Oral CancerNCT07166575
Morphological Changes of Upper Trapezius Muscle After Physotherapy in Oral Cancer
An observational study of Oral Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Oral Cancer
- What is being tested?
- B-mode ultrasonography
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Oct 2025to 31 Dec 2027
- How long will I take part?
- 8 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 10 newly diagnosed oral cancer patients who received neck dissection with scapular dyskinesis
Who may be able to join
- 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.
Who cannot join
- Unable to effectively communicate.
- Diagnosed with conditions affecting motor function.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
School and Graduate Institute of Physical Therapy, Colledge of Medicine, National Taiwan University
Taipei, 100
Yueh-Hsia Chen, PhD, 886-921435981, yuehhsiachen@ntu.edu.tw
About this study
Official title: Ultrasonographic Assessment of Upper Trapezius Mmorphological Changes in Oral Cancer Patients With Scapular Dyskinesis: An Observational Study
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.
Read the 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.
- Conditions
- Oral Cancer
- Being tested
- B-mode ultrasonography
- Keywords
- Ultrasonography, Upper Trapezius, Shoulder, Oral Cancer
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B-mode ultrasonographyDiagnostic test
Thickness and cross-sectional area of upper trapezius muscle
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Pre-intervention, 8 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start16 Oct 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
- Target duration
- 8 Weeks
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yueh-Hsia Chen, PhD, Principal investigator, National Taiwan University, College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166575
- Sponsor's protocol ID
- 202508084RINA
- Status last verified
- Jul 2026
- First submitted
- 2 Sep 2025
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 7211339Warnakulasuriya 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.
PubMed 18804401van 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.
PubMed 12576033Adigozali 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.
PubMed 27331047Valera-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.
PubMed 32947195
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Assessment of Upper Trapezius Mmorphological Changes in Oral Cancer Patients With Scapular Dyskinesis: An Observational Study
- ClinicalTrials.gov ID
- NCT07166575
- Acronym / sponsor ID
- 202508084RINA
- Conditions
- Oral Cancer
- Keywords
- Ultrasonography, Upper Trapezius, Shoulder, Oral Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 16 Oct 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Weeks
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 10 newly diagnosed oral cancer patients who received neck dissection with scapular dyskinesis
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Unable to effectively communicate.
- Diagnosed with conditions affecting motor function.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| B-mode ultrasonographyThickness and cross-sectional area of upper trapezius muscle | Diagnostic test | – |
Primary outcome
Cross-sectional area of upper trapezius muscle
Time frame: Pre-intervention, 8 weeks post-intervention
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.
Thickness of upper trapezius muscle
Time frame: Pre-intervention, 8 weeks post-intervention
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.
Active range of motion in shoulder abduction
Time frame: Pre-intervention, 8 weeks post-intervention
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Results publication: PubMed 7211339Carenfelt 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.
- Results publication: PubMed 18804401Warnakulasuriya 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.
- Results publication: PubMed 12576033van 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.
- Results publication: PubMed 27331047Adigozali 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.
- Results publication: PubMed 32947195Valera-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yueh-Hsia Chen, PhD principal investigator
National Taiwan University, College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yueh-Hsia Chen, PhD (+886-2-33668133, yuehhsiachen@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cross-sectional area of upper trapezius muscle (time frame: Pre-intervention, 8 weeks post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07166575, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.