Clinical trial NCT05896475: Risk Factors for Asymptomatic Rotator Cuff Tears to Become Symptomatic.
Official title: Why do Asymptomatic Rotator Cuff Tears Become Painful? Effect of Biomechanical, Psychosocial and Painrelated Factors.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rotator Cuff Tears
Keywords: Asymptomatic rotator cuff tears
Symptom registration
Observational study
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2023-06-09
Enrollment: 207
Sex: ALL
Minimum age (years): 55
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 55+ years old subjects with an asymptomatic rotator cuff tear

Brief summary: In this prospective study, subjects older than 55 years with a degenerative asymptomatic rotator cuff tears will be followed for a period of 2 years. After testing, a symptom registration form will be filled in every 3 months. The test moment consists of pain measurements (pain pressure thresholds and conditioned pain modulation), biomechanical measurements (strength (including hand grip strength), range of motion, ultrasound (while measuring electromyographic activity) and shear wave elastography) and psychosocial measurements (psychosocial questionnaires).

Detailed description: In this prospective study, the aim is to determine the risk factors for developing a symptomatic rotator cuff (RC) tear. It is still unknown why some patients with a RC tear develop complaints and others do not. Better understanding of the etiological factors that underlie RC pathology will increase the efficacy of early clinical intervention. A prospective study with a minimum of 2 year follow-up will be conducted. Biomechanical, psychosocial and painrelated factors will be screened as possible risk factors. We hypothesize that negative psychosocial factors and biomechanical impairments will be risk factors for an asymptomatic tear to become symptomatic over time.

Eligibility criteria: Inclusion Criteria:

* 55+ years old
* male or female
* asymptomatic rotator cuff tear diagnosed with ultrasound by a medical doctor
* mean visual analogue score (VAS) of \< 3 during daily life activities
* no shoulder complaints having a significant influence on daily life activities

Exclusion Criteria:

* recent shoulder trauma
* massive rotator cuff tears
* small partial thickness tears
* neck complaints
* history of shoulder surgery
* history of proximal upper arm fracture
* frozen shoulder
* inflammatory arthritis
* peripheral or central disorders
* cognitive disorders

Primary outcomes:
measure: Pressure Pain Thresholds (PPT)
timeFrame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
measure: Acromiohumeral distance (AHD)
timeFrame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
Secondary outcomes:
measure: Clinical tests - mobility
timeFrame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
measure: Clinical test - strength
timeFrame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
measure: Conditioned Pain Modulation (CPM)
timeFrame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
measure: Central Sensitization Inventory (CSI)
timeFrame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
measure: Tampa Scale for Kinesiophobia (TSK)
timeFrame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
measure: Short Form-36 (SF-36)
timeFrame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
measure: Depression, anxiety and stress scale (DASS-21)
timeFrame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
measure: General Self-Efficacy Scale (GSES)
timeFrame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
measure: Electromyographic activity (EMG)
timeFrame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
measure: Shear Wave Elastography (SWE)
timeFrame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
measure: Supraspinatus muscle thickness
timeFrame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
measure: Humeral glenoid distance (HGD)
timeFrame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Department of rehabilitation sciences
state: Oost-Vlaanderen
Study officials:
affiliation: Orthopaedics and Traumatology Ghent University Hospital
name: Alexander Van Tongel, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References: