Full-thickness Rotator Cuff TearNCT03857009
Why Does my Shoulder Hurt? Understanding the Presence of Pain in Individuals With Full-thickness Rotator Cuff Tears
An observational study of Full-thickness Rotator Cuff Tear, run by Laval University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Full-thickness Rotator Cuff Tear
- How many people
- 260 participants
- Where
- 1 siteCanada
- Study dates
- 5 Jun 2018to 30 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults aged 50 to 80 years presenting with symptomatic or asymptomatic full-thickness rotator cuff tears.
Who may be able to join
- 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)
- 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?'
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Center for Interdisciplinary Research in Rehabilitation and Social Integration (CIRRIS)
Québec, Quebec
Jean-Sébastien Roy, PT, PhD, 1-418-529-9141 ext. 6005, jean-sebastien.roy@rea.ulaval.ca
About this study
Official title: Why Does my Shoulder Hurt? Identifying Factors Associated With the Presence of Pain in Individuals With Full-thickness Rotator Cuff Tears
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.
Read the 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.
- Conditions
- Full-thickness Rotator Cuff Tear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic | No intervention. | |
| Asymptomatic | No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in usual shoulder pain from baseline: Visual analog scale (VAS)
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.
Measured: From baseline to the follow-up evaluation (end of the 2-year period) (Objective 2 and 3)
usual shoulder pain from baseline: Visual analog scale (VAS)
Participants will be asked to rate the intensity of their pain on a VAS from 0 to 10,
Measured: Baseline score (Objective 1)
Secondary outcomes (38)
Change from baseline with regard to: Sociodemographic and occupational factors
General sociodemographic questionnaire including sex; gender; date of birth; age; height; weight; hand dominance; racial, ethnic or cultural origin; civil status; education level; occupation; employment status; overhead sports activities (currently or previously); household income; smoking habits
Measured: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Sociodemographic and occupational factors
General sociodemographic questionnaire including sex; gender; date of birth; age; height; weight; hand dominance; racial, ethnic or cultural origin; civil status; education level; occupation; employment status; overhead sports activities (currently or previously); household income; smoking habits
Measured: Baseline characteristics (Objective 1)
Change in disability and functional limitations of the upper extremity from baseline: QuickDASH
Questionnaire comprising 11 questions evaluating disability and functional limitations of the upper extremity on a scale from 1 to 5, where 1 denotes full capacity and 5 denotes incapacity
Measured: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Disability and functional limitations of the upper extremity QuickDASH
Questionnaire comprising 11 questions evaluating disability and functional limitations of the upper extremity on a scale from 1 to 5, where 1 denotes full capacity and 5 denotes incapacity
Measured: Baseline score (Objective 1)
Change in comorbidities from baseline: Self-Administered Comorbidity Questionnaire
Questionnaire determining the presence or absence of 13 health problems, whether or not the person is treated for each problem, and whether or not the problem interferes with / limits their activities
Measured: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Comorbidities: Self-Administered Comorbidity Questionnaire
Questionnaire determining the presence or absence of 13 health problems, whether or not the person is treated for each problem, and whether or not the problem interferes with / limits their activities
Measured: Baseline score (Objective 1)
Change in sleep disturbance from baseline: PROMIS Sleep Disturbance Questionnaire
Qualitative questionnaire on a 5-point Likert scale, where higher scores indicate greater sleep quality
Measured: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Sleep disturbance: PROMIS Sleep Disturbance Questionnaire
Qualitative questionnaire on a 5-point Likert scale, where higher scores indicate greater sleep quality
Measured: Baseline score (Objective 1)
Change in prevalence and frequency of symptoms from baseline: Nordic Musculoskeletal Questionnaire
Questionnaire evaluating the prevalence of pain (dichotomous scale, "yes" or "no") in all regions of the body (in the last week, last 3 months and last 12 months), and the frequency of pain/symptoms in each region of the body (scale from 0 to 3, where higher scores indicate higher frequency of symptoms)
Measured: 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
Questionnaire evaluating the prevalence of pain (dichotomous scale, "yes" or "no") in all regions of the body (in the last week, last 3 months and last 12 months), and the frequency of pain/symptoms in each region of the body (scale from 0 to 3, where higher scores indicate higher frequency of symptoms)
Measured: Baseline score (Objective 1)
Change in anxiety from baseline: State-Trait Anxiety Inventory
6 items each scored on a 4-point scale, higher scores denote greater anxiety
Measured: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Anxiety from baseline: State-Trait Anxiety Inventory
6 items each scored on a 4-point scale, higher scores denote greater anxiety
Measured: Baseline score (Objective 1)
Change in depressive symptoms from baseline: Patient Health Questionnaire
9-item questionnaire evaluating depressive symptoms, on a 4-point scale where higher scores denote higher frequency of depressive symptoms
Measured: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Depressive symptoms from baseline: Patient Health Questionnaire
9-item questionnaire evaluating depressive symptoms, on a 4-point scale where higher scores denote higher frequency of depressive symptoms
Measured: Baseline score (Objective 1)
Change in perceived stress from baseline: Perceived Stress Scale 4
4-item questionnaire, scored on a 5-point scale from 0 ("never") to 4 ("very often"). Higher scores are correlated to more stress.
