Status:
UNKNOWN
Why Does my Shoulder Hurt? Understanding the Presence of Pain in Individuals With Full-thickness Rotator Cuff Tears
Lead Sponsor:
Laval University
Conditions:
Full-thickness Rotator Cuff Tear
Eligibility:
All Genders
50-80 years
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 on...
Detailed 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...
Eligibility Criteria
Inclusion
- 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:
- 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)
Exclusion
Key Trial Info
Start Date :
June 5 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2021
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT03857009
Start Date
June 5 2018
End Date
December 30 2021
Last Update
February 20 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Center for Interdisciplinary Research in Rehabilitation and Social Integration (CIRRIS)
Québec, Quebec, Canada