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

Not Applicable

Completed

• Conditions: Shoulder Weakness Following Neck Dissection Surgery
• Interventions: Other: Physical therapy intervention

• Registration Number: NCT01729065
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2012-11-09
• Study First Submitted QC: 2012-11-13
• Study First Posted: 2012-11-20
• Status Verified: 2015-05
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Last Update Submitted: 2015-05-21
• Last Update Posted: 2015-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical Therapy Intervention	Physical therapy intervention	Physical therapy intervention provided for first 12 weeks following surgery.

Primary Outcome Measures

Name	Time	Method
Disability of the Arm Shoulder and Hand	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 Outcome Measures

Name	Time	Method
SF-36	12, 24, 36 weeks	General health survey.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Phoenix, Arizona, United States