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

Study 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.

Official Title
-----------------
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

Conditions
-----------------
Shoulder Weakness Following Neck Dissection Surgery

Intervention / Treatment
-----------------
* Other: Physical therapy intervention


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Home Program<br>Participants perform home program only. | |
| Experimental: Physical Therapy Intervention<br>Physical therapy intervention provided for first 12 weeks following surgery. | Other: Physical therapy intervention<br>* Exercises addressing cervical range of motion, shoulder range of motion and strengthening and scapular stabilization.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability of the Arm Shoulder and Hand | 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. | 12, 24, 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-36 | General health survey. | 12, 24, 36 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal Accessory Nerve Palsy, Cranial Nerve XI, shoulder weakness, neck stiffness, head and neck cancer, neck dissection