Clinical trial NCT03857009: Why Does my Shoulder Hurt? Understanding the Presence of Pain in Individuals With Full-thickness Rotator Cuff Tears
Official title: Why Does my Shoulder Hurt? Identifying Factors Associated With the Presence of Pain in Individuals With Full-thickness Rotator Cuff Tears
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Full-thickness Rotator Cuff Tear
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2019-02-27
Enrollment: 260
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults aged 50 to 80 years presenting with symptomatic or asymptomatic full-thickness rotator cuff tears.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria (all participants):

* Presence of a full-thickness rotator cuff tear (on ultrasound examination performed by a radiologist)
* 50 to 80 years of age
* Degenerative tear (no significant trauma)

Inclusion Criteria for the Symptomatic group:

* unilateral or bilateral shoulder pain (at least 2/10 on a visual analog scale \[VAS\] evaluating usual shoulder pain)
* positive response to: 'In the past 4 weeks, have you had pain in your shoulder' and 'If yes, was this pain bad enough to limit your usual activities or change your daily routine for more than 1 day?'

Inclusion Criteria for the Asymptomatic group:

* report no current shoulder pain (0/10 on a VAS evaluating usual shoulder pain)
* negative response to: 'In the past 4 weeks, have you had pain in your shoulder'
* do not report any past significant shoulder pain (any pain greater than or equal to 2/10 that lasted longer than 4 weeks, required the use of medications or prompted a physician visit)

Exclusion Criteria:

1. unable to understand French or English;
2. history of upper limb fracture;
3. previous shoulder surgery;
4. cervicobrachialgia or shoulder pain reproduced by neck movement;
5. shoulder capsulitis (restriction of at least 30% in 2 or more directions);
6. rheumatoid, inflammatory or neurological diseases;
7. corticosteroid injection in the previous 6 weeks;
8. cognitive problems interfering with evaluations (Mini-Mental State Examination ≥ 24)

Primary outcomes:
measure: Change in usual shoulder pain from baseline: Visual analog scale (VAS)
timeFrame: From baseline to the follow-up evaluation (end of the 2-year period) (Objective 2 and 3)
measure: usual shoulder pain from baseline: Visual analog scale (VAS)
timeFrame: Baseline score (Objective 1)
Secondary outcomes:
measure: Change from baseline with regard to: Sociodemographic and occupational factors
timeFrame: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
measure: Sociodemographic and occupational factors
timeFrame: Baseline characteristics (Objective 1)
measure: Change in disability and functional limitations of the upper extremity from baseline: QuickDASH
timeFrame: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
measure: Disability and functional limitations of the upper extremity QuickDASH
timeFrame: Baseline score (Objective 1)
measure: Change in comorbidities from baseline: Self-Administered Comorbidity Questionnaire
timeFrame: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
measure: Comorbidities: Self-Administered Comorbidity Questionnaire
timeFrame: Baseline score (Objective 1)
measure: Change in sleep disturbance from baseline: PROMIS Sleep Disturbance Questionnaire
timeFrame: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
measure: Sleep disturbance: PROMIS Sleep Disturbance Questionnaire
timeFrame: Baseline score (Objective 1)
measure: Change in prevalence and frequency of symptoms from baseline: Nordic Musculoskeletal Questionnaire
timeFrame: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
measure: Prevalence and frequency of symptoms from baseline: Nordic Musculoskeletal Questionnaire
timeFrame: Baseline score (Objective 1)
measure: Change in anxiety from baseline: State-Trait Anxiety Inventory
timeFrame: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
measure: Anxiety from baseline: State-Trait Anxiety Inventory
timeFrame: Baseline score (Objective 1)
measure: Change in depressive symptoms from baseline: Patient Health Questionnaire
timeFrame: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
measure: Depressive symptoms from baseline: Patient Health Questionnaire
timeFrame: Baseline score (Objective 1)
measure: Change in perceived stress from baseline: Perceived Stress Scale 4
timeFrame: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
measure: Perceived stress from baseline: Perceived Stress Scale 4
timeFrame: Baseline score (Objective 1)
measure: Change in upper extremity work demands from baseline: Revised Upper Extremity Work Demands Scale (currently and previously)
timeFrame: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
measure: Upper extremity work demands from baseline: Revised Upper Extremity Work Demands Scale (currently and previously)
timeFrame: Baseline score (Objective 1)
measure: Change in pain catastrophising from baseline: Pain Catastrophising Scale
timeFrame: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
measure: Pain catastrophising from baseline: Pain Catastrophising Scale
timeFrame: Baseline score (Objective 1)
measure: Change in Structural tissue damage of the shoulder from baseline (ultrasound evaluation performed by a radiologist)
timeFrame: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
measure: Structural tissue damage of the shoulder from baseline (ultrasound evaluation performed by a radiologist)
timeFrame: Baseline observations (Objective 1)
measure: Change in Acromiohumeral distance from baseline
timeFrame: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
measure: Acromiohumeral distance from baseline
timeFrame: Baseline distance (Objective 1)
measure: Change in Radiographical evaluation of the shoulder from baseline
timeFrame: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
measure: Radiographical evaluation of the shoulder from baseline
timeFrame: Baseline observation (Objective 1)
measure: Change in pain sensitivity from baseline: Pressure Pain Threshold (PPT)
timeFrame: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
measure: Pain sensitivity from baseline: Pressure Pain Threshold (PPT)
timeFrame: Baseline score (Objective 1)
measure: Change in Range of Motion (ROM) of the affected shoulder from baseline
timeFrame: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
measure: Range of Motion (ROM) of the affected shoulder from baseline
timeFrame: Baseline ROM (Objective 1)
measure: Change in Bilateral grip strength with handheld dynamometer from baseline
timeFrame: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
measure: Bilateral grip strength with handheld dynamometer from baseline
timeFrame: Baseline score (Objective 1)
measure: Change in Isometric shoulder strength from baseline, with manual dynamometer
timeFrame: BFrom baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
measure: Isometric shoulder strength from baseline, with manual dynamometer
timeFrame: Baseline score (Objective 1)
measure: Change in scapular dyskinesis from baseline: Scapula Dyskinesis Test
timeFrame: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
measure: Scapular dyskinesis from baseline: Scapula Dyskinesis Test
timeFrame: Baseline score (Objective 1)
measure: Change from baseline in Shoulder proprioception (arm position matching), coordination and functional dominance with the KINARM exoskeleton (BKIN Technologies)
timeFrame: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
measure: Shoulder proprioception (arm position matching), coordination and functional dominance with the KINARM exoskeleton (BKIN Technologies)
timeFrame: Baseline score (Objective 1)
Other outcomes:
Locations:
city: Quebec City
country: Canada
facility: Center for Interdisciplinary Research in Rehabilitation and Social Integration (CIRRIS)
state: Quebec
Study officials:
affiliation: Laval University
name: Jean-Sébastien Roy, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: