RehabilitationNCT06852261
Early vs. Late Referral for Scapular Exercises in Shoulder Function After Neck Dissection
A study testing Scapular-focused exercise in people with Rehabilitation, run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial summary
This study aims to investigate the effects of comparing early versus late referrals for scapular-focused exercise on shoulder function in head and neck cancer patients following neck dissection. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Rehabilitation
- What is being tested?
- Scapular-focused exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesTaiwan
- Study dates
- 25 Feb 2025to 31 Dec 2027
- Phase
- Interventional
- 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
Who may be able to join
- Age between 20 and 65 years.
- Newly diagnosed with head and neck cancer and experiencing clinical symptoms of accessory nerve dysfunction after unilateral neck dissection, such as shoulder drooping, restricted active range of motion in shoulder abduction, or insufficient muscle strength against gravity in shoulder abduction.
- Scapular dyskinesia, such as asymmetrical scapular movement in multiple planes.
- Scapular asymmetry, defined as a bilateral difference of more than 1.5 cm between the inferior angle of the scapula and the spinous process of the seventh thoracic vertebra when performing 90° shoulder abduction in the scapular plane under a 1 kg load.
Who cannot join
- Presence of distant metastasis or cancer recurrence.
- Inability to communicate or comprehend the questionnaire.
- History of shoulder pain within one year before neck dissection.
- Any condition that may affect motor performance.
- History of neuromuscular disorders or tendon pathology in the affected shoulder, other than accessory nerve dysfunction.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
National Taiwan Univerisity Hospital
Taipei
National Taiwan University Hospital
Taipei
About this study
Official title: Comparison of Early Versus Late Referral for Scapular-Focused Exercise on Shoulder Function in Head and Neck Cancer Patients Following Neck Dissection
This study aims to investigate the effects of comparing early versus late referrals for scapular-focused exercise on shoulder function in head and neck cancer patients following neck dissection.
Read the detailed description
This study will recruit 30 head and neck cancer patients with spinal accessory nerve shoulder dysfunction based on the timing of referral, which will be divided into early (within 2 months post-surgery) and late (after 2 months post-surgery) referral groups. Both groups will receive conventional physical therapy (e.g., shoulder joint mobility training, electrical stimulation, or laser therapy for pain relief) and scapular-focused exercises. Scapular-focused exercise primarily targets the trapezius muscle, 60 minutes each session, once a week for 12 weeks.
- Conditions
- Rehabilitation
- Being tested
- Scapular-focused exercise
- Keywords
- shoulder, exercise, Head and Neck Cancer
- Medical subject headings
- Motor Activity, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scapular-focused exerciseBehavioural
Scapular-focused exercise primarily targets the trapezius muscle, 60 minutes each session, once a week for 12 weeks.
Scapular-focused exerciseBehavioural
Scapular-focused exercise primarily targets the trapezius muscle, 60 minutes each session, once a week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| early (within 2 months post-surgery) referral groups. | Experimental | Not described Receives: Behavioral: Scapular-focused exercise |
| late (after 2 months post-surgery) referral groups | Active comparator | Not described Receives: Behavioral: Scapular-focused exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active range of motion (AROM) of shoulder abduction
Shoulder abduction AROM is measured in degrees three times using a universal goniometer and full-circle manual protractor, with the subject supine, shoulder in lateral rotation, and palm facing anteriorly. The protractor fulcrum is placed on the anterior acromial process, one arm aligned with the midline of the sternum, and the other with the anterior midline of the humerus, while keeping the thorax immobile to prevent vertebral lateral flexion.
Measured: Baseline (before the first exercise intervention), 12 weeks of exercise intervention
scapular position
The modified lateral scapular slide test (MLSST) measures the medio-lateral displacement of the inferior scapular angle and asymmetry at three shoulder abduction angles. The distance between the inferior scapular angle and the spinous process of the seventh thoracic vertebra is measured three times on each side using a vernier caliper, and the average difference is calculated. The MLSST is conducted in three positions: arms at the sides (position 1), hands on hips (position 2), and holding a 1 kg dumbbell at 90° shoulder abduction with maximal internal rotation in the scapular plane (position 3).
Measured: Baseline (before the first exercise intervention), 12 weeks of exercise intervention
Secondary outcomes (4)
ultrasonography of upper and middle trapezius morphology
For upper trapezius (UT) measurement, participants sit in a height-adjustable chair with back support, knees, and hips at 90°, feet on the floor, and hands resting on their thighs. The transducer is positioned parallel to the UT muscle at an oblique angle between C7 and the acromion, then moved laterally to capture the medial portion. For middle trapezius (MT) measurement, participants sit at the table edge with knees and hips at 90°, feet flat, and arms at their sides with elbows at 90° and palms down on a pillow. The transducer is placed over the middle third of a line between the acromion's posterolateral edge and the T1 spinous process, tilted forward and downward to visualize the MT's fascial borders.
Measured: Baseline (before the first exercise intervention), 12 weeks of exercise intervention
electromyography signals during maximum isometric contraction of the trapezius
EMG signals are recorded from the upper trapezius(UT), middle trapezius (MT), and lower trapezius (LT) at standardized landmarks. MVIC is measured before testing to prevent fatigue, with participants resisting manual force in UT, MT, and LT-specific positions, each followed by a 1-minute rest. During the task, participants sit with feet flat, holding a 1 kg dumbbell at 90° shoulder abduction with maximal internal rotation. They perform three repetitions, raising the arm in 3 seconds, holding for 5 seconds, and lowering in 3 seconds, with a 60-second rest between repetitions. Normalized RMS is expressed as %MVIC by averaging EMG data from the fifth second of each repetition and normalizing it to MVIC at 90° shoulder abduction.
