NCT03857009

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

Status unknown Last updated 20 February 2020

What this trial tests

trial in Full-thickness Rotator Cuff Tear in 260 participants. Status unknown.

Timeline

5 June 2018

Primary endpoint
30 December 2021

30 December 2021

Quick facts

Lead sponsor	Laval University
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	260
Start date	5 June 2018
Primary completion	30 December 2021
Estimated completion	30 December 2021
Sites	1 location across Canada

Conditions studied

• Full-thickness Rotator Cuff Tear — all drugs for Full-thickness Rotator Cuff Tear →

Sponsor

Laval University

Who can join

Adults 50 to 80, any sex, with Full-thickness Rotator Cuff Tear. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.