Clinical Trials in Stroke Rehabilitation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- BPI 12 (Brief Pain Inventory, Question 12) Pain Questionnaire
研究概览
简要总结
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:
- low dose group which receives 20mg of steroid (triamcinolone) injection to the subacromial space of the affected shoulder;
- standard dose group which receives a standard 40mg of steroid (triamcinolone) injection to the subacromial space of the affected shoulder; or
- 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.
详细描述
- 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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
High Dose
Drug: Lidocaine (Neer's Test)
Drug: 60 mg Triamcinolone + Lidocaine
干预措施: Lidocaine (Drug)
Low Dose
Drug: Lidocaine (Neer's Test)
Drug: 20 mg Triamcinolone + Lidocaine
干预措施: Lidocaine (Drug)
Low Dose
Drug: Lidocaine (Neer's Test)
Drug: 20 mg Triamcinolone + Lidocaine
干预措施: Triamcinolone + Lidocaine (Drug)
Standard Dose
Drug: Lidocaine (Neer's Test)
Drug: 40 mg Triamcinolone + Lidocaine
干预措施: Lidocaine (Drug)
Standard Dose
Drug: Lidocaine (Neer's Test)
Drug: 40 mg Triamcinolone + Lidocaine
干预措施: Triamcinolone + Lidocaine (Drug)
High Dose
Drug: Lidocaine (Neer's Test)
Drug: 60 mg Triamcinolone + Lidocaine
干预措施: Triamcinolone + Lidocaine (Drug)
结局指标
主要结局
BPI 12 (Brief Pain Inventory, Question 12) Pain Questionnaire
时间窗: 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.
次要结局
- Pain Free Abduction Range of Motion (ROM)(Baseline, weeks 4, 8, 12 (4 times))
- 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))
研究者
John Chae, MD
Prof Vice Chair Physical Medicine and Rehabilitation
MetroHealth Medical Center