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

NCT ID: NCT01729065

Last Updated: 2015-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2015-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Shoulder Weakness Following Neck Dissection Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Home Program

Participants perform home program only.

Group Type NO_INTERVENTION

No interventions assigned to this group

Physical Therapy Intervention

Physical therapy intervention provided for first 12 weeks following surgery.

Group Type EXPERIMENTAL

Physical therapy intervention

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Physical therapy intervention

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Melissa M. Eden

Physical Therapist, Orthopedic Clinical Specialist, Primary Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Melissa M Eden, PT, DPT

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mayo Clinic

Phoenix, Arizona, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

09-007403

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.