NCT06472349

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Dec 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress81%
Dec 2023Dec 2026

Study Start

First participant enrolled

December 12, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 25, 2024

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

3 years

First QC Date

June 2, 2024

Last Update Submit

April 9, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Shoulder kinematics

    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.

    During the procedure

  • Muscle activation

    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.

    During the procedure

Secondary Outcomes (11)

  • Oscillation frequency

    During the procedure

  • Dynamic stiffness

    During the procedure

  • Mechanical stress relaxation time (ms)

    During the procedure

  • Muscle thickness and cross-sectional area

    During the procedure

  • Muscle thickness change at rest and in contraction

    During the procedure

  • +6 more secondary outcomes

Study Arms (2)

Chronic shoulder pain group

Healthy control group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Community Sample

You may qualify if:

  • Chronic shoulder pain group
  • 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.

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Yang Ming Chiao Tung University

Taipei, 11221, Taiwan

RECRUITING

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 2, 2024

First Posted

June 25, 2024

Study Start

December 12, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 14, 2026

Record last verified: 2026-04

Locations