Load-induced Changes in Glenohumeral Translation in Patients With Rotator Cuff Tear

Rotator Cuff Tear Clinical Trial

— LiTrans  

Official title:

LiTrans - Influence of Additional Weight Carrying on Load-induced Changes in Glenohumeral Translation in Patients With Rotator Cuff Tear - a Translational Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04819724
• Other study ID #: 2021-00182; mu21Muendermann
• Status: Completed
• Phase: N/A
• Start date: May 4, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2024
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is to investigate the dose-response relationship between load-induced muscle activation (liMA) and load-induced glenohumeral translation (liTr) in patients with rotator cuff tears and asymptomatic control subjects. Furthermore the study is to investigate the in vivo dose-response relationship between additional weight and glenohumeral translation, to understand the biological variation in liTr, the influence of disease pathology on the liTr, the potential compensation by muscle activation and muscle size, and the influence of liTr on patient outcomes.

Description:

This project is to test the overall hypothesis that rotator cuff tear affects glenohumeral translation and that this functional instability depends on additional load applied, on anatomical and morphological variations, and on type and severity of the injury. The study is to investigate the dose-response relationship between load-induced muscle activation (liMA) and load-induced glenohumeral translation (liTr) in patients with rotator cuff tears and asymptomatic control subjects. Furthermore the study is to investigate the in vivo dose-response relationship between additional weight and glenohumeral translation, to understand the biological variation in liTr, the influence of disease pathology on the liTr, the potential compensation by muscle activation and muscle size, and the influence of liTr on patient outcomes. This study entails cross-sectional experimental multimodal (clinical, biomechanical, radiological) data collection with multiple conditions and a control group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

We will examine a cohort of 75 subjects:

• Group 1: 25 patients with unilateral symptomatic rotator cuff tear between 45 and 85 years
• Group 2: 25 asymptomatic control subjects (age and sex distribution matching the patient group) Group 3: 25 sex matched young asymptomatic control subjects between 20 and 30 years

Inclusion criteria patients:

• Diagnosed unilateral rotator cuff tear
• Partial or complete supraspinatus muscle tear
• With or without injury to other rotator cuff muscles

Exclusion criteria patients:

• Prior operative treatment of the ipsilateral shoulder or elbow
• Clinical history or symptoms of the contralateral glenohumeral joint
• Range of motion <30° in abduction and flexion

Inclusion criteria asymptomatic control subjects:

• No previous known elbow and shoulder injury or symptoms

Exclusion criteria asymptomatic control subjects:

• Clinical history of the glenohumeral joint
• Prior conservative or operative treatment of the shoulder or elbow
• Range of motion <90° in abduction and flexion

General exclusion criteria:

• Inability to provide informed consent
• Body mass index (BMI) > 35 kg/m2 (Excessive skin movement)
• Neuromuscular disorders affecting upper limb movement
• Additional pathologies that influence the mobility of the shoulder joints
• Contraindications for MRI (e.g. neurostimulator and claustrophobia)
• Prior neuromuscular impairment (e.g. stroke)
• Diagnosed active rheumatic disorder
• Other major medical problems
• Pregnancy
• Patients currently enrolled in another experimental (interventional) protocol

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tear

Intervention

Diagnostic Test:
• 3D motion analysis
30° arm abduction in the scapular plane will be performed with and without a handheld weight of 1, 2, 3, and 4 kg. All movements will be done bilaterally. Electromyographic (EMG) data of arm and trunk muscles will be recorded using surface electrodes. Participants will be asked to perform full arm abduction with different rotations (internal, neutral and external rotation), flexion and internal-/external rotations movements (without additional handheld weight).
• isometric shoulder strength by dynamometer
isometric shoulder strength for abduction and internal/external rotation will be assessed with a isometric shoulder strength for abduction and internal/external rotation will be assessed with a dynamometer
• fluoroscopic images of each shoulder
fluoroscopic images (Multitom Rax, Siemens Healthineers, Erlangen, Germany) of each shoulder will be taken during the 30° arm abduction test with and without a handheld weight (0, 2, and 4kg)
• Bilateral shoulder Magnetic Resonance Imaging (MRI)
MRI of both shoulders will be taken

Other:
• data collection by health questionnaires
data collection by health questionnaires

Locations

Country	Name	City	State
Switzerland	Department of Orthopaedics and Traumatology, University Hospital Basel	Basel