Measured: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Perceived stress from baseline: Perceived Stress Scale 4
4-item questionnaire, scored on a 5-point scale from 0 ("never") to 4 ("very often"). Higher scores are correlated to more stress.
Measured: Baseline score (Objective 1)
Change in upper extremity work demands from baseline: Revised Upper Extremity Work Demands Scale (currently and previously)
6-item scale scored from 1 ("rarely / never") to 4 ("almost always"), higher scores indicate greater physical work demands on the upper extremity.
Measured: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Upper extremity work demands from baseline: Revised Upper Extremity Work Demands Scale (currently and previously)
6-item scale scored from 1 ("rarely / never") to 4 ("almost always"), higher scores indicate greater physical work demands on the upper extremity.
Measured: Baseline score (Objective 1)
Change in pain catastrophising from baseline: Pain Catastrophising Scale
13-item questionnaire, 5-point scale, greater scores indicate more pain catastrophizing.
Measured: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Pain catastrophising from baseline: Pain Catastrophising Scale
13-item questionnaire, 5-point scale, greater scores indicate more pain catastrophizing.
Measured: Baseline score (Objective 1)
Change in Structural tissue damage of the shoulder from baseline (ultrasound evaluation performed by a radiologist)
Full thickness rotator cuff tears will be classified by size defined as small (<10 mm), medium (10 to 30 mm) or large (>30 mm)
Measured: 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)
Full thickness rotator cuff tears will be classified by size defined as small (<10 mm), medium (10 to 30 mm) or large (>30 mm)
Measured: Baseline observations (Objective 1)
Change in Acromiohumeral distance from baseline
Ultrasound (US scanner) will be used to measure the acromiohumeral distance of the affected shoulder at 0 degrees and 60 degrees of shoulder abduction
Measured: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Acromiohumeral distance from baseline
Ultrasound (US scanner) will be used to measure the acromiohumeral distance of the affected shoulder at 0 degrees and 60 degrees of shoulder abduction
Measured: Baseline distance (Objective 1)
Change in Radiographical evaluation of the shoulder from baseline
Presence or absence of calcific tendonitis and/or osteophytes at the glenohumeral and acromioclavicular joints
Measured: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Radiographical evaluation of the shoulder from baseline
Presence or absence of calcific tendonitis and/or osteophytes at the glenohumeral and acromioclavicular joints
Measured: Baseline observation (Objective 1)
Change in pain sensitivity from baseline: Pressure Pain Threshold (PPT)
PPT will be assessed bilaterally at the middle deltoid and tibialis anterior muscles using a mechanical pressure algometer at an applied rate of 1 kg/s. The amount of pressure at which pain is perceived (in Newtons) will be recorded (mean of 3 trials). Higher scores denote less pain sensitivity.
Measured: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Pain sensitivity from baseline: Pressure Pain Threshold (PPT)
PPT will be assessed bilaterally at the middle deltoid and tibialis anterior muscles using a mechanical pressure algometer at an applied rate of 1 kg/s. The amount of pressure at which pain is perceived (in Newtons) will be recorded (mean of 3 trials). Higher scores denote less pain sensitivity.
