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

NCT01729065 | Completed

• 1 other identifier: 09-007403
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• SF-36

  12, 24, 36 weeks

Other Outcomes (2)

• Visual Analog Scale

  12, 24, 36 weeks

• Strength, range of motion of the neck and shoulder

  12, 24, 36 weeks

Study Arms (2)

Home Program

NO INTERVENTION

Participants perform home program only.

Physical Therapy Intervention

EXPERIMENTAL

Physical therapy intervention provided for first 12 weeks following surgery.

Other: Physical therapy intervention

Interventions

Physical therapy intervention OTHER

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

Physical Therapy Intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Melissa M Eden, PT, DPT

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist, Orthopedic Clinical Specialist, Primary Investigator

Study Record Dates

• First Submitted: November 9, 2012
• First Posted: November 20, 2012
• Study Start: January 1, 2010
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: May 22, 2015

Record last verified: 2015-05

Locations

US (1)