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PhysioTouch for Treatment of Radiation Fibrosis

NCT03496909 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-03-06

No results posted yet for this study

Summary

A quarter of a million women will develop breast cancer (BC) in this year alone. Many of these women will have side effects as a result of their breast cancer treatment. Radiation Fibrosis Syndrome (RFS) is a common complication from breast cancer treatment that progressively changes tissue and can cause decreased function, pain, and range of motion. The PhysioTouch is a hand held device that can be used to treat RFS and may improve the treatment of fibrotic tissue. This pilot randomized controlled trial aims to determine the efficacy of using the PhysioTouch in addition to current standard of care for treatment of BC-related RFS.

Conditions

  • Radiation Fibrosis

Interventions

BEHAVIORAL

Standard OT

12 weekly sessions of occupational therapy tailored to patients with RFS secondary to breast cancer treatment. Sessions can include manual therapy, education, and active and passive range-of-motion, etc.

BEHAVIORAL

PhysioTouch

12 weekly sessions of occupational therapy tailored to patients with RFS secondary to breast cancer treatment. Sessions can include use of the PhysioTouch electronic massager in lieu of manual therapy, education, and active and passive range-of-motion, etc.

Sponsors & Collaborators

Principal Investigators

  • Katie Rogers, MSOTR-CLT · Michigan Medicine, Department of Physical Medicine & Rehabiliation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-31
Primary Completion
2020-04-30
Completion
2020-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03496909 on ClinicalTrials.gov