Subacromial Corticosteroid Injection for Hemiplegic Shoulder Pain

Clinical Trials in Stroke Rehabilitation

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:

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.

Study Overview

• Status: Completed
• Conditions: Shoulder Pain
• Intervention / Treatment: Drug: Lidocaine; Drug: Triamcinolone + Lidocaine; Drug: Triamcinolone + Lidocaine; Drug: Triamcinolone + 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 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 Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: Kenalog = Triamcinolone; 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 Names: Kenalog = Triamcinolone; 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 Names: 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; 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 Names: Kenalog = Triamcinolone; 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 Names: Kenalog = Triamcinolone; 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 Names: 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; 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 Names: Kenalog = Triamcinolone; 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 Names: Kenalog = Triamcinolone; 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 Names: Kenalog = Triamcinolone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BPI 12 (Brief Pain Inventory, Question 12) Pain Questionnaire	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.	Baseline, weeks 1, 2, 3, 4, 8, 12 (7 times)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer Motor Assessment, Upper Limb Domain	Evaluates and measures recovery in post-stroke hemiplegic patients. Items are scored on a 3-point ordinal scale: 0 = cannot perform; = performs partially; = 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.	Baseline, weeks 4, 8, 12 (4 times)
Pain Free External Rotation Range of Motion (ROM)	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.	Baseline, weeks 4, 8, 12 (4 times)
Pain Free Abduction Range of Motion (ROM)	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.	Baseline, weeks 4, 8, 12 (4 times)

Collaborators and Investigators

• Sponsor: MetroHealth Medical Center
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (ACTUAL): February 1, 2012
• Study Completion (ACTUAL): February 1, 2012

Study Registration Dates

• First Submitted: January 9, 2008
• First Submitted That Met QC Criteria: January 17, 2008
• First Posted (ESTIMATE): January 18, 2008

Study Record Updates

• Last Update Posted (ACTUAL): December 13, 2017
• Last Update Submitted That Met QC Criteria: November 11, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Hemiplegic shoulder pain; CVA; Hemiplegia; Subacromial steroid injection
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: K24HD054600 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No