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disabilities of arm, shoulder and hand (Quick DASH) questionnaire	30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale (1 being no difficulty, 5 being unable).	at baseline (approximate duration for all questionnaires: 20 minutes)
Primary	Constant Score	The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function.	at baseline (approximate duration for all questionnaires: 20 minutes)
Primary	American Shoulder and Elbow Surgeons (ASES) Shoulder Score	The American Shoulder and Elbow Surgeons Shoulder Score (ASES) is a mixed outcome reporting measure, applicable for use in all patients with shoulder pathology regardless of their specific diagnosis. The ASES questionnaire is composed of both a physician-rated component and a patient-reported component. The patient questions focus on joint pain, instability, and activities of daily living. The pain and functional portions are summed to obtain the final ASES score with higher scores indicating better outcomes.	at baseline (approximate duration for all questionnaires: 20 minutes)
Primary	Subjective Shoulder Value (SSV)	The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%.	at baseline (approximate duration for all questionnaires: 20 minutes)
Primary	numerical pain rating scale (NRS) score	The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults (from 0-10: "0" = no pain. "10" = the most intense pain imaginable)	at baseline (approximate duration for all questionnaires: 20 minutes)
Primary	Loaded shoulder abduction test with motion analysis	The subject will lift their arm to 30° shoulder abduction in the scapular plane, data will be captured holding 0, 1, 2, 3, and 4 kg, respectively, in their hand. Reflective surface markers will be placed bilaterally on the participants' trunk and arms. Position of these markers will be recorded using infrared cameras that only record the reflections of the markers. Additionally, inertial sensors will be positioned on the subjects' thorax, scapulae, humeri and forearms.	at baseline (approximate duration for motion analysis: 50 minutes)
Primary	Loaded shoulder abduction test with single plane fluoroscopic images	fluoroscopic images (Multitom Rax, Siemens Healthineers, Erlangen, Germany) of each shoulder will be taken during the 30° arm abduction test with and without a handheld weight (0, 2, and 4kg)	at baseline (approximate duration for motion analysis: 50 minutes).
Primary	Load-induced muscle activity from electromyography (EMG)	During arm movements in the loaded shoulder test and muscle strength tests, muscle activation of the infraspinatus, biceps brachii, anterior, middle and posterior part of the deltoid, clavicular part of the pectoralis major, latissimus dorsi and the upper part of the trapezius will be measured bilaterally using a 16-channel EMG system	at baseline (approximate duration for motion analysis: 50 minutes)
Primary	Glenohumeral translation from single plane fluoroscopy	the vertical distance of the glenohumeral joint centre (GHJC) and the radiopaque acromion marker will be measured. Fluoroscopy (FL) based liTr will be calculated for each participant as the slope of the regression of the negative GHJC to acromion distance measurements on the load magnitude.	at baseline (approximate duration for motion analysis: 50 minutes)
Primary	Glenohumeral translation from instrumented motion analysis	The vertical distance of the GHJC to the acromion marker will be calculated for a neutral trial and with the arm in 30° shoulder abduction for each loading condition. Motion analysis (MA) based liTr will be calculated for each participant as the slope of the regression of the negative GHJC to acromion distance measurements on the load magnitude	at baseline (approximate duration for motion analysis: 50 minutes)
Primary	Critical shoulder angle (CSA)	Subject's CSA will be measured on an anterior-posterior double-obliquity fluoroscopy image of the shoulder as the angle subtended by a line parallel to the glenoid and a line through the inferior-lateral edge of the glenoid and the inferior-lateral edge of the acromion. The CSA is reproducible and significantly greater in patients with rotator cuff tears than the general population. High angles (>35°-38°) have been associated with rotator cuff tears and greater joint instability.	at baseline (approximate duration for motion analysis: 50 minutes)
Primary	Glenoid inclination (GI)	GI will be measured on the fluoroscopy image as the angle between a line from the upper to the lower glenoid rim (glenoid plane) and a second line set on the floor of the supraspinous fossa. Abnormal GI might be associated with rotator cuff tears and superior humeral head migration.	at baseline (approximate duration for motion analysis: 50 minutes)
Primary	Greater tuberosity angle (GTA)	GTA will be measured as the angle between a line parallel to the humerus diaphysis through the GHJC and a line from the upper border of the humeral head to the most superolateral edge of the greater tuberosity. A GTA of more than 70° has been observed to predict rotator cuff tear.	at baseline (approximate duration for motion analysis: 50 minutes)
Primary	Muscle cross sectional area (MCSA)	The MCSA of all rotator cuff muscles will be measured at two different positions on parasagittal reformatted images. MCSA of the deltoid will also be measured on the axial plane at the middle of the glenoid.	at baseline (approximate duration is approximately 1 hour and 15 minutes)
Primary	Tear size retrieved from MR images	Tear size will be classified into partial (1) or complete supraspinatus muscle tear (2).	at baseline (approximate duration is approximately 1 hour and 15 minutes)
Primary	Tear type retrieved from MR images	Tear type will be classified into supraspinatus tear without injury to other rotator cuff muscles (type A) and with injury to other rotator cuff muscles (type B). Both will be used as indicators for injury severity	at baseline (approximate duration is approximately 1 hour and 15 minutes)
Primary	Isometric shoulder muscle strength for abduction and internal/external rotation	Shoulder muscle strength will be tested under isometric conditions using a dynamometer. The maximum of 3 trials will be calculated and recorded as the participant's maximum isometric strength.	at baseline (approximate duration: 40 minutes).