Subacromial Corticosteroid Injection for Hemiplegic Shoulder Pain

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ClinicalTrials.gov Identifier: NCT00597766

Recruitment Status : Completed

First Posted : January 18, 2008

Results First Posted : December 13, 2017

Last Update Posted : December 13, 2017

Sponsor:

Collaborators:

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

Case Western Reserve University

Information provided by (Responsible Party):

John Chae, MD, MetroHealth Medical Center

Study Description

Brief Summary:

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 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.

Condition or disease	Intervention/treatment	Phase
Shoulder Pain	Drug: Lidocaine Drug: Triamcinolone + Lidocaine	Phase 2

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 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).

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	28 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Clinical Trials in Stroke Rehabilitation
Study Start Date :	December 2007
Actual Primary Completion Date :	February 2012
Actual Study Completion Date :	February 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Triamcinolone Triamcinolone hexacetonide

Genetic and Rare Diseases Information Center resources: Hemiplegia

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Low Dose Drug: Lidocaine (Neer's Test) Drug: 20 mg Triamcinolone + Lidocaine	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 (Neer's Test) Drug: 40 mg Triamcinolone + Lidocaine	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 (Neer's Test) Drug: 60 mg Triamcinolone + Lidocaine	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

Outcome Measures

Primary Outcome Measures :

BPI 12 (Brief Pain Inventory, Question 12) Pain Questionnaire [ Time Frame: Baseline, weeks 1, 2, 3, 4, 8, 12 (7 times) ]
Change in BPI-12, Worst pain in the last week on 0 (No Pain) to 10 (Worst Pain Possible) scale, from baseline to week 12. The data in the Outcome Measure data table represent the comparison of week 12 to baseline using least squares means from the linear mixed model, but data from all time points are included in the Statistical Analyses to arrive at the reported slopes/group x time interactions.

Secondary Outcome Measures :

Fugl-Meyer Motor Assessment, Upper Limb Domain [ Time Frame: Baseline, weeks 4, 8, 12 (4 times) ]
Evaluates and measures recovery in post-stroke hemiplegic patients. Items are scored on a 3-point ordinal scale:

0 = cannot perform
1. = performs partially
2. = performs fully Scores for 33 motor function items are summed to arrive at a total score ranging from 0 to 66, where higher scores indicate greater motor function Differences baseline to week 12. The data in the Outcome Measure data table represent the comparison of week 12 to baseline using least squares means from the linear mixed model, but data from all time points are included in the Statistical Analyses to arrive at the reported slopes/group x time interactions.
Pain Free External Rotation Range of Motion (ROM) [ Time Frame: Baseline, weeks 4, 8, 12 (4 times) ]
Differences in least-mean squares (Degrees) from baseline to week 12. The data in the Outcome Measure data table represent the comparison of week 12 to baseline using least squares means from the linear mixed model, but data from all time points are included in the Statistical Analyses to arrive at the reported slopes/group x time interactions.
Pain Free Abduction Range of Motion (ROM) [ Time Frame: Baseline, weeks 4, 8, 12 (4 times) ]
Difference in least-squares means (Degrees) from baseline to week 12. The data in the Outcome Measure data table represent the comparison of week 12 to baseline using least squares means from the linear mixed model, but data from all time points are included in the Statistical Analyses to arrive at the reported slopes/group x time interactions.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00597766

Locations


United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109

Sponsors and Collaborators

MetroHealth Medical Center

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

Case Western Reserve University

Investigators


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

More Information


Responsible Party:	John Chae, MD, Prof Vice Chair Physical Medicine and Rehabilitation, MetroHealth Medical Center
ClinicalTrials.gov Identifier:	NCT00597766 History of Changes
Other Study ID Numbers:	K24HD054600 ( U.S. NIH Grant/Contract ) K24HD054600 ( U.S. NIH Grant/Contract )
First Posted:	January 18, 2008 Key Record Dates
Results First Posted:	December 13, 2017
Last Update Posted:	December 13, 2017
Last Verified:	November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No


Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by John Chae, MD, MetroHealth Medical Center:


CVA Hemiplegia Hemiplegic shoulder pain Subacromial steroid injection

Additional relevant MeSH terms:


Shoulder Pain Arthralgia Joint Diseases Musculoskeletal Diseases Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Lidocaine Triamcinolone hexacetonide Triamcinolone Triamcinolone Acetonide Triamcinolone diacetate Anesthetics, Local Anesthetics	Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Immunosuppressive Agents Immunologic Factors

Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Lidocaine
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anesthetics, Local
Anesthetics

Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors

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