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

Primary Purpose

Rotator Cuff Tear

Status

Recruiting

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

3D motion analysis

isometric shoulder strength by dynamometer

fluoroscopic images of each shoulder

Bilateral shoulder Magnetic Resonance Imaging (MRI)

data collection by health questionnaires

About this trial

This is an interventional diagnostic trial for Rotator Cuff Tear focused on measuring glenohumeral translation, Load-induced Glenohumeral Translation (liTr ), Load-induced Muscle Activation (liMA)

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Department of Orthopaedics and Traumatology, University Hospital BaselRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Arm Label

Group 1: patient group (unilateral rotator cuff tear)

Group 2: control group (asymptomatic volunteers)

Group 2: young control group (young asymptomatic volunteers)

Arm Description

Group 1: 25 patients with unilateral symptomatic rotator cuff tear

Group 2: (asymptomatic volunteers) 25 asymptomatic control subjects (age and sex distribution matching the patient group)

Group 3: (young asymptomatic volunteers) 25 asymptomatic control subjects, 20 to 30 years (sex distribution matching the patient group)

Outcomes

Primary Outcome Measures

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).

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.

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.

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%.

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)

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.

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)

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

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.

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

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.

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.

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.

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.

Tear size retrieved from MR images

Tear size will be classified into partial (1) or complete supraspinatus muscle tear (2).

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

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04819724

First Posted

March 24, 2021

Last Updated

May 16, 2022

Sponsor

University Hospital, Basel, Switzerland

Collaborators

Swiss National Science Foundation

1. Study Identification

Unique Protocol Identification Number

NCT04819724

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 4, 2021 (Actual)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Basel, Switzerland

Collaborators

Swiss National Science Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rotator Cuff Tear

Keywords

glenohumeral translation, Load-induced Glenohumeral Translation (liTr ), Load-induced Muscle Activation (liMA)

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

cross-sectional experimental multimodal (clinical, biomechanical, radiological) data collection with multiple conditions and a control group

Masking

None (Open Label)

Masking Description

Blinding to the experimental condition is not possible because of the obvious differences between conditions (additional load). However, the person processing the data will be blinded to the condition.

Allocation

Non-Randomized

Enrollment

75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1: patient group (unilateral rotator cuff tear)

Arm Type

Other

Arm Description

Group 1: 25 patients with unilateral symptomatic rotator cuff tear

Arm Title

Group 2: control group (asymptomatic volunteers)

Arm Type

Other

Arm Description

Group 2: (asymptomatic volunteers) 25 asymptomatic control subjects (age and sex distribution matching the patient group)

Arm Title

Group 2: young control group (young asymptomatic volunteers)

Arm Type

Other

Arm Description

Group 3: (young asymptomatic volunteers) 25 asymptomatic control subjects, 20 to 30 years (sex distribution matching the patient group)

Intervention Type

Diagnostic Test

Intervention Name(s)

3D motion analysis

Intervention Description

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).

Intervention Type

Diagnostic Test

Intervention Name(s)

isometric shoulder strength by dynamometer

Intervention Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

fluoroscopic images of each shoulder

Intervention Description

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)

Intervention Type

Diagnostic Test

Intervention Name(s)

Bilateral shoulder Magnetic Resonance Imaging (MRI)

Intervention Description

MRI of both shoulders will be taken

Intervention Type

Other

Intervention Name(s)

data collection by health questionnaires

Intervention Description

data collection by health questionnaires

Primary Outcome Measure Information:

Title

Disabilities of arm, shoulder and hand (Quick DASH) questionnaire

Description

Time Frame

at baseline (approximate duration for all questionnaires: 20 minutes)

Title

Constant Score

Description

Time Frame

at baseline (approximate duration for all questionnaires: 20 minutes)

Title

American Shoulder and Elbow Surgeons (ASES) Shoulder Score

Description

Time Frame

at baseline (approximate duration for all questionnaires: 20 minutes)

Title

Subjective Shoulder Value (SSV)

Description

The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%.

Time Frame

at baseline (approximate duration for all questionnaires: 20 minutes)

Title

numerical pain rating scale (NRS) score

Description

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)

Time Frame

at baseline (approximate duration for all questionnaires: 20 minutes)

Title

Loaded shoulder abduction test with motion analysis

Description

Time Frame

at baseline (approximate durationfor motion analysis: 50 minutes)

Title

Loaded shoulder abduction test with single plane fluoroscopic images

Description

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)

Time Frame

at baseline (approximate duration for motion analysis: 50 minutes).

Title

Load-induced muscle activity from electromyography (EMG)

Description

Time Frame