Subacromial Corticosteroid Injection for Hemiplegic Shoulder Pain

NCT00597766 | Completed Phase 2 Results

• 1 other identifier: K24HD054600
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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:

1. 1.low dose group which receives 20mg of steroid (triamcinolone) injection to the subacromial space of the affected shoulder;
2. 2.standard dose group which receives a standard 40mg of steroid (triamcinolone) injection to the subacromial space of the affected shoulder; or
3. 3.high dose group which receives 60mg of steroid (triamcinolone) injection to the subacromial space of the affected shoulder.

Conditions

Shoulder Pain

Keywords

CVA; Hemiplegia; Hemiplegic shoulder pain; Subacromial steroid injection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Fugl-Meyer Motor Assessment, Upper Limb Domain

  Baseline, weeks 4, 8, 12 (4 times)

• Pain Free External Rotation Range of Motion (ROM)

  Baseline, weeks 4, 8, 12 (4 times)

• Pain Free Abduction Range of Motion (ROM)

  Baseline, weeks 4, 8, 12 (4 times)

Study Arms (3)

Low Dose

ACTIVE COMPARATOR

Drug: Lidocaine (Neer's Test) Drug: 20 mg Triamcinolone + Lidocaine

Drug: Lidocaine; Drug: Triamcinolone + Lidocaine

Standard Dose

ACTIVE COMPARATOR

Drug: Lidocaine (Neer's Test) Drug: 40 mg Triamcinolone + Lidocaine

Drug: Lidocaine; Drug: Triamcinolone + Lidocaine

High Dose

EXPERIMENTAL

Drug: Lidocaine (Neer's Test) Drug: 60 mg Triamcinolone + Lidocaine

Drug: Lidocaine; Drug: Triamcinolone + Lidocaine

Interventions

Lidocaine DRUG

One-time Screening/Eligibility Neer's Test: 5 cc of 2% lidocaine

High Dose; Low Dose; Standard Dose

Triamcinolone + Lidocaine DRUG

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

Also known as: Kenalog = Triamcinolone

Low Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MetroHealth Medical Center: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Case Western Reserve University: collaborator

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Related Links

• The MetroHealth System - Clinical Trials

MeSH Terms

Conditions

Shoulder Pain; Hemiplegia

Interventions

Lidocaine; Triamcinolone; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Paralysis; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Limitations and Caveats

The study was powered to detect differnces between high-dose and placebo, and standard-dose and placebo. The trial was altered due to ethical concerns for placebo injection due to apparent effectiveness in the literature. Low dose was substituted.

Results Point of Contact

• Title: Dr. Richard Wilson
• Organization: MetroHealth Medical Center

rwilson@metrohealth.org

216-957-3529

Study Officials

• John Chae, MD

  MetroHealth Medical Center; Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Vice Chair Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: January 9, 2008
• First Posted: January 18, 2008
• Study Start: December 1, 2007
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: December 13, 2017
• Results First Posted: December 13, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)