Official Title: “Clinical Trials in Stroke Rehabilitation”

This is a double-blinded placebo-controlled 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, for shoulder pain in stroke survivors. A placebo control group also will be used. 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. control group which receives placebo injection to the subacromial space of the affected shoulder;

2. standard dose test group which receives a standard subacromial injection of 40mg of steroid (triamcinolone); or

3. high dose test group which receives a high dose subacromial injection of 60mg of the same steroid. Study participants will all rate their pain in weekly interviews.

Laboratory-based measures also will be administered every 4 weeks. Subjects will be followed for a total of 17 weeks.

The study will thus:

1. compare the effects of subacromial steroid injection versus placebo for reducing hemiplegic shoulder pain, and

2. compare the effects of standard versus high dose subacromial steroid injection for reducing hemiplegic shoulder pain.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study

Study Primary Completion Date: November 2011

- A total of 105 chronic stroke survivors with moderate to severe shoulder pain will be enrolled. Subjects will be enrolled in the study for 17 weeks. Subjects who complete the protocol will visit MetroHealth six times. - 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 placebo 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, there will be a baseline period of 4 weeks, after which participants will receive their assigned injection (Visit 3).

Participants then will be followed for an additional 12 weeks, including three follow-up visits (Visits 4-6). The total participation time in this study will be 17 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 BPI 13-15 ("least pain", "average pain", "pain right now") also will be assessed together with BPI 12. There will be 4 additional secondary outcome measures, BPI 23 (which assess the degree to which shoulder pain interferes with daily activities), Fugl-Meyer Motor Assessment (a measure of post-stroke 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 17 weeks of the subject's participation). Secondary measures BPI 13-15 will also be administered weekly along with BPI 12. The remaining secondary outcomes will be assessed in clinic visits every 4 weeks starting with Visit 2 (Visits 2-6).

Intervention(s) in this Clinical Trial

• Drug: Lidocaine
  • One-time Screening/Eligibility Neer's Test: 8-10 cc of 1% lidocaine
• Drug: Lidocaine
  • One-time Placebo: 2 cc of normal saline 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: 1/2 cc of normal saline, 1.5 cc of 40mg/cc of triamcinolone and 2 cc of 2% lidocaine

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: Placebo
• Active Comparator: Standard Dose
• Experimental: High Dose

Primary Measures

• BPI 12 (Brief Pain Inventory, Question 12) pain questionnaire
  • Time Frame: Weekly throughout the 17 weeks of the subject's participation (18 times)
    Safety Issue?: No

Secondary Measures

• BPI 13-15 (Brief Pain Inventory, Questions 13-15) pain questionnaire
  • Time Frame: Weekly throughout the 17 weeks of the subject's participation (18 times)
    Safety Issue?: No
• BPI 23 (Brief Pain Inventory, Question 23) pain questionnaire
  • Time Frame: Monthly throughout the 17 weeks of the subject's participation (5 times)
    Safety Issue?: No
• Fugl-Meyer Motor Assessment
  • Time Frame: Monthly throughout the 17 weeks of the subject's participation (5 times)
    Safety Issue?: No
• Pain free external rotation range of motion (ROM)
  • Time Frame: Monthly throughout the 17 weeks of the subject's participation (5 times)
    Safety Issue?: No
• Pain free abduction range of motion (ROM)
  • Time Frame: Monthly throughout the 17 weeks of the subject's participation (5 times)
    Safety Issue?: No

Inclusion Criteria:

• Age greater than 18
• Upper extremity hemiplegia due to hemorrhagic or nonhemorrhagic stroke
• No greater than 4/5 on manual muscle testing for the deltoid on the affected side if isolated movement is present
• Post-stroke duration at least 1 month, but less than 24 months
• Shoulder pain sustained for at least 1 month
• BPI 12 at least equal to 4 (pain scale)
• Willing and able to report pain and other conditions throughout the 4 month study period
• Positive Neer's test

Exclusion Criteria:

• Evidence of joint or overlying skin infection
• Taking more than 1 opioid or nonopioid analgesic for shoulder pain
• Regular intake of pain medications for any other chronic pain
• Steroid injections to the shoulder in the last 6 weeks
• Receiving physical or occupational therapies for shoulder pain
• 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)
• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute of Child Health and Human Development (NICHD)

Overall Clinical Trial Officials and Contacts

John Chae, MD Principal Investigator MetroHealth Medical Center; Case Western Reserve University  

Overall Contact: Peggy Maloney, RN 216-778-8563 mmaloney@metrohealth.org

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00597766

Study ID Number: K24HD054600

ClinicalTrials.gov Identifier: NCT00597766

Health Authority: United States: Federal Government