undergo a test injection of lidocaine to localize the pain to the subacromial bursa (Neer's Test). A positive Neer's test is required to finalize eligibility for further participation. Participants who satisfy inclusion/exclusion criteria (including a positive Neer's test) will be randomized to high dose steroid, standard dose steroid, or low dose steroid via a computer generated random number table. The study participants and the observer will be blinded as to these groupings.
* After the initial Neer's test and randomization, participants will receive their assigned injection the same day. Participants then will be followed for an additional 12 weeks, including three follow-up visits (Visits 3-5). The total participation time in this study will be 13 weeks.
* The primary outcome measure will be the BPI 12. The BPI is a pain questionnaire, which assesses the "worst pain" in the previous 7 days. Secondary outcome measures also will be assessed together with BPI 12. There will be 3 additional secondary outcome measures, Fugl-Meyer Motor Assessment (a measure of poststroke motor impairment), pain free external rotation range of motion (ROM) and pain free abduction ROM.
* A blinded therapist will administer all outcome measures. The primary outcome will be assessed on a weekly basis via telephone (or in person during weeks of MetroHealth visits) starting on the day of Visit 1 and continuing to 12-weeks after steroid injection (i.e., for the 13 weeks of the subject's participation). The remaining secondary outcomes will be assessed in clinic visits at least every 4 weeks starting with Visit 2 (Visits 2-5).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Low Dose
Drug: Lidocaine (Neer's Test)
Drug: 20 mg Triamcinolone + Lidocaine
Lidocaine
One-time Screening/Eligibility Neer's Test: 5 cc of 2% lidocaine
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
Standard Dose
Drug: Lidocaine (Neer's Test)
Drug: 40 mg Triamcinolone + Lidocaine
Lidocaine
One-time Screening/Eligibility Neer's Test: 5 cc of 2% lidocaine
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
High Dose
Drug: Lidocaine (Neer's Test)
Drug: 60 mg Triamcinolone + Lidocaine
Lidocaine
One-time Screening/Eligibility Neer's Test: 5 cc of 2% lidocaine
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
Interventions
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Lidocaine
One-time Screening/Eligibility Neer's Test: 5 cc of 2% lidocaine
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
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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* \> 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
18 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Case Western Reserve University
OTHER
MetroHealth Medical Center
OTHER
Responsible Party
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John Chae, MD
Prof Vice Chair Physical Medicine and Rehabilitation
Principal Investigators
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John Chae, MD
Role: PRINCIPAL_INVESTIGATOR
MetroHealth Medical Center; Case Western Reserve University
Locations
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MetroHealth Medical Center
Cleveland, Ohio, United States
Countries
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Related Links
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The MetroHealth System - Clinical Trials