NCT07166575

Brief Summary

The study aims to evaluate the morphological changes of upper trapezius muscle, using B-mode ultrasonography, in patients with oral cancer undergone neck dissection and physiotherapy. It also investigates the relationship between morphological changes and shoulder active range of motion in abduction. Furthermore , the study assesses the potential of B-mode ultrasonography as an objective tool for monitoring outcomes of the rehabilitation in this population.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
3mo left

Started Sep 2025

Shorter than P25 for all trials

Status
not yet 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 Progress74%
Sep 2025Jul 2026

First Submitted

Initial submission to the registry

September 2, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 10, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

September 15, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

September 10, 2025

Status Verified

August 1, 2025

Enrollment Period

11 months

First QC Date

September 2, 2025

Last Update Submit

September 2, 2025

Conditions

Keywords

UltrasonographyUpper TrapeziusShoulderOral Cancer

Outcome Measures

Primary Outcomes (3)

  • Cross-sectional area of upper trapezius muscle

    CSA of the upper trapezius muscle is measured via B-mode panoramic ultrasonography. Panoramic B-mode ultrasonography will be performed by placing the probe at the spinous process of the fourth cervical vertebra (C4) and moving it laterally toward the posterior margin of the sternocleidomastoid muscle.

    Pre-intervention, 8 weeks post-intervention

  • Thickness of upper trapezius muscle

    Thickness of upper trapezius muscle is measured via B-mode ultrasonography. The ultrasound probe will be positioned at the midpoint between the spinous process of the seventh cervical vertebra (C7) and the acromion, aligned parallel to the muscle fibers.

    Pre-intervention, 8 weeks post-intervention

  • Active range of motion in shoulder abduction

    AROM in shoulder abduction is measured by a goniometer, with the fulcrum positioned over the anterior aspect of the acromial process. The proximal arm is aligned parallel to the midline of the anterior aspect of the sternum, while the distal arm is aligned with the anterior midline of the humerus.

    Pre-intervention, 8 weeks post-intervention

Interventions

B-mode ultrasonographyDIAGNOSTIC_TEST

Thickness and cross-sectional area of upper trapezius muscle

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A total of 10 newly diagnosed oral cancer patients who received neck dissection with scapular dyskinesis

You may qualify if:

  • Newly diagnosed oral cancer patients with scapular dyskinesis, who have undergone neck dissections within 3 months
  • Able to cooperate with assessments and physical therapy, and capable of understanding and signing the informed consent form.
  • Age between 20 and 65 years.

You may not qualify if:

  • Unable to effectively communicate.
  • Diagnosed with conditions affecting motor function.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Carenfelt C, Eliasson K. Occurrence, duration and prognosis of unexpected accessory nerve paresis in radical neck dissection. Acta Otolaryngol. 1980 Nov-Dec;90(5-6):470-3. doi: 10.3109/00016488009131750.

    PMID: 7211339BACKGROUND
  • Warnakulasuriya S. Global epidemiology of oral and oropharyngeal cancer. Oral Oncol. 2009 Apr-May;45(4-5):309-16. doi: 10.1016/j.oraloncology.2008.06.002. Epub 2008 Sep 18.

    PMID: 18804401BACKGROUND
  • van Wilgen CP, Dijkstra PU, van der Laan BF, Plukker JT, Roodenburg JL. Shoulder complaints after neck dissection; is the spinal accessory nerve involved? Br J Oral Maxillofac Surg. 2003 Feb;41(1):7-11. doi: 10.1016/s0266-4356(02)00288-7.

    PMID: 12576033BACKGROUND
  • Adigozali H, Shadmehr A, Ebrahimi E, Rezasoltani A, Naderi F. Ultrasonography for the assessment of the upper trapezius properties in healthy females: a reliability study. Muscles Ligaments Tendons J. 2016 May 19;6(1):167-72. doi: 10.11138/mltj/2016.6.1.167. eCollection 2016 Jan-Mar.

    PMID: 27331047BACKGROUND
  • Valera-Calero JA, Gallego-Sendarrubias G, Fernandez-de-Las-Penas C, Cleland JA, Ortega-Santiago R, Arias-Buria JL. Cross-sectional area of the cervical extensors assessed with panoramic ultrasound imaging: Preliminary data in healthy people. Musculoskelet Sci Pract. 2020 Dec;50:102257. doi: 10.1016/j.msksp.2020.102257. Epub 2020 Sep 11.

    PMID: 32947195BACKGROUND

MeSH Terms

Conditions

Mouth Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic Diseases

Study Officials

  • Yueh-Hsia Chen, PhD

    National Taiwan University, College of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yueh-Hsia Chen, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
8 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2025

First Posted

September 10, 2025

Study Start

September 15, 2025

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

September 10, 2025

Record last verified: 2025-08