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Why Does my Shoulder Hurt? Identifying Factors Associated With the Presence of Pain in Individuals With Full-thickness Rotator Cuff Tears
Sponsor study identifier
observational
260
1 country
1
Study Start
June 5, 2018
Actual (reported)Primary Completion
December 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 5, 2018
Actual (reported)August 9, 2018
Actual (reported)February 27, 2019
Actual (reported)December 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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)
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)
No intervention.
No intervention.
Adults aged 50 to 80 years presenting with symptomatic or asymptomatic full-thickness rotator cuff tears.
Center for Interdisciplinary Research in Rehabilitation and Social Integration (CIRRIS)
Québec, Quebec, Canada
DNA (saliva) samples will be collected at the baseline evaluation only. The samples will be analyzed for pain modulatory genes.
Jean-Sébastien Roy, PT, PhD
Laval University
First Submitted
August 9, 2018
First Posted
February 27, 2019
Study Start
June 5, 2018
Actual (reported)Primary Completion
December 30, 2021
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 20, 2020
Record last verified: 2020-02
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Source: ClinicalTrials.gov.
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