Subacromial Corticosteroid Injection for Hemiplegic Shoulder Pain - Full Text View

Sponsored by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00597766

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 15 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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Clinical Trials in Stroke Rehabilitation

Resource links provided by NLM:

MedlinePlus related topics: Rehabilitation

Drug Information available for: Triamcinolone diacetate 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
Low Dose: Active Comparator	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
Standard Dose: Active Comparator	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
High Dose: Experimental	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

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 15 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 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, there will be a baseline period of 2 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 15 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 15 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 2-6).

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
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)
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	216-778-5347	mmaloney@metrohealth.org
Contact: Cathy Corrigan, RN	216-778-5347	ccorrigan@metrohealth.org

Locations

United States, Ohio
MetroHealth Medical Center	Recruiting
Cleveland, Ohio, United States, 44109
Contact: Peggy Maloney, RN 216-778-5347 mmaloney@metrohealth.org
Contact: Cathy Corrigan, RN 216-778-5347 ccorrigan@metrohealth.org
Principal Investigator: John Chae, MD

Sponsors and Collaborators

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

Investigators

Principal Investigator:

John Chae, MD

MetroHealth Medical Center; Case Western Reserve University

More Information

Additional Information:

The MetroHealth System - Clinical Trials This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	MetroHealth Medical Center; Case Western Reserve University ( John Chae, MD )
Study ID Numbers:	K24HD054600, K24HD054600
Study First Received:	January 9, 2008
Last Updated:	April 1, 2009
ClinicalTrials.gov Identifier:	NCT00597766 History of Changes
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

Study placed in the following topic categories:

Anti-Inflammatory Agents
Immunologic Factors
Cerebral Infarction
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Anesthetics
Pain
Hormones
Triamcinolone hexacetonide
Signs and Symptoms
Triamcinolone Acetonide
Musculoskeletal Diseases
Triamcinolone
Anti-Arrhythmia Agents

Arthralgia
Hemiplegia
Shoulder Pain
Joint Diseases
Stroke
Lidocaine
Central Nervous System Depressants
Triamcinolone diacetate
Cardiovascular Agents
Immunosuppressive Agents
Glucocorticoids
Anesthetics, Local
Peripheral Nervous System Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anesthetics
Pain
Hormones
Triamcinolone hexacetonide
Signs and Symptoms
Triamcinolone Acetonide
Musculoskeletal Diseases
Sensory System Agents
Therapeutic Uses
Triamcinolone

Anti-Arrhythmia Agents
Arthralgia
Shoulder Pain
Joint Diseases
Lidocaine
Central Nervous System Depressants
Enzyme Inhibitors
Triamcinolone diacetate
Cardiovascular Agents
Immunosuppressive Agents
Glucocorticoids
Anesthetics, Local
Pharmacologic Actions
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 11, 2009