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

May 21, 2015 updated by: Melissa M. Eden, Mayo Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12, 24, 36 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: 12, 24, 36 weeks
Pain Scale
12, 24, 36 weeks
Strength, range of motion of the neck and shoulder
Time Frame: 12, 24, 36 weeks
Measurements of shoulder range of motion and strength, cervical range of motion
12, 24, 36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Melissa M Eden, PT, DPT, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

November 9, 2012

First Submitted That Met QC Criteria

November 13, 2012

First Posted (Estimate)

November 20, 2012

Study Record Updates

Last Update Posted (Estimate)

May 22, 2015

Last Update Submitted That Met QC Criteria

May 21, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-007403

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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