Department of rehabilitation sciences
Ghent, Oost-Vlaanderen, 9000, Belgium
Location status: Recruiting
Location contact
Alexander Van Tongel, MD, PhD
PRINCIPAL_INVESTIGATOR
Ann Cools, PT, PhD
CONTACT
Dorien Borms, PT
CONTACT
NCT Number: NCT05896475
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).
Interested in participating?
Request Info55 year–100 year
All sexes
Observational
Ghent, Oost-Vlaanderen, 9000, Belgium
Location status: Recruiting
Alexander Van Tongel, MD, PhD
PRINCIPAL_INVESTIGATOR
Ann Cools, PT, PhD
CONTACT
Dorien Borms, PT
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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.
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.
Time frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
45° scapular elevation - external rotation - internal rotation - hand grip strength
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.
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.
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.
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.
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.
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.
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.
Time frame: Baseline - 2 year if remaining asymptomatic or at moment of becoming symptomatic
Seven questions to ask for sleep problems.
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.
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).
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Ann Cools, Prof. dr.
CONTACT
Dorien Borms, dr.
CONTACT
University Ghent
Other
Why do Asymptomatic Rotator Cuff Tears Become Painful? Effect of Biomechanical, Psychosocial and Painrelated Factors.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06289686
Rotator Cuff Injuries, Rotator Cuff Tears
Air Force Academy, Colorado, United States
View Trial DetailsNCT06918041
Rotator Cuff Injuries, Rotator Cuff Tear
Chicago, Illinois, United States
View Trial DetailsNCT06733480
Anatomic Total Shoulder Arthroplasty, Reverse Total Shoulder Arthroplasty
Cleveland, Ohio, United States
View Trial DetailsNCT07383038
Physical Disability, Rotator Cuff Injuries
Kırşehir, Turkey (Türkiye)
View Trial Details