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

Primary Purpose

Shoulder Weakness Following Neck Dissection Surgery

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Physical therapy intervention

About this trial

This is an interventional treatment trial for Shoulder Weakness Following Neck Dissection Surgery focused on measuring Spinal Accessory Nerve Palsy, Cranial Nerve XI, shoulder weakness, neck stiffness, head and neck cancer, neck dissection

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Home Program

Physical Therapy Intervention

Arm Description

Participants perform home program only.

Physical therapy intervention provided for first 12 weeks following surgery.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

SF-36

General health survey.

Full Information

NCT ID

NCT01729065

First Posted

November 9, 2012

Last Updated

May 21, 2015

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT01729065

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Shoulder Weakness Following Neck Dissection Surgery

Keywords

Spinal Accessory Nerve Palsy, Cranial Nerve XI, shoulder weakness, neck stiffness, head and neck cancer, neck dissection

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Home Program

Arm Type

No Intervention

Arm Description

Participants perform home program only.

Arm Title

Physical Therapy Intervention

Arm Type

Experimental

Arm Description

Physical therapy intervention provided for first 12 weeks following surgery.

Intervention Type

Other

Intervention Name(s)

Physical therapy intervention

Intervention Description

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

Primary Outcome Measure Information:

Title

Disability of the Arm Shoulder and Hand

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.

Time Frame

12, 24, 36 weeks

Secondary Outcome Measure Information:

Title

SF-36

Description

General health survey.

Time Frame

12, 24, 36 weeks

Other Pre-specified Outcome Measures:

Title

Visual Analog Scale

Description

Pain Scale

Time Frame

12, 24, 36 weeks

Title

Strength, range of motion of the neck and shoulder

Description

Measurements of shoulder range of motion and strength, cervical range of motion

Time Frame

12, 24, 36 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Melissa M Eden, PT, DPT

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85054

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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