Measured: Baseline (before the first exercise intervention), 12 weeks of exercise intervention
shoulder pain
Shoulder pain levels will be assessed during exercises using a 10-cm visual analog scale (VAS).
Measured: Baseline (before the first exercise intervention), 12 weeks of exercise intervention
upper extremity function
Upper extremity function is assessed using the Taiwan version of the DASH, a reliable 30-item self-report questionnaire where higher scores indicate greater disability.
Measured: Baseline (before the first exercise intervention), 12 weeks of exercise intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start25 Feb 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehabilitationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- early (within 2 months post-surgery) and late (after 2 months post-surgery) referral groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852261
- Sponsor's protocol ID
- 202412115RINA
- Status last verified
- Jul 2026
- First submitted
- 3 Feb 2025
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
- Comparison of Early Versus Late Referral for Scapular-Focused Exercise on Shoulder Function in Head and Neck Cancer Patients Following Neck Dissection
- ClinicalTrials.gov ID
- NCT06852261
- Acronym / sponsor ID
- 202412115RINA
- Conditions
- Rehabilitation
- Keywords
- shoulder, exercise, Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Feb 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.
This study aims to investigate the effects of comparing early versus late referrals for scapular-focused exercise on shoulder function in head and neck cancer patients following neck dissection.
Detailed description
This study will recruit 30 head and neck cancer patients with spinal accessory nerve shoulder dysfunction based on the timing of referral, which will be divided into early (within 2 months post-surgery) and late (after 2 months post-surgery) referral groups. Both groups will receive conventional physical therapy (e.g., shoulder joint mobility training, electrical stimulation, or laser therapy for pain relief) and scapular-focused exercises. Scapular-focused exercise primarily targets the trapezius muscle, 60 minutes each session, once a week for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- early (within 2 months post-surgery) and late (after 2 months post-surgery) referral groups
| Arm | Type | Receives |
|---|---|---|
| early (within 2 months post-surgery) referral groups. | Experimental | Behavioral: Scapular-focused exercise |
| late (after 2 months post-surgery) referral groups | Active comparator | Behavioral: Scapular-focused exercise |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 20 and 65 years.
- Newly diagnosed with head and neck cancer and experiencing clinical symptoms of accessory nerve dysfunction after unilateral neck dissection, such as shoulder drooping, restricted active range of motion in shoulder abduction, or insufficient muscle strength against gravity in shoulder abduction.
- Scapular dyskinesia, such as asymmetrical scapular movement in multiple planes.
- Scapular asymmetry, defined as a bilateral difference of more than 1.5 cm between the inferior angle of the scapula and the spinous process of the seventh thoracic vertebra when performing 90° shoulder abduction in the scapular plane under a 1 kg load.
Key exclusion criteria (5 listed)
- Presence of distant metastasis or cancer recurrence.
- Inability to communicate or comprehend the questionnaire.
- History of shoulder pain within one year before neck dissection.
- Any condition that may affect motor performance.
- History of neuromuscular disorders or tendon pathology in the affected shoulder, other than accessory nerve dysfunction.
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 |
|---|---|---|
| Scapular-focused exerciseScapular-focused exercise primarily targets the trapezius muscle, 60 minutes each session, once a week for 12 weeks. | Behavioural | early (within 2 months post-surgery) referral groups. |
| Scapular-focused exerciseScapular-focused exercise primarily targets the trapezius muscle, 60 minutes each session, once a week for 12 weeks. | Behavioural | late (after 2 months post-surgery) referral groups |
Primary outcome
Active range of motion (AROM) of shoulder abduction
Time frame: Baseline (before the first exercise intervention), 12 weeks of exercise intervention
Shoulder abduction AROM is measured in degrees three times using a universal goniometer and full-circle manual protractor, with the subject supine, shoulder in lateral rotation, and palm facing anteriorly. The protractor fulcrum is placed on the anterior acromial process, one arm aligned with the midline of the sternum, and the other with the anterior midline of the humerus, while keeping the thorax immobile to prevent vertebral lateral flexion.
scapular position
Time frame: Baseline (before the first exercise intervention), 12 weeks of exercise intervention
The modified lateral scapular slide test (MLSST) measures the medio-lateral displacement of the inferior scapular angle and asymmetry at three shoulder abduction angles. The distance between the inferior scapular angle and the spinous process of the seventh thoracic vertebra is measured three times on each side using a vernier caliper, and the average difference is calculated. The MLSST is conducted in three positions: arms at the sides (position 1), hands on hips (position 2), and holding a 1 kg dumbbell at 90° shoulder abduction with maximal internal rotation in the scapular plane (position 3).
4 secondary outcomes
ultrasonography of upper and middle trapezius morphology
Time frame: Baseline (before the first exercise intervention), 12 weeks of exercise intervention
electromyography signals during maximum isometric contraction of the trapezius
Time frame: Baseline (before the first exercise intervention), 12 weeks of exercise intervention
shoulder pain
Time frame: Baseline (before the first exercise intervention), 12 weeks of exercise intervention
upper extremity function
Time frame: Baseline (before the first exercise intervention), 12 weeks of exercise intervention
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.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scapular-focused exercise in people with Rehabilitation, run by National Taiwan University Hospital at 2 sites 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 4 inclusion and 5 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: under way, not looking for participants, 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 2 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Active range of motion (AROM) of shoulder abduction (time frame: Baseline (before the first exercise intervention), 12 weeks of exercise intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.