Why Does my Shoulder Hurt? Understanding the Presence of Pain in Individuals With Full-thickness Rotator Cuff Tears

Full-thickness Rotator Cuff Tear Clinical Trial

Official title:

Why Does my Shoulder Hurt? Identifying Factors Associated With the Presence of Pain in Individuals With Full-thickness Rotator Cuff Tears

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03857009
• Other study ID #: ShoulderPain2018
• Status: Recruiting
• Start date: June 5, 2018
• Est. completion date: December 30, 2021

Study information

• Verified date: February 2020
• Source: Laval University
• Contact: Jean-Sébastien Roy, PT, PhD
• Phone: 4185299141
• Email: jean-sebastien.roy[@]rea.ulaval.ca
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Full-thickness Rotator Cuff Tear
• Rotator Cuff Injuries

Locations

Country	Name	City	State
Canada	Center for Interdisciplinary Research in Rehabilitation and Social Integration (CIRRIS)	Quebec City	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From baseline to the follow-up evaluation (end of the 2-year period) (Objective 2 and 3)
Primary	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,	Baseline score (Objective 1)
Secondary	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	From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Secondary	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	Baseline characteristics (Objective 1)
Secondary	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	From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Secondary	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	Baseline score (Objective 1)
Secondary	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	From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Secondary	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	Baseline score (Objective 1)
Secondary	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	From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Secondary	Sleep disturbance: PROMIS Sleep Disturbance Questionnaire	Qualitative questionnaire on a 5-point Likert scale, where higher scores indicate greater sleep quality	Baseline score (Objective 1)
Secondary	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)	From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Secondary	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)	Baseline score (Objective 1)
Secondary	Change in anxiety from baseline: State-Trait Anxiety Inventory	6 items each scored on a 4-point scale, higher scores denote greater anxiety	From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Secondary	Anxiety from baseline: State-Trait Anxiety Inventory	6 items each scored on a 4-point scale, higher scores denote greater anxiety	Baseline score (Objective 1)
Secondary	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	From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Secondary	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	Baseline score (Objective 1)
Secondary	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.	From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Secondary	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.	Baseline score (Objective 1)
Secondary	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.	From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Secondary	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.	Baseline score (Objective 1)
Secondary	Change in pain catastrophising from baseline: Pain Catastrophising Scale	13-item questionnaire, 5-point scale, greater scores indicate more pain catastrophizing.	From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Secondary	Pain catastrophising from baseline: Pain Catastrophising Scale	13-item questionnaire, 5-point scale, greater scores indicate more pain catastrophizing.	Baseline score (Objective 1)
Secondary	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)	From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Secondary	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)	Baseline observations (Objective 1)
Secondary	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	From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Secondary	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	Baseline distance (Objective 1)
Secondary	Change in Radiographical evaluation of the shoulder from baseline	Presence or absence of calcific tendonitis and/or osteophytes at the glenohumeral and acromioclavicular joints	From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Secondary	Radiographical evaluation of the shoulder from baseline	Presence or absence of calcific tendonitis and/or osteophytes at the glenohumeral and acromioclavicular joints	Baseline observation (Objective 1)
Secondary	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.	From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Secondary	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.	Baseline score (Objective 1)
Secondary	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.	From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Secondary	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.	Baseline ROM (Objective 1)
Secondary	Change in Bilateral grip strength with handheld dynamometer from baseline	Measured in pounds.	From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Secondary	Bilateral grip strength with handheld dynamometer from baseline	Measured in pounds.	Baseline score (Objective 1)
Secondary	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.	BFrom baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Secondary	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.	Baseline score (Objective 1)
Secondary	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.	From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Secondary	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.	Baseline score (Objective 1)
Secondary	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.	From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Secondary	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.	Baseline score (Objective 1)