Why Does my Shoulder Hurt? Identifying Factors Associated With the Presence of Pain in Individuals With Full-thickness Rotator Cuff Tears
试验速览
- 阶段
- 不适用
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Change in usual shoulder pain from baseline: Visual analog scale (VAS)
研究概览
简要总结
Full-thickness rotator cuff tears (FTRCT), defined as "through-and-through" tears of one of the shoulder tendons, affect up to 32% of the population (mostly individuals older than 50 years) and are one of the most painful and debilitating shoulder diagnoses. One of the primary challenges for clinical decision-making is the poor association between the presence of FTRCT (detected by medical imaging) and pain, as studies have shown that 2/3 of people with FTRCT are asymptomatic. This challenges the notion that FTRCT causes pain, and highlights the fact that symptoms may be explained by other variables. A better understanding of the factors leading to the development of pain in people with FTRCT would optimize clinical care (including prevention).
The objective of this study is to identify variables associated with pain in people with FTRCT by 1) comparing people with FTRCT with (Symptomatic Group; n=40) and without pain (Asymptomatic Group; n=40); 2) comparing people who initially have pain-free FTRCT (Asymptomatic Group) who develop pain over a 2-year period to those who do not develop pain; and 3) comparing people who initially have painful FTRCT (Symptomatic Group) who become pain-free over a 2-year period to those who remain symptomatic. All participants will undergo an ultrasound examination to confirm the presence of FTRCT, and information on a number of variables (sociodemographic, anatomical, genetic, psychosocial, pain sensitivity, neuromuscular, biomechanical) will be collected. All participants will then be followed for 2 years before being revaluated for pain. Variables will be analysed to determine those associated with pain. As it is crucial to improve our understanding of the mechanisms leading to pain, this project has the potential to impact the musculoskeletal health of Canadians. By considering multiple variables associated with FTRCT, its results could lead to the development of tangible solutions to optimize prevention and recovery.
详细描述
Background: Symptomatic full-thickness rotator cuff tears (FTRCT) affect up to 32% of the population and represent one of the more painful and debilitating shoulder diagnoses. The prevailing model for care pathway decisions is heavily influenced by medical imaging. Yet, the association between FTRCT observed on medical imaging and the presence of pain is poor, as two thirds of FTRCT are asymptomatic. This poses a great challenge to clinical decision-making and questions the belief that FTRCT causes pain. As other factors may explain the presence of pain, a better understanding of this phenomenon needs to be sought.
Objective/hypothesis: The primary objective is to identify variables associated with the presence of pain in individuals with FTRCT. The hypothesis is that given its complex aetiology, no single outcome will be highly associated with pain, rather it will be important to consider several outcomes and their interactions. Secondary objectives include: to explore if a) baseline variables or b) a change in these variables following baseline can predict the development of pain in individuals who initially have asymptomatic FTRCT, and to study if a) baseline variables or b) a change in these variables following baseline can predict the resolution of pain in individuals who initially have symptomatic FTRCT.
Methods: 40 adults with a FTRCT and shoulder pain (Symptomatic Group), and 40 adults with a FTRCT without shoulder pain (Asymptomatic Group) will be included. They will demonstrate a FTRCT on US examinations performed by a radiologist. Included participants will take part in a baseline evaluation during which sociodemographic, anatomical, genetic, psychosocial, pain sensitivity, neuromuscular and biomechanical variables will be assessed. The primary objective (cross-sectional design) will be achieved by determining if differences between groups are based on a sole or on several independent variables, and their relative impact on pain (recursive partitioning, principal component analysis, MANOVA).
The secondary objectives (prospective design) will be achieved by following all participants for 2 years. Every 3 months, the participants will complete a web-based questionnaire asking if they have had shoulder pain. Participants in the Asymptomatic Group who develop pain and participants in the Symptomatic Group who become pain-free will be asked to participate in a follow-up evaluation within a week. Participants who remain pain-free in the Asymptomatic Group and with pain in the Symptomatic Group during the follow-up period will also be asked to participate in a follow-up evaluation at the end of the 2 years (same follow-up evaluation for all participants, similar to baseline evaluations). Logistic regressions will be used to identify the variables associated with pain development and with pain resolution.
