Risk Factors for Asymptomatic Rotator Cuff Tears to Become Symptomatic.

Rotator Cuff Tears Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05896475
• Other study ID #: B6702023000172
• Secondary ID: BOF22/DOC/005
• Status: Recruiting
• Start date: June 2, 2023
• Est. completion date: October 2026

Study information

• Verified date: July 2023
• Source: University Ghent
• Contact: Dorien Borms, dr.
• Phone: +32 9 332 26 34
• Email: dorien.borms[@]ugent.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 207
• Est. completion date: October 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears

Locations

Country	Name	City	State
Belgium	Department of rehabilitation sciences	Ghent	Oost-Vlaanderen

Sponsors (1)

Lead Sponsor	Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pressure Pain Thresholds (PPT)	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
Primary	Acromiohumeral distance (AHD)	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	Clinical tests - mobility	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
Secondary	Clinical test - strength	45° scapular elevation - external rotation - internal rotation - hand grip strength	Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
Secondary	Conditioned Pain Modulation (CPM)	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
Secondary	Central Sensitization Inventory (CSI)	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
Secondary	Tampa Scale for Kinesiophobia (TSK)	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
Secondary	Short Form-36 (SF-36)	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
Secondary	Shoulder Pain and Disability Index (SPADI)	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
Secondary	Depression, anxiety and stress scale (DASS-21)	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
Secondary	International Physical Activity Questionnaire (IPAQ)	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
Secondary	Insomnia Severity Index (ISI)	Seven questions to ask for sleep problems.	Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
Secondary	General Self-Efficacy Scale (GSES)	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
Secondary	Electromyographic activity (EMG)	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
Secondary	Shear Wave Elastography (SWE)	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
Secondary	Supraspinatus muscle thickness	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
Secondary	Humeral glenoid distance (HGD)	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