Shoulder Pain
Conditions
Keywords
CVA, Hemiplegia, Hemiplegic shoulder pain, Subacromial steroid injection
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. 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.
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).
Interventions
DRUGLidocaine
One-time Screening/Eligibility Neer's Test: 5 cc of 2% lidocaine
DRUGTriamcinolone + 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
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Case Western Reserve University
MetroHealth Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BPI 12 (Brief Pain Inventory, Question 12) Pain Questionnaire | 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
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Motor Assessment, Upper Limb Domain | 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) | 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) | 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. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from an urban, academic rehabilitation center from 10/2007 to 6/2012 in the United States.
Pre-assignment details
Subjects had to have a positive Neer's test (50% pain reduction by subacromial lidocaine) to be enrolled and randomized. 59 were screened. 28 subjects were consented and enrolled.
Participants by arm
| Arm | Count |
|---|---|
| 20mg Triamcinolone Low dose group. | 9 |
| 40mg Triamcinolone Standard dose group | 9 |
| 60mg Triamcinolone High dose group | 10 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Follow-up 1, Week 4 | Withdrawal by Subject | 1 | 0 | 0 |
| Follow-up 2, Week 8 | Lost to Follow-up | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | 40mg Triamcinolone | 60mg Triamcinolone | 20mg Triamcinolone | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 9 Participants | 7 Participants | 24 Participants |
| Age, Continuous | 54.7 years STANDARD_DEVIATION 10.2 | 54.0 years STANDARD_DEVIATION 9.9 | 58.3 years STANDARD_DEVIATION 7.1 | 55.6 years STANDARD_DEVIATION 9.1 |
| Region of Enrollment United States | 9 participants | 10 participants | 9 participants | 28 participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 4 Participants | 12 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 5 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 9 | 0 / 9 | 0 / 10 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 | 1 / 10 |
Outcome results
Primary
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.
Time frame: Baseline, weeks 1, 2, 3, 4, 8, 12 (7 times)
Population: We used available-cases. Missing values handled with maximum likelihood methods.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 20mg Triamcinolone | BPI 12 (Brief Pain Inventory, Question 12) Pain Questionnaire | -1.7 units on a scale |
| 40mg Triamcinolone | BPI 12 (Brief Pain Inventory, Question 12) Pain Questionnaire | -2.2 units on a scale |
| 60mg Triamcinolone | BPI 12 (Brief Pain Inventory, Question 12) Pain Questionnaire | -4.7 units on a scale |
Comparison: Hypothesis that 60mg group would have greater pain relief than the the 20mg group.~The study was powered to detect the difference in pain between the 40mg and placebo at 4-wks. To detect effect size 0.75 with alpha of 0.05, beta of 0.20, 31 the difference between the 60mg and placebo groups (effect size \> 1.0),18 participants per group are needed. \*NOTE\* the design was changed from placebo-control due to ethical concerns arising from ethical concerns of placebo injection.p-value: 0.16Linear mixed model
Comparison: Hypothesis that 40mg group would have greater pain reduction than the 20mg group.~The study was powered to detect the difference in pain between the 40mg and placebo at 4-wks. To detect effect size 0.75 with alpha of 0.05, beta of 0.20, 31 the difference between the 60mg and placebo groups (effect size \> 1.0),18 participants per group are needed. \*NOTE\* the design was changed from placebo-control due to ethical concerns arising from ethical concerns of placebo injection.p-value: 0.77linear mixed model
Secondary
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 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.
Time frame: Baseline, weeks 4, 8, 12 (4 times)
Population: Available-case analysis with missing data handled by maximum likelihood methods.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 20mg Triamcinolone | Fugl-Meyer Motor Assessment, Upper Limb Domain | 5.1 units on a scale |
| 40mg Triamcinolone | Fugl-Meyer Motor Assessment, Upper Limb Domain | 4.5 units on a scale |
| 60mg Triamcinolone | Fugl-Meyer Motor Assessment, Upper Limb Domain | 2.3 units on a scale |
Comparison: This study was not powered for secondary outcomes. The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.p-value: 0.2Linear mixed model
Comparison: This study was not powered for secondary outcomes.The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.p-value: 0.9linear mixed model
Secondary
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.
Time frame: Baseline, weeks 4, 8, 12 (4 times)
Population: Available-case analysis with missing data handled by maximum likelihood methods.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 20mg Triamcinolone | Pain Free Abduction Range of Motion (ROM) | 33.3 units on a scale |
| 40mg Triamcinolone | Pain Free Abduction Range of Motion (ROM) | 15.2 units on a scale |
| 60mg Triamcinolone | Pain Free Abduction Range of Motion (ROM) | 28.0 units on a scale |
Comparison: This study was not powered for secondary outcomes.The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.p-value: 0.8linear mixed model
Comparison: This study was not powered for secondary outcomes.The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.p-value: 0.3linear mixed model
Secondary
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.
Time frame: Baseline, weeks 4, 8, 12 (4 times)
Population: Available-case analysis with missing data handled by maximum likelihood methods.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 20mg Triamcinolone | Pain Free External Rotation Range of Motion (ROM) | 26.7 units on a scale |
| 40mg Triamcinolone | Pain Free External Rotation Range of Motion (ROM) | 12.7 units on a scale |
| 60mg Triamcinolone | Pain Free External Rotation Range of Motion (ROM) | 10.3 units on a scale |
Comparison: The study was not powered for secondary analyses. The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.p-value: 0.2linear mixed model
Comparison: Secondary outcomes were not powered for analysis. The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.p-value: 0.3linear mixed model