Measured: Baseline score (Objective 1)
Change in Range of Motion (ROM) of the affected shoulder from baseline
Shoulder ROM in flexion, lateral rotation at 0° abduction, and lateral and medial rotation at 90° abduction will be measured using a goniometer (flexion) and an inclinometer (other measures). Values will be compared to normative data according to age.
Measured: 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
Shoulder ROM in flexion, lateral rotation at 0° abduction, and lateral and medial rotation at 90° abduction will be measured using a goniometer (flexion) and an inclinometer (other measures). Values will be compared to normative data according to age.
Measured: Baseline ROM (Objective 1)
Change in Bilateral grip strength with handheld dynamometer from baseline
Measured in pounds.
Measured: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Bilateral grip strength with handheld dynamometer from baseline
Measured in pounds.
Measured: Baseline score (Objective 1)
Change in Isometric shoulder strength from baseline, with manual dynamometer
Isometric shoulder strength in abduction and in lateral rotation at 0° abduction will be measured in Newtons with a manual dynamometer (MedUp), and normalized by lever arm, measured in meters using a measuring tape.
Measured: BFrom baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Isometric shoulder strength from baseline, with manual dynamometer
Isometric shoulder strength in abduction and in lateral rotation at 0° abduction will be measured in Newtons with a manual dynamometer (MedUp), and normalized by lever arm, measured in meters using a measuring tape.
Measured: Baseline score (Objective 1)
Change in scapular dyskinesis from baseline: Scapula Dyskinesis Test
Bilateral scapular dyskinesis measured on a 3-point scale: normal (0 points), subtle (1 point), obvious (2 points). Higher scores indicate greater dyskinesis.
Measured: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Scapular dyskinesis from baseline: Scapula Dyskinesis Test
Bilateral scapular dyskinesis measured on a 3-point scale: normal (0 points), subtle (1 point), obvious (2 points). Higher scores indicate greater dyskinesis.
Measured: Baseline score (Objective 1)
Change from baseline in Shoulder proprioception (arm position matching), coordination and functional dominance with the KINARM exoskeleton (BKIN Technologies)
Three KINARM standard tasks will be used to evaluate bilateral upper extremity neuromuscular control. Units of measurement: error in cm and task score (arm position matching task), and task score for the coordination and functional dominance tasks. Task scores are calculated by KINARM software according to variables such as precision and speed.
Measured: 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)
Three KINARM standard tasks will be used to evaluate bilateral upper extremity neuromuscular control. Units of measurement: error in cm and task score (arm position matching task), and task score for the coordination and functional dominance tasks. Task scores are calculated by KINARM software according to variables such as precision and speed.
Measured: Baseline score (Objective 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start5 Jun 2018
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Full-thickness Rotator Cuff TearStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Sébastien Roy, Laval University
- Investigators
- Jean-Sébastien Roy, PT, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857009
- Sponsor's protocol ID
- ShoulderPain2018
- Status last verified
- Feb 2020
- First submitted
- 9 Aug 2018
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Why Does my Shoulder Hurt? Identifying Factors Associated With the Presence of Pain in Individuals With Full-thickness Rotator Cuff Tears
- ClinicalTrials.gov ID
- NCT03857009
- Acronym / sponsor ID
- ShoulderPain2018
- Conditions
- Full-thickness Rotator Cuff Tear
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 27 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symptomatic | – | –No intervention. |
| Asymptomatic | – | –No intervention. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 50 to 80 years presenting with symptomatic or asymptomatic full-thickness rotator cuff tears.
Key inclusion criteria (8 listed)
- 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)
- 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?'
