An interventional study of Standard OT and PhysioTouch in Radiation Fibrosis, sponsored by University of Michigan. Withdrawn. Open to female participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-03-06.
Sponsored by University of Michigan · Not applicable, Interventional, and Treatment
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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.
19 studies on the registry are indexed under Radiation Fibrosis Syndrome; 6 are open to participants now.
Browse Radiation Fibrosis Syndrome studies →University of Michigan is the lead sponsor of 1,507 studies on the registry; 193 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Standard OT
Behavioral: PhysioTouch
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.
Change in self-reported upper extremity function
Self-reported upper extremity function as measured by QuickDash
Time frame: Baseline to 12 weeks
Change in self-reported pain
Self-reported upper extremity pain as measured by the BPI
Time frame: Baseline to 12 weeks
Change in affected shoulder abduction
Degrees of should abduction as measured by OT
Time frame: Baseline to 12 weeks
Change in affected shoulder flexion
Degrees of should flexsion as measured by OT
Time frame: Baseline to 12 weeks
No study locations are listed for this record.
Start is estimated for Dec 2018; primary completion for Apr 2020, 16 months later.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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