Risk Factors for Asymptomatic Rotator Cuff Tears to Become Symptomatic.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

207 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-02

Study Completion Date

2026-10-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Rotator Cuff Tears

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

55 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No