Clinical Evolution of Hemiparetic Shoulder Pain With a Capsular Pattern in a Subacute Stroke Population Following Physiotherapy Coupled With Cortisone Infiltration and Mild Arthrographic Distension Versus Physiotherapy Alone : A Pragmatic Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pain at night or at rest (whichever scores highest), measured on a visual analog scale from 0 to 10
研究概览
简要总结
The purpose of this study is to assess the efficacy of mild hydraulic distension with intra-articular corticosteroid injection for the treatment of subacute hemiparetic shoulder pain with a capsular pattern of restricted shoulder motion.
详细描述
Research Question:
Is cortisone infiltration with mild arthrographic shoulder distension coupled with physiotherapy superior to physiotherapy alone in subacute post-stroke individuals with hemiparetic shoulder pain and a capsular pattern?
Hypothesis:
The primary hypothesis is that following intra-articular corticosteroid injection with mild distension there is significantly superior decrease in pain during ADLs and pain at rest or at night (whichever is more bothersome at baseline) in the subsequent weeks compared to during physiotherapy alone while awaiting the procedure.
The secondary hypotheses are that there will be significantly superior improvements in passive ROM of the shoulder and level of functioning following intra-articular corticosteroid injection with mild distension coupled with physiotherapy compared to physiotherapy alone. It is expected that those with a larger decrease in pain and a larger increase in ROM will have a superior improvement in their quality of life. The procedure is expected to be safe with only rare and minor complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •All participants must be enrolled in an inpatient rehabilitation program for post-stroke patients at the Institut de réadaptation Gingras-Lindsay-de-Montréal, which is encompassed by the Centre intégré universitaire de santé et de services sociaux du Centre-Sud-de-l'Île-de-Montréal. Participants must be 18 years old or older and apt to give consent and able to reliably express themselves (either verbally, written or other) to participate in the study. Aptitude and ability to express themselves will be clinically assessed by their attending physician. Participants with a score of 3 or less out of 5 on the memory section of the Montreal Cognitive Assessment will receive special attention to ensure that the information obtained is accurate through communication with their treatment team, their medical file or their family and caregivers.
- •The shoulder pain must be significant, as defined by a pain that is bothersome to the patient (limits sleep, limits time spent in wheelchair, limits ADL functioning, discomfort impacting their rehabilitation, or associated with Complex Regional Pain Syndrome), as well as a score of 3/10 on the visual analog scale during rest, at night or during ADLs, despite adequate positioning of the arm. The pain must be present for at least 2 weeks and unresolved by physiotherapy alone. Their current symptoms of shoulder pain must have started after their most recent episode of stroke. There must also be a capsular pattern of reduced ROM of the shoulder, defined by a loss of 10 degrees or more of either external rotation, abduction or internal rotation ROM compared to the non painful shoulder.
排除标准
- •Patients below the age of 18 years will be excluded. Patients with pain duration of more than 6 months will be excluded. Patients inapt to give consent to participate in the study will be excluded.
- •Patients who have had multiple strokes will not be excluded. Non-verbal patients or those with cognitive difficulties will have the option of participating with assistance in answering questionnaires by their primary caregiver, a healthcare worker or information recorded in the medical file. Previous shoulder ailments are not a cause for exclusion from participation but their data may be analysed separately. Patients who refuse intra-articular corticosteroid injection but accept to participate in all other aspects of the study will not be excluded as their long-term evolution undergoing physiotherapy alone may be used as a separate cohort if the sample size is large enough.
研究组 & 干预措施
Physiotherapy alone
Physiotherapy alone after diagnosis of hemiplegic shoulder pain with a capsular pattern. The physiotherapy will focus on stretching and range of motion of the shoulder.
(This is a self-controlled study. The participants' clinical evolution with physiotherapy alone will be compared to their evolution after physiotherapy coupled with the injection.)
干预措施: Physiotherapy alone (Other)
Physiotherapy with mild arthrographic distension
Physiotherapy continues after the participant receives a mild arthrographic distension with corticosteroid of the shoulder.
(This is a self-controlled study. The participants' clinical evolution with physiotherapy alone will be compared to their evolution after physiotherapy coupled with the injection.)
干预措施: Glenohumeral injection of 40mg (1cc) of Triamcinolone and 7cc of 0.5% Bupivacaine coupled with physiotherapy (Drug)
结局指标
主要结局
Pain at night or at rest (whichever scores highest), measured on a visual analog scale from 0 to 10
时间窗: Baseline, 1 week pre-injection, day of injection, 3-4 weeks post-injection, 3 months post-injection
Change of hemiparetic shoulder pain at night or at rest with physiotherapy alone, to be compared with evolution over 3 months post-injection
Pain during activities of daily living (ADLs), measured on a visual analog scale from 0 to 10
时间窗: Baseline, 1 week pre-injection, day of injection, 3-4 weeks post-injection, 3 months post-injection
Change of hemiparetic shoulder pain during ADLs with physiotherapy alone, to be compared with evolution over 3 months post-injection
次要结局
- Level of functioning, measured by the self-care section of the Functional Independence Measure.(Baseline, day of injection, 3-4 weeks post-injection, 3 months post-injection)
- Passive range of motion of shoulder (ROM) including flexion, abduction, internal and external rotation in degrees, measured with a goniometer(Baseline, 1 week pre-injection, day of injection (immediately before and immediately after injection), 3-4 weeks post-injection, 3 months post-injection)
- Side effects, measured via auto-reported side effects and consultation with medical file(Day of injection, 3-4 weeks post-injection, 3 months post-injection)
- Quality of life, measured by the Medical Outcomes Study Short Form 12 applied to their shoulder pain(Baseline, day of injection, 3-4 weeks post-injection, 3 months post-injection)
研究者
Claire Bourgeois
Study Principal Investigator
Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal