Radiation Fibrosis
Conditions
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.
Interventions
BEHAVIORALStandard 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.
BEHAVIORALPhysioTouch
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
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* History of radiation therapy for breast cancer * Clinical or suspected RFS * Reported functional impairments
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in self-reported upper extremity function | Baseline to 12 weeks | Self-reported upper extremity function as measured by QuickDash |
| Change in self-reported pain | Baseline to 12 weeks | Self-reported upper extremity pain as measured by the BPI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in affected shoulder abduction | Baseline to 12 weeks | Degrees of should abduction as measured by OT |
| Change in affected shoulder flexion | Baseline to 12 weeks | Degrees of should flexsion as measured by OT |
Outcome results
None listed