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Risk Factors for Asymptomatic Rotator Cuff Tears to Become Symptomatic.

U

University Ghent

Status

Enrolling

Conditions

Rotator Cuff Tears

Study type

Observational

Funder types

Other

Identifiers

NCT05896475
BOF22/DOC/005 (Other Grant/Funding Number)
ONZ-2023-0062

Details and patient eligibility

About

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).

Full 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.

Enrollment

207 estimated patients

Sex

All

Ages

55 to 100 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Ann Cools, Prof. dr.; Dorien Borms, dr.

Data sourced from clinicaltrials.gov

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