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A Study to Assess the Efficacy of Early Physical Therapy Intervention Following a Modified Unilateral Neck Dissection for Treatment of Head and Neck Cancer

A Randomized Study to Assess the Efficacy of Early Physical Therapy Intervention on Upper Quarter Strength and Mobility, and Reported Upper Extremity Disability and Quality of Life Measures Following a Modified Unilateral Neck Dissection for Treatment of Head and Neck Cancer

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01729065
Enrollment
50
Registered
2012-11-20
Start date
2010-01-31
Completion date
2015-05-31
Last updated
2015-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Weakness Following Neck Dissection Surgery

Keywords

Spinal Accessory Nerve Palsy, Cranial Nerve XI, shoulder weakness, neck stiffness, head and neck cancer, neck dissection

Brief summary

This study will determine whether patients who receive regular physical therapy immediately following a modified neck dissection surgery will report decreased shoulder disability, decreased pain, improved or maintained shoulder range of motion and strength, and improved quality of life than those who receive only home instruction.

Interventions

Exercises addressing cervical range of motion, shoulder range of motion and strengthening and scapular stabilization.

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* Adults age 18-85, able to give informed consent * Subject has provided written informed consent * Received Modified Unilateral Neck Dissection with sparing of the SAN * Not currently using transcutaneous electrical nerve stimulation (TENS) as a pain relieving modality * Not currently receiving acupuncture as a pain relieving modality * Able to participate with treatment group protocol including physical therapy appointment every other week

Exclusion criteria

* History of prior shoulder injury or surgery including rotator cuff repair or total shoulder arthroplasty. * History of CVA with hemi paresis * Bilateral neck dissection * Known severed SAN

Design outcomes

Primary

MeasureTime frameDescription
Disability of the Arm Shoulder and Hand12, 24, 36 weeksA standardized outcome tool which will be used to measure change in the level of disability related to involvement of the upper extremity at 12, 24, and 36 weeks compared to baseline.

Secondary

MeasureTime frameDescription
SF-3612, 24, 36 weeksGeneral health survey.

Other

MeasureTime frameDescription
Visual Analog Scale12, 24, 36 weeksPain Scale
Strength, range of motion of the neck and shoulder12, 24, 36 weeksMeasurements of shoulder range of motion and strength, cervical range of motion

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026