Key exclusion criteria (8 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in usual shoulder pain from baseline: Visual analog scale (VAS)
Time frame: 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)
Time frame: Baseline score (Objective 1)
Participants will be asked to rate the intensity of their pain on a VAS from 0 to 10,
38 secondary outcomes
Change from baseline with regard to: Sociodemographic and occupational factors
Time frame: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Sociodemographic and occupational factors
Time frame: Baseline characteristics (Objective 1)
Change in disability and functional limitations of the upper extremity from baseline: QuickDASH
Time frame: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Disability and functional limitations of the upper extremity QuickDASH
Time frame: Baseline score (Objective 1)
Change in comorbidities from baseline: Self-Administered Comorbidity Questionnaire
Time frame: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Comorbidities: Self-Administered Comorbidity Questionnaire
Time frame: Baseline score (Objective 1)
Change in sleep disturbance from baseline: PROMIS Sleep Disturbance Questionnaire
Time frame: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Sleep disturbance: PROMIS Sleep Disturbance Questionnaire
Time frame: Baseline score (Objective 1)
Change in prevalence and frequency of symptoms from baseline: Nordic Musculoskeletal Questionnaire
Time frame: 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
Time frame: Baseline score (Objective 1)
Change in anxiety from baseline: State-Trait Anxiety Inventory
Time frame: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Anxiety from baseline: State-Trait Anxiety Inventory
Time frame: Baseline score (Objective 1)
Change in depressive symptoms from baseline: Patient Health Questionnaire
Time frame: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Depressive symptoms from baseline: Patient Health Questionnaire
Time frame: Baseline score (Objective 1)
Change in perceived stress from baseline: Perceived Stress Scale 4
Time frame: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Perceived stress from baseline: Perceived Stress Scale 4
Time frame: Baseline score (Objective 1)
Change in upper extremity work demands from baseline: Revised Upper Extremity Work Demands Scale (currently and previously)
Time frame: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Upper extremity work demands from baseline: Revised Upper Extremity Work Demands Scale (currently and previously)
Time frame: Baseline score (Objective 1)
Change in pain catastrophising from baseline: Pain Catastrophising Scale
Time frame: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Pain catastrophising from baseline: Pain Catastrophising Scale
Time frame: Baseline score (Objective 1)
Change in Structural tissue damage of the shoulder from baseline (ultrasound evaluation performed by a radiologist)
Time frame: 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)
Time frame: Baseline observations (Objective 1)
Change in Acromiohumeral distance from baseline
Time frame: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Acromiohumeral distance from baseline
Time frame: Baseline distance (Objective 1)
Change in Radiographical evaluation of the shoulder from baseline
Time frame: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Radiographical evaluation of the shoulder from baseline
Time frame: Baseline observation (Objective 1)
Change in pain sensitivity from baseline: Pressure Pain Threshold (PPT)
Time frame: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Pain sensitivity from baseline: Pressure Pain Threshold (PPT)
Time frame: Baseline score (Objective 1)
Change in Range of Motion (ROM) of the affected shoulder from baseline
Time frame: 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
Time frame: Baseline ROM (Objective 1)
Change in Bilateral grip strength with handheld dynamometer from baseline
Time frame: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Bilateral grip strength with handheld dynamometer from baseline
Time frame: Baseline score (Objective 1)
Change in Isometric shoulder strength from baseline, with manual dynamometer
Time frame: BFrom baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Isometric shoulder strength from baseline, with manual dynamometer
Time frame: Baseline score (Objective 1)
Change in scapular dyskinesis from baseline: Scapula Dyskinesis Test
Time frame: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Scapular dyskinesis from baseline: Scapula Dyskinesis Test
Time frame: Baseline score (Objective 1)
Change from baseline in Shoulder proprioception (arm position matching), coordination and functional dominance with the KINARM exoskeleton (BKIN Technologies)
Time frame: 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)
Time frame: Baseline score (Objective 1)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
Related trials for Full-thickness Rotator Cuff Tear
Recruiting
Cold and Compression After Rotator Cuff Repair (RCR)
High-grade Partial or Full Thickness Rotator Cuff Tears
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Sébastien Roy, PT, PhD principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Full-thickness Rotator Cuff Tear, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Sébastien Roy, PT, PhD (4185299141 ext. 6005, jean-sebastien.roy@rea.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in usual shoulder pain from baseline: Visual analog scale (VAS) (time frame: From baseline to the follow-up evaluation (end of the 2-year period) (Objective 2 and 3)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.