Study Stopped
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PhysioTouch for Treatment of Radiation Fibrosis
The PhysioTouch, A Novel Treatment for Radiation Fibrosis Syndrome in Breast Cancer Patients
1 other identifier
interventional
N/A
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2018
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2018
CompletedFirst Posted
Study publicly available on registry
April 12, 2018
CompletedStudy Start
First participant enrolled
December 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2020
CompletedMarch 6, 2019
March 1, 2019
1.3 years
April 5, 2018
March 4, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Change in self-reported upper extremity function
Self-reported upper extremity function as measured by QuickDash
Baseline to 12 weeks
Change in self-reported pain
Self-reported upper extremity pain as measured by the BPI
Baseline to 12 weeks
Secondary Outcomes (2)
Change in affected shoulder abduction
Baseline to 12 weeks
Change in affected shoulder flexion
Baseline to 12 weeks
Study Arms (2)
Standard OT
ACTIVE COMPARATORPhysioTouch
EXPERIMENTALInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- History of radiation therapy for breast cancer
- Clinical or suspected RFS
- Reported functional impairments
You may not qualify if:
- Metastatic disease of soft tissue
- History of bilateral radiation therapy
- Previously diagnosed shoulder impairments not related to RFS
- Prior treatment with PhysioTouch
- Current or recent pregnancy
- Current breastfeeding
- Other contraindications to safe and meaningful participation at discretion of study team
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katie Rogers, MSOTR-CLT
Michigan Medicine, Department of Physical Medicine & Rehabiliation
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Occupational Therapist
Study Record Dates
First Submitted
April 5, 2018
First Posted
April 12, 2018
Study Start
December 1, 2018
Primary Completion
April 1, 2020
Study Completion
April 1, 2020
Last Updated
March 6, 2019
Record last verified: 2019-03