Subacromial Corticosteroid Injection for Hemiplegic Shoulder Pain
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Intervention: Lidocaine; Triamcinolone + Lidocaine; Triamcinolone + Lidocaine; Triamcinolone + Lidocaine
Intervention description: One-time Screening/Eligibility Neer's Test: 5 cc of 2% 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 -- 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 -- 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
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Lidocaine; Triamcinolone diacetate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CVA; Hemiplegia; Hemiplegic shoulder pain; Subacromial steroid injection

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. 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.
    

Eligibility 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