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Recruiting NCT07166575

Morphological Changes of Upper Trapezius Muscle After Physotherapy in Oral Cancer

Observational Oral Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: B-mode ultrasonography.
Who it may be relevant to
Registry conditions: Oral Cancer. Basic parameters: 20 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Ultrasonographic Assessment of Upper Trapezius Mmorphological Changes in Oral Cancer Patients With Scapular Dyskinesis: An Observational Study

Overview

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.

Detailed description

The study aims to investigate the effect of 8-week physiotherapy on morphological change of upper trapezius muscle in oral cancer patients who have undergone neck dissection. Key outcome measurements include the muscle's thickness and cross-sectional area (CSA), measured via B-mode ultrasonography, as well as the active range of motion (AROM) in shoulder abduction. Neck dissections may result in spinal accessory nerve (CN XI) injury, often leading to shoulder pain, upper trapezius weakness and impaired shoulder mobility. Therefore, understanding the relationship between muscle thickness, CSA, and AROM is important. The study's goal is to explore the correlation between muscle morphological changes and functional outcomes, and further evaluate the role of B-mode ultrasonography as a non-invasive tool in monitoring muscle morphology in shoulder rehabilitation progress with post-surgical oral cancer patients with shoulder dysfunction.

Interventions

  • Diagnostic test B-mode ultrasonography
    Thickness and cross-sectional area of upper trapezius muscle

Primary outcome measures

  • Cross-sectional area of upper trapezius muscle [Time frame: Pre-intervention, 8 weeks post-intervention]
  • Thickness of upper trapezius muscle [Time frame: Pre-intervention, 8 weeks post-intervention]
  • Active range of motion in shoulder abduction [Time frame: Pre-intervention, 8 weeks post-intervention]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Taiwan · 1 center
  • School and Graduate Institute of Physical Therapy, Colledge of Medicine, National Taiwan U — Taipei

Publications

  • 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 7211339
  • 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 18804401
  • 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 12576033
  • 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 27331047
  • 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 32947195

Identifiers

NCT: NCT07166575 · 202508084RINA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