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

Mayo Clinic1 site in 1 country50 target enrollmentJanuary 2010

ConditionsShoulder Weakness Following Neck Dissection Surgery

Overview

Phase: N/A
Intervention: Not specified
Conditions: Shoulder Weakness Following Neck Dissection Surgery
Sponsor: Mayo Clinic
Enrollment: 50
Locations: 1
Primary Endpoint: Disability of the Arm Shoulder and Hand
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2010

End Date

May 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Mayo Clinic

Responsible Party

Principal Investigator

Melissa M. Eden

Physical Therapist, Orthopedic Clinical Specialist, Primary Investigator

Mayo Clinic

Eligibility Criteria

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

Outcomes

Primary Outcomes

Disability of the Arm Shoulder and Hand

Time Frame: 12, 24, 36 weeks

A 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.