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

NCT03857009 | Unknown

• 1 other identifier: ShoulderPain2018
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Full-thickness Rotator Cuff Tear

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (38)

• Change from baseline with regard to: Sociodemographic and occupational factors

  From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)

• Sociodemographic and occupational factors

  Baseline characteristics (Objective 1)

• Change in disability and functional limitations of the upper extremity from baseline: QuickDASH

  From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)

• Disability and functional limitations of the upper extremity QuickDASH

  Baseline score (Objective 1)

• Change in comorbidities from baseline: Self-Administered Comorbidity Questionnaire

  From baseline to the follow-up evaluation (end of the 2-year period)(Objective 2 and 3)

Study Arms (2)

Symptomatic

No intervention.

Asymptomatic

No intervention.

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Presence of a full-thickness rotator cuff tear (on ultrasound examination performed by a radiologist)
• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

Center for Interdisciplinary Research in Rehabilitation and Social Integration (CIRRIS)

Québec, Quebec, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

DNA (saliva) samples will be collected at the baseline evaluation only. The samples will be analyzed for pain modulatory genes.

Study Officials

• Jean-Sébastien Roy, PT, PhD

  Laval University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Sébastien Roy, PT, PhD

CONTACT

4185299141; jean-sebastien.roy@rea.ulaval.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Faculty of Medicine

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: February 27, 2019
• Study Start: June 5, 2018
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: February 20, 2020

Record last verified: 2020-02

Locations

CA (1)