Early vs. Late Referral for Scapular Exercises in Shoulder Function After Neck Dissection

NCT06852261 | Recruiting

• 1 other identifier: 202412115RINA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Rehabilitation

Keywords

shoulder; exercise; Head and Neck Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  Baseline (before the first exercise intervention), 12 weeks of exercise intervention

Secondary Outcomes (4)

• ultrasonography of upper and middle trapezius morphology

  Baseline (before the first exercise intervention), 12 weeks of exercise intervention

• electromyography signals during maximum isometric contraction of the trapezius

  Baseline (before the first exercise intervention), 12 weeks of exercise intervention

• shoulder pain

  Baseline (before the first exercise intervention), 12 weeks of exercise intervention

• upper extremity function

  Baseline (before the first exercise intervention), 12 weeks of exercise intervention

Study Arms (2)

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

Interventions

Scapular-focused exercise BEHAVIORAL

Scapular-focused exercise primarily targets the trapezius muscle, 60 minutes each session, once a week for 12 weeks.

early (within 2 months post-surgery) referral groups.

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (2)

National Taiwan Univerisity Hospital

Taipei, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Motor Activity; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Behavior; Neoplasms by Site; Neoplasms

Central Study Contacts

CHIN-YIN YU

CONTACT

+886 953 581 006; fish706014@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: early (within 2 months post-surgery) and late (after 2 months post-surgery) referral groups

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 28, 2025
• Study Start: February 25, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 21, 2025

Record last verified: 2025-02

Locations

TW (2)