Subacromial Corticosteroid Injection for Hemiplegic Shoulder Pain
This study is currently recruiting participants.
Verified December 2011 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor:
Information provided by (Responsible Party):
John Chae, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT00597766
First received: January 9, 2008
Last updated: December 22, 2011
Last verified: December 2011
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Purpose
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:
- low dose group which receives 20mg of steroid (triamcinolone) injection to the subacromial space of the affected shoulder;
- standard dose group which receives a standard 40mg of steroid (triamcinolone) injection to the subacromial space of the affected shoulder; or
- 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 weekly interviews. Laboratory-based measures also will be administered every 4 weeks. 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Shoulder Pain |
Drug: Lidocaine Drug: Triamcinolone + Lidocaine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Clinical Trials in Stroke Rehabilitation |
Resource links provided by NLM:
Drug Information available for:
Triamcinolone diacetate
Lidocaine hydrochloride
Triamcinolone acetonide
Triamcinolone
Lidocaine
Triamcinolone hexacetonide
U.S. FDA Resources
Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Primary Outcome Measures:
- BPI 12 (Brief Pain Inventory, Question 12) pain questionnaire [ Time Frame: Weekly throughout the 15 weeks of the subject's participation (16 times) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- BPI 13-15 (Brief Pain Inventory, Questions 13-15) pain questionnaire [ Time Frame: Weekly throughout the 15 weeks of the subject's participation (16 times) ] [ Designated as safety issue: No ]
- BPI 23 (Brief Pain Inventory, Question 23) pain questionnaire [ Time Frame: Monthly throughout the 15 weeks of the subject's participation (5 times) ] [ Designated as safety issue: No ]
- Fugl-Meyer Motor Assessment [ Time Frame: Monthly throughout the 15 weeks of the subject's participation (5 times) ] [ Designated as safety issue: No ]
- Pain free external rotation range of motion (ROM) [ Time Frame: Monthly throughout the 15 weeks of the subject's participation (5 times) ] [ Designated as safety issue: No ]
- Pain free abduction range of motion (ROM) [ Time Frame: Monthly throughout the 15 weeks of the subject's participation (5 times) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 105 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | February 2012 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Low Dose |
Drug: Lidocaine
One-time Screening/Eligibility Neer's Test: 5 cc of 2% lidocaine
Drug: 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
Other Name: Kenalog = Triamcinolone
|
| Active Comparator: Standard Dose |
Drug: Lidocaine
One-time Screening/Eligibility Neer's Test: 5 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
Other Name: Kenalog = Triamcinolone
|
| Experimental: High Dose |
Drug: Lidocaine
One-time Screening/Eligibility Neer's Test: 5 cc of 2% lidocaine
Drug: 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 Name: Kenalog = Triamcinolone
|
Detailed Description:
- A total of 105 chronic stroke survivors with moderate to severe shoulder pain will be enrolled. Subjects will be enrolled in the study for 13 weeks. Subjects who complete the protocol will visit MetroHealth five 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 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 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 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). Secondary measures BPI 13-15 will also be administered weekly along with BPI 12. The remaining secondary outcomes will be assessed in clinic visits at least every 4 weeks starting with Visit 2 (Visits 2-5).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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 & 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00597766
Contacts
| Contact: Peggy Maloney, RN | 216-778-8563 | mmaloney@metrohealth.org |
Locations
| United States, Ohio | |
| MetroHealth Medical Center | Recruiting |
| Cleveland, Ohio, United States, 44109 | |
| Contact: Peggy Maloney, RN 216-778-8563 mmaloney@metrohealth.org | |
| Principal Investigator: John Chae, MD | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | John Chae, MD | MetroHealth Medical Center; Case Western Reserve University |
More Information
Additional Information:
No publications provided
| Responsible Party: | John Chae, Prof Vice Chair Physical Medicine and Rehabilitation, Case Western Reserve University |
| ClinicalTrials.gov Identifier: | NCT00597766 History of Changes |
| Other Study ID Numbers: | K24HD054600 |
| Study First Received: | January 9, 2008 |
| Last Updated: | December 22, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
CVA Hemiplegia Hemiplegic shoulder pain Subacromial steroid injection |
Additional relevant MeSH terms:
|
Shoulder Pain Arthralgia Joint Diseases Musculoskeletal Diseases Pain Signs and Symptoms Lidocaine Triamcinolone hexacetonide Triamcinolone Triamcinolone Acetonide Triamcinolone diacetate Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs |
Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Anti-Arrhythmia Agents Cardiovascular Agents Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Immunosuppressive Agents Immunologic Factors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013