Clinical trial NCT06852261: Early vs. Late Referral for Scapular Exercises in Shoulder Function After Neck Dissection
Official title: Comparison of Early Versus Late Referral for Scapular-Focused Exercise on Shoulder Function in Head and Neck Cancer Patients Following Neck Dissection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rehabilitation
Keywords: shoulder
exercise
Head and Neck Cancer
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: early (within 2 months post-surgery) and late (after 2 months post-surgery) referral groups
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria

1. Age between 20 and 65 years.
2. 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.
3. Scapular dyskinesia, such as asymmetrical scapular movement in multiple planes.
4. 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.

Exclusion Criteria：

1. Presence of distant metastasis or cancer recurrence.
2. Inability to communicate or comprehend the questionnaire.
3. History of shoulder pain within one year before neck dissection.
4. Any condition that may affect motor performance.
5. History of neuromuscular disorders or tendon pathology in the affected shoulder, other than accessory nerve dysfunction.

Primary outcomes:
measure: Active range of motion (AROM) of shoulder abduction
timeFrame: Baseline (before the first exercise intervention), 12 weeks of exercise intervention
measure: scapular position
timeFrame: Baseline (before the first exercise intervention), 12 weeks of exercise intervention
Secondary outcomes:
measure: ultrasonography of upper and middle trapezius morphology
timeFrame: Baseline (before the first exercise intervention), 12 weeks of exercise intervention
measure: electromyography signals during maximum isometric contraction of the trapezius
timeFrame: Baseline (before the first exercise intervention), 12 weeks of exercise intervention
measure: shoulder pain
timeFrame: Baseline (before the first exercise intervention), 12 weeks of exercise intervention
measure: upper extremity function
timeFrame: Baseline (before the first exercise intervention), 12 weeks of exercise intervention
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan Univerisity Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: