Risk Factors for Asymptomatic Rotator Cuff Tears to Become Symptomatic.

July 6, 2023 updated by: University Ghent

Why do Asymptomatic Rotator Cuff Tears Become Painful? Effect of Biomechanical, Psychosocial and Painrelated Factors.

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).

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

207

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Recruiting
        • Department of rehabilitation sciences
        • Contact:
        • Principal Investigator:
          • Alexander Van Tongel, MD, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

55+ years old subjects with an asymptomatic rotator cuff tear

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure Pain Thresholds (PPT)
Time Frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
PPTs will be measured on three local locations around the shoulder (supraspinatus, infraspinatus and posterior deltoid). Additionally, two more distal PPTs will be measured (erector spinae and triceps surae).
Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
Acromiohumeral distance (AHD)
Time Frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
The AHD is the shortest linear distance between the inferior edge of the acromion and the superior edge of the humeral head. This will be measured during rest and during muscle activity.
Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical tests - mobility
Time Frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
Passive and active scaption - passive external rotation in supine position with arm in 90° abduction - passive internal rotation in supine position with arm in 90° abduction.
Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
Clinical test - strength
Time Frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
45° scapular elevation - external rotation - internal rotation - hand grip strength
Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
Conditioned Pain Modulation (CPM)
Time Frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
The conditioning stimulus will comprise of immersion of the foot until the proximal ankle (level of the malleoli) in a hot circulating water bath of 45.5°C during 1 minute. The test stimulus will comprise of pressure pain threshold (PPT) assessments (as described above) before and after completion of the conditioning stimulus.
Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
Central Sensitization Inventory (CSI)
Time Frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
The CSI measures the participant's Central Sensitization Syndrome related symptoms. The higher the score, the more signs of central sensitization are present.
Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
Tampa Scale for Kinesiophobia (TSK)
Time Frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
The TSK evaluates the general pain related fear of movement. The higher the score, the higher the pain related fear.
Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
Short Form-36 (SF-36)
Time Frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
The SF-36 evaluates the general health and well-being or quality of life. Contains a physical and mental component score. A higher score expresses a better health condition.
Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
Shoulder Pain and Disability Index (SPADI)
Time Frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
The SPADI evaluates the pain and restrictions in activities. The higher the score, the worse the symptoms.
Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
Depression, anxiety and stress scale (DASS-21)
Time Frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
DASS-21 evaluates the depression (7 items); anxiety (7 items) and stress (7 items). The score will be multiplied by 2 to have a comparable score with the DASS-42.
Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
International Physical Activity Questionnaire (IPAQ)
Time Frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
The IPAQ will be used to evaluate the physical activity level of the participants. This questionnaire contains 31 questions in 5 domains: 1) physical activity during work; 2) physical activity concerning transport; 3) physical activity by doing household chores; 4) physical activity concerning sport activities; 5) sitting time.
Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
Insomnia Severity Index (ISI)
Time Frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
Seven questions to ask for sleep problems.
Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
General Self-Efficacy Scale (GSES)
Time Frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
The GSES measures (10 statements) how a person deals with stressors/difficult situations in life. The scale is about a person's self-confidence that his or her actions are responsible for successful outcomes or, in other words, that one has control over challenging demands imposed by the environment.
Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
Shear Wave Elastography (SWE)
Time Frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
This is a non-invasive and real time assessment of tissue mechanical properties that measures the elasticity of the muscles/tendons. The higher the shear modulus/young modulus/shear wave speed, the higher the stiffness. SWE assessment will be done for the followings muscles: supraspinatus, infraspinatus, anterior and posterior deltoid.
Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
Supraspinatus muscle thickness
Time Frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
The supraspinatus muscle thickness will be measured on two locations: 1) midpoint of the line cranial to the spina scapula; 2) 2 cm medial to the midpoint of the line cranial to the spina scapulae. One longitudinal and one transverse measurement at each of the scanning sites will be performed. This will be measured in mm.
Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
Humeral glenoid distance (HGD)
Time Frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
The HGD is the distance between the most posterior point of the humeral head and the posterior glenoid. This will be measured in mm.
Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
Electromyographic activity (EMG)
Time Frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
Electromyographic activity will be measured during AHD measurement in rest and during activity. The amplitude of the EMG activity from the three parts of the deltoid (anterior, middle and posterior part) will be obtained. The unit is volt. EMG activity will be expressed as percentage of the MVIC (maximal voluntary isometric contraction).
Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ghent

Investigators

  • Principal Investigator: Alexander Van Tongel, Prof. dr., Orthopaedics and Traumatology Ghent University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2023

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

May 31, 2023

First Submitted That Met QC Criteria

May 31, 2023

First Posted (Actual)

June 9, 2023

Study Record Updates

Last Update Posted (Actual)

July 7, 2023

Last Update Submitted That Met QC Criteria

July 6, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B6702023000172
  • BOF22/DOC/005 (Other Grant/Funding Number: Bijzonder Onderzoeksfonds (BOF))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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