- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06472349
Structure and Function of the Upper Trapezius and Its Role in Chronic Shoulder Pain: an Investigation of Kinematics, Morphology, Muscle Quality and Activation Distribution
Prior research has explored factors influencing muscle activation, including muscle thickness, fear avoidance beliefs (kinesiophobia), and somatosensory integration. In individuals with chronic shoulder pain, various characteristics impacting symptoms and treatment outcomes have been identified, such as psychosocial factors, fear avoidance, central sensitization, somatosensory impairments, and brain morphology changes. These shared characteristics affecting both muscle activation and chronic shoulder pain may potentially modulate upper trapezius muscle activation during functional movements in patients with chronic shoulder pain. Notably, there remains a gap in the literature concerning investigations into the upper trapezius muscle's morphology and quality, fear avoidance, central sensitization, somatosensory impairments, and their interplay with upper trapezius muscle activation in chronic shoulder pain patients.
To address these gaps, this study aims to: this study aims to: 1) compare different methods of measuring clavicular kinematics using an electromagnetic tracking system; 2) establish the reliability and validity of measuring muscle thickness and fat infiltration through ultrasound and magnetic resonance imaging; 3) compare shoulder kinematics, muscle activation, muscle morphology, and muscle fat infiltration in individuals with chronic shoulder pain with matched healthy controls; 4) explore the correlation between the factors that may influence upper trapezius muscle activation, including basic data of the subjects, muscle morphology, and muscle fat infiltration.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Taipei, Taiwan, 11221
- Recruiting
- National Yang Ming Chiao Tung University
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Contact:
- Yi-Fen Shih, PhD
- Phone Number: +886-2-2826-7340
- Email: yfshih@ym.edu.tw
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Chronic shoulder pain group
- 18-50 years old18-50 years old
- unilateral and non-traumatic shoulder pain
- pain duration longer than 3 months
- pain intensity more than VAS=2 during movement
- presence 3 of 5 positive pain provocation tests: Hawkins-Kennedy test, Jobe test, or Neer's test Painful Arc, and Resistance Test against External Rotation.
Healthy control group
- presenting no shoulder pain at rest or during daily activities
- negative results of the pain provocation test: Hawkins-Kennedy test, Jobe test, Neer's test, Painful Arc, Resistance Test against External Rotation and Spurling's neck compression test.
Exclusion Criteria:
- Chronic shoulder pain group
- history of significant shoulder trauma, such as fracture or ultrasonography clinically suspected full thickness cuff tear
- recent shoulder dislocation in the last 2 years
- diagnosis of adhesive capsulitis characterized by a gradual and painful loss of both active and passive ROM in all shoulder planes, primarily external rotation
- shoulder pain originating from the cervical spine by using Spurling's neck compression test
- shoulder pain owing to the following disorders: arthritis (e.g., rheumatoid arthritis, osteoarthritis of shoulder complex), neurologic (e.g., stroke), neoplastic (e.g., breast cancer). and/or referred pain (e.g., visceral referred pain)
- corticoid injections over the shoulder during 6 months prior to the study
- history of shoulder and neck surgery
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Healthy control group
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Chronic shoulder pain group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Shoulder kinematics
Time Frame: During the procedure
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The scapular kinematics will be assessed, including scapular internal/external rotation, upward/downward rotation, and posterior/anterior tilt angle.
Clavicular kinematics will be evaluated by measuring clavicular protraction/retraction, elevation/depression, and posterior rotation angle.
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During the procedure
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Muscle activation
Time Frame: During the procedure
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The average root mean square (RMS) value collected from surface EMG and outcomes collected by high-density EMG including average root mean square (RMS) value in whole/upper/lower regions, the RMS value distribution, and position of the barycentre of RMS distribution in different humeral elevation angles and different isometric shoulder and scapular tasks will be the outcome measures related to muscle activation.
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During the procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Oscillation frequency
Time Frame: During the procedure
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The oscillation frequency (Hz) of the muscle obtained from the myotonometer will represent the muscle tone
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During the procedure
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Dynamic stiffness
Time Frame: During the procedure
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The dynamic stiffness (N/m) of the muscle obtained from the myotonometer will represent the muscle tone
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During the procedure
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Mechanical stress relaxation time (ms)
Time Frame: During the procedure
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The mechanical stress relaxation time (ms) of the muscle obtained from the myotonometer will represent the muscle tone
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During the procedure
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Muscle thickness and cross-sectional area
Time Frame: During the procedure
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The upper, middle and lower trapezius muscle thickness and cross-sectional area obtained from MRI and the upper, middle and lower trapezius muscle thickness obtained from musculoskeletal sonography.
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During the procedure
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Muscle thickness change at rest and in contraction
Time Frame: During the procedure
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The muscle thickness at rest, during arm raise at 90o abduction, during 2-kg abduction, during 4-kg abduction, and the change (%) between the latter three and at rest.
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During the procedure
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Muscle fat quantification
Time Frame: During the procedure
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The upper, middle and lower trapezius muscle fat quantification indicate the muscle fat infiltration.
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During the procedure
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Muscle / fat fraction
Time Frame: During the procedure
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The upper, middle and lower trapezius muscle / fat fraction indicate the muscle fat infiltration.
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During the procedure
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Echo intensity
Time Frame: During the procedure
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The echo intensity of the upper, middle and lower trapezius muscle obtained from the musculoskeletal sonography.
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During the procedure
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Pain intensity
Time Frame: During the procedure
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The score obtained from the VAS scale and NRPS scale during the most painful movement represent the pain intensity of the chronic shoulder pain group.
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During the procedure
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Disability level
Time Frame: During the procedure
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The FLEX-SF score and DASH score will indicate the disability level of the subjects.
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During the procedure
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Craniovertebral angle
Time Frame: During the procedure
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The cranial-vertebral angle will indicate the level of forward head posture.
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During the procedure
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NYCU112175AE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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