Subacromial Corticosteroid Injection for Hemiplegic Shoulder Pain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was  Recruiting
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
  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:

  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 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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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

ClinicalTrials.gov processed this record on August 21, 2014