Load-induced Changes in Glenohumeral Translation in Patients With Rotator Cuff Tear
NCT ID: NCT04819724
Last Updated: 2024-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
75 participants
INTERVENTIONAL
2021-05-04
2023-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Group 1: patient group (unilateral rotator cuff tear)
Group 1: 25 patients with unilateral symptomatic rotator cuff tear
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
data collection by health questionnaires
data collection by health questionnaires
Group 2: control group (asymptomatic volunteers)
Group 2: (asymptomatic volunteers) 25 asymptomatic control subjects (age and sex distribution matching the patient group)
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
data collection by health questionnaires
data collection by health questionnaires
Group 2: young control group (young asymptomatic volunteers)
Group 3: (young asymptomatic volunteers) 25 asymptomatic control subjects, 20 to 30 years (sex distribution matching the patient group)
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
data collection by health questionnaires
data collection by health questionnaires
Interventions
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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
data collection by health questionnaires
data collection by health questionnaires
Eligibility Criteria
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Inclusion Criteria
* Partial or complete supraspinatus muscle tear
* With or without injury to other rotator cuff muscles
\- No previous known elbow and shoulder injury or symptoms
Exclusion Criteria
* Clinical history or symptoms of the contralateral glenohumeral joint
* Range of motion \<30° in abduction and flexion
* Clinical history of the glenohumeral joint
* Prior conservative or operative treatment of the shoulder or elbow
* Range of motion \<90° in abduction and flexion
* 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
20 Years
85 Years
ALL
Yes
Sponsors
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Swiss National Science Foundation
OTHER
University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Annegret Mündermann, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Department of Orthopaedics and Traumatology, University Hospital Basel
Locations
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Department of Orthopaedics and Traumatology, University Hospital Basel
Basel, , Switzerland
Countries
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References
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Croci E, Hess H, Genter J, Baum C, Kovacs BK, Nuesch C, Baumgartner D, Gerber K, Muller AM, Mundermann A. Severity of rotator cuff disorders and additional load affect fluoroscopy-based shoulder kinematics during arm abduction. J Orthop Traumatol. 2024 Jun 8;25(1):30. doi: 10.1186/s10195-024-00774-2.
Croci E, Warmuth F, Baum C, Kovacs BK, Nuesch C, Baumgartner D, Muller AM, Mundermann A. Load-induced increase in muscle activity during 30 degrees abduction in patients with rotator cuff tears and control subjects. J Orthop Traumatol. 2023 Aug 4;24(1):41. doi: 10.1186/s10195-023-00720-8.
Croci E, Eckers F, Nuesch C, Aghlmandi S, Kovacs BK, Genter J, Baumgartner D, Muller AM, Mundermann A. Load-Induced Glenohumeral Translation After Rotator Cuff Tears: Protocol for an In Vivo Study. JMIR Res Protoc. 2022 Dec 23;11(12):e43769. doi: 10.2196/43769.
Other Identifiers
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2021-00182; mu21Muendermann
Identifier Type: -
Identifier Source: org_study_id
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