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Completed

NCT Number: NCT01729065

A Study to Assess the Efficacy of Early Physical Therapy Intervention 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.

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Key information

Conditions

Shoulder Weakness Following Neck Dissection Surgery Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Phoenix, Arizona, 85054, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical therapy intervention

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. SF-36

    Time frame: 12, 24, 36 weeks

    General health survey.

Other outcomes

  1. Visual Analog Scale

    Time frame: 12, 24, 36 weeks

    Pain Scale

  2. 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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Nov 20, 2012
Registry last updated
May 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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