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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


N/A
18 Years
85 Years
Open (Enrolling)
Both
Shoulder Weakness Following Neck Dissection Surgery

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disability of the Arm Shoulder and Hand

Outcome Description:

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.

Outcome Time Frame:

12, 24, 36 weeks

Safety Issue:

No

Principal Investigator

Melissa M Eden, PT, DPT

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Institutional Review Board

Study ID:

09-007403

NCT ID:

NCT01729065

Start Date:

January 2010

Completion Date:

January 2014

Related Keywords:

  • Shoulder Weakness Following Neck Dissection Surgery
  • Spinal Accessory Nerve Palsy, Cranial Nerve XI, shoulder weakness, neck stiffness, head and neck cancer, neck dissection
  • Asthenia
  • Head and Neck Neoplasms

Name

Location

Mayo ClinicScottsdale, Arizona