Relevance: Before implementing new intervention strategies, a better understanding of factors associated with the presence of pain is needed. By looking at different variables that could explain pain, this project will improve our understanding of FTRCT and fill important knowledge gaps.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •unable to understand French or English;
- •history of upper limb fracture;
- •previous shoulder surgery;
- •cervicobrachialgia or shoulder pain reproduced by neck movement;
- •shoulder capsulitis (restriction of at least 30% in 2 or more directions);
- •rheumatoid, inflammatory or neurological diseases;
- •corticosteroid injection in the previous 6 weeks;
- •cognitive problems interfering with evaluations (Mini-Mental State Examination ≥ 24)
结局指标
主要结局
Change in usual shoulder pain from baseline: Visual analog scale (VAS)
时间窗: From baseline to the follow-up evaluation (end of the 2-year period) (Objective 2 and 3)
Participants will be asked to rate the intensity of their pain on a VAS from 0 to 10, where "0" represents no pain and "10" represents "worst pain imaginable", in the last week, month and 3 months. Highest possible score (worst outcome): 30. Lowest possible score (best outcome): 0. Method to compute total score: sum of each score.
usual shoulder pain from baseline: Visual analog scale (VAS)
时间窗: Baseline score (Objective 1)
Participants will be asked to rate the intensity of their pain on a VAS from 0 to 10,
次要结局
- Change from baseline with regard to: Sociodemographic and occupational factors(From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3))
- Depressive symptoms from baseline: Patient Health Questionnaire(Baseline score (Objective 1))
- Upper extremity work demands from baseline: Revised Upper Extremity Work Demands Scale (currently and previously)(Baseline score (Objective 1))
- Pain sensitivity from baseline: Pressure Pain Threshold (PPT)(Baseline score (Objective 1))
- Change in Range of Motion (ROM) of the affected shoulder from baseline(From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3))
- Range of Motion (ROM) of the affected shoulder from baseline(Baseline ROM (Objective 1))
- Bilateral grip strength with handheld dynamometer from baseline(Baseline score (Objective 1))
- Isometric shoulder strength from baseline, with manual dynamometer(Baseline score (Objective 1))
- Scapular dyskinesis from baseline: Scapula Dyskinesis Test(Baseline score (Objective 1))
- Change in comorbidities from baseline: Self-Administered Comorbidity Questionnaire(From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3))
- Sleep disturbance: PROMIS Sleep Disturbance Questionnaire(Baseline score (Objective 1))
- Sociodemographic and occupational factors(Baseline characteristics (Objective 1))
- Disability and functional limitations of the upper extremity QuickDASH(Baseline score (Objective 1))
- Comorbidities: Self-Administered Comorbidity Questionnaire(Baseline score (Objective 1))
- Perceived stress from baseline: Perceived Stress Scale 4(Baseline score (Objective 1))
- Change in sleep disturbance from baseline: PROMIS Sleep Disturbance Questionnaire(From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3))
- Prevalence and frequency of symptoms from baseline: Nordic Musculoskeletal Questionnaire(Baseline score (Objective 1))
- Anxiety from baseline: State-Trait Anxiety Inventory(Baseline score (Objective 1))
- Change in disability and functional limitations of the upper extremity from baseline: QuickDASH(From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3))
- Change in Structural tissue damage of the shoulder from baseline (ultrasound evaluation performed by a radiologist)(From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3))
- Change in Acromiohumeral distance from baseline(From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3))
- Change in Bilateral grip strength with handheld dynamometer from baseline(From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3))
- Change in Isometric shoulder strength from baseline, with manual dynamometer(BFrom baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3))
- Change in prevalence and frequency of symptoms from baseline: Nordic Musculoskeletal Questionnaire(From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3))
- Change in anxiety from baseline: State-Trait Anxiety Inventory(From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3))
- Change in upper extremity work demands from baseline: Revised Upper Extremity Work Demands Scale (currently and previously)(From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3))
- Change in pain catastrophising from baseline: Pain Catastrophising Scale(From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3))
- Pain catastrophising from baseline: Pain Catastrophising Scale(Baseline score (Objective 1))
- Change in depressive symptoms from baseline: Patient Health Questionnaire(From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3))
- Change in perceived stress from baseline: Perceived Stress Scale 4(From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3))
- Structural tissue damage of the shoulder from baseline (ultrasound evaluation performed by a radiologist)(Baseline observations (Objective 1))
- Acromiohumeral distance from baseline(Baseline distance (Objective 1))
- Change in Radiographical evaluation of the shoulder from baseline(From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3))
- Radiographical evaluation of the shoulder from baseline(Baseline observation (Objective 1))
- Change in pain sensitivity from baseline: Pressure Pain Threshold (PPT)(From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3))
- Shoulder proprioception (arm position matching), coordination and functional dominance with the KINARM exoskeleton (BKIN Technologies)(Baseline score (Objective 1))
- Change in scapular dyskinesis from baseline: Scapula Dyskinesis Test(From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3))
- Change from baseline in Shoulder proprioception (arm position matching), coordination and functional dominance with the KINARM exoskeleton (BKIN Technologies)(From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3))
研究者
Jean-Sébastien Roy
Associate Professor, Faculty of Medicine
Laval University