PhysioTouch for Treatment of Radiation Fibrosis

Not Applicable

Withdrawn

• Conditions: Radiation Fibrosis
• Interventions: Behavioral: PhysioTouch; Behavioral: Standard OT

• Registration Number: NCT03496909
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-05
• Study First Submitted QC: 2018-04-05
• Study First Posted: 2018-04-12
• Study Start: 2018-12
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-04
• Last Update Posted: 2019-03-06
• Primary Completion: 2020-04
• Study Completion: 2020-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• History of radiation therapy for breast cancer
• Clinical or suspected RFS
• Reported functional impairments

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PhysioTouch	PhysioTouch	-
Standard OT	Standard OT	-

Primary Outcome Measures

Name	Time	Method
Change in self-reported pain	Baseline to 12 weeks	Self-reported upper extremity pain as measured by the BPI
Change in self-reported upper extremity function	Baseline to 12 weeks	Self-reported upper extremity function as measured by QuickDash

Secondary Outcome Measures

Name	Time	Method
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