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

2020. február 19. frissítette: Jean-Sébastien Roy, Laval University

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.

A tanulmány áttekintése

Állapot

Ismeretlen

Körülmények

Részletes leírás

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.

Tanulmány típusa

Megfigyelő

Beiratkozás (Várható)

260

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányi helyek

  • Kanada
    • Quebec
      • Quebec City, Quebec, Kanada
        • Toborzás
        • Center for Interdisciplinary Research in Rehabilitation and Social Integration (CIRRIS)

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

50 év (Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Összes

Mintavételi módszer

Nem valószínűségi minta

Tanulmányi populáció

Adults aged 50 to 80 years presenting with symptomatic or asymptomatic full-thickness rotator cuff tears.

Leírás

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)

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Megfigyelési modellek: Kohorsz
  • Időperspektívák: Leendő

Kohorszok és beavatkozások

Csoport / Kohorsz
Symptomatic
No intervention.
Asymptomatic
No intervention.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Change in usual shoulder pain from baseline: Visual analog scale (VAS)
Időkeret: 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.
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)
Időkeret: Baseline score (Objective 1)
Participants will be asked to rate the intensity of their pain on a VAS from 0 to 10,
Baseline score (Objective 1)

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Change from baseline with regard to: Sociodemographic and occupational factors
Időkeret: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
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)
Sociodemographic and occupational factors
Időkeret: Baseline characteristics (Objective 1)
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)
Change in disability and functional limitations of the upper extremity from baseline: QuickDASH
Időkeret: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
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)
Disability and functional limitations of the upper extremity QuickDASH
Időkeret: Baseline score (Objective 1)
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)
Change in comorbidities from baseline: Self-Administered Comorbidity Questionnaire
Időkeret: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
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)
Comorbidities: Self-Administered Comorbidity Questionnaire
Időkeret: Baseline score (Objective 1)
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)
Change in sleep disturbance from baseline: PROMIS Sleep Disturbance Questionnaire
Időkeret: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
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)
Sleep disturbance: PROMIS Sleep Disturbance Questionnaire
Időkeret: Baseline score (Objective 1)
Qualitative questionnaire on a 5-point Likert scale, where higher scores indicate greater sleep quality
Baseline score (Objective 1)
Change in prevalence and frequency of symptoms from baseline: Nordic Musculoskeletal Questionnaire
Időkeret: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
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)
Prevalence and frequency of symptoms from baseline: Nordic Musculoskeletal Questionnaire
Időkeret: Baseline score (Objective 1)
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)
Change in anxiety from baseline: State-Trait Anxiety Inventory
Időkeret: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
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)
Anxiety from baseline: State-Trait Anxiety Inventory
Időkeret: Baseline score (Objective 1)
6 items each scored on a 4-point scale, higher scores denote greater anxiety
Baseline score (Objective 1)
Change in depressive symptoms from baseline: Patient Health Questionnaire
Időkeret: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
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)
Depressive symptoms from baseline: Patient Health Questionnaire
Időkeret: Baseline score (Objective 1)
9-item questionnaire evaluating depressive symptoms, on a 4-point scale where higher scores denote higher frequency of depressive symptoms
Baseline score (Objective 1)
Change in perceived stress from baseline: Perceived Stress Scale 4
Időkeret: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
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)
Perceived stress from baseline: Perceived Stress Scale 4
Időkeret: Baseline score (Objective 1)
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)
Change in upper extremity work demands from baseline: Revised Upper Extremity Work Demands Scale (currently and previously)
Időkeret: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
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)
Upper extremity work demands from baseline: Revised Upper Extremity Work Demands Scale (currently and previously)
Időkeret: Baseline score (Objective 1)
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)
Change in pain catastrophising from baseline: Pain Catastrophising Scale
Időkeret: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
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)
Pain catastrophising from baseline: Pain Catastrophising Scale
Időkeret: Baseline score (Objective 1)
13-item questionnaire, 5-point scale, greater scores indicate more pain catastrophizing.
Baseline score (Objective 1)
Change in Structural tissue damage of the shoulder from baseline (ultrasound evaluation performed by a radiologist)
Időkeret: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
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)
Structural tissue damage of the shoulder from baseline (ultrasound evaluation performed by a radiologist)
Időkeret: Baseline observations (Objective 1)
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)
Change in Acromiohumeral distance from baseline
Időkeret: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
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)
Acromiohumeral distance from baseline
Időkeret: Baseline distance (Objective 1)
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)
Change in Radiographical evaluation of the shoulder from baseline
Időkeret: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
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)
Radiographical evaluation of the shoulder from baseline
Időkeret: Baseline observation (Objective 1)
Presence or absence of calcific tendonitis and/or osteophytes at the glenohumeral and acromioclavicular joints
Baseline observation (Objective 1)
Change in pain sensitivity from baseline: Pressure Pain Threshold (PPT)
Időkeret: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
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)
Pain sensitivity from baseline: Pressure Pain Threshold (PPT)
Időkeret: Baseline score (Objective 1)
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)
Change in Range of Motion (ROM) of the affected shoulder from baseline
Időkeret: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
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)
Range of Motion (ROM) of the affected shoulder from baseline
Időkeret: Baseline ROM (Objective 1)
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)
Change in Bilateral grip strength with handheld dynamometer from baseline
Időkeret: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
Measured in pounds.
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
Időkeret: Baseline score (Objective 1)
Measured in pounds.
Baseline score (Objective 1)
Change in Isometric shoulder strength from baseline, with manual dynamometer
Időkeret: BFrom baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
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)
Isometric shoulder strength from baseline, with manual dynamometer
Időkeret: Baseline score (Objective 1)
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)
Change in scapular dyskinesis from baseline: Scapula Dyskinesis Test
Időkeret: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
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)
Scapular dyskinesis from baseline: Scapula Dyskinesis Test
Időkeret: Baseline score (Objective 1)
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)
Change from baseline in Shoulder proprioception (arm position matching), coordination and functional dominance with the KINARM exoskeleton (BKIN Technologies)
Időkeret: From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)
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)
Shoulder proprioception (arm position matching), coordination and functional dominance with the KINARM exoskeleton (BKIN Technologies)
Időkeret: Baseline score (Objective 1)
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)

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Laval University

Nyomozók

  • Kutatásvezető: Jean-Sébastien Roy, PT, PhD, Laval University

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2018. június 5.

Elsődleges befejezés (Várható)

2021. december 30.

A tanulmány befejezése (Várható)

2021. december 30.

Tanulmányi regisztráció dátumai

Először benyújtva

2018. augusztus 9.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2019. február 25.

Első közzététel (Tényleges)

2019. február 27.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2020. február 20.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2020. február 19.

Utolsó ellenőrzés

2020. február 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • ShoulderPain2018

Gyógyszer- és eszközinformációk, tanulmányi dokumentumok

Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz

Nem

Egy amerikai FDA által szabályozott eszközterméket tanulmányoz

Nem

Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .

Klinikai vizsgálatok a Teljes vastagságú Rotator Cuff Tear

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