This study seeks to determine if photobiomodulation (PBM, or low level laser light) affects the growth and distribution of nerves int he skin. Our previous study demonstrated that the treatment we use here was effective at reducing the symptoms of neuropathy (as measured by the modified total neuropathy score) in patients who had been treated with chemotherapy. The current effort is designed to repeat this confirm this observation using a more extensive battery of survey as well as to begin to elucidate the mechanism through which photobiomodulaiton produces the effect. WE will also be attempting to determine if diabetic patients differ in terms of response from chemotherapy patients
Consenting patients with self-reported neuropathy following either diabetes or administration of chemotherapy, will undergo sensory testing and skin biopsies of the the foot and leg prior to initiating treatment. They will undergo PBM 3 times weekly for 6 weeks with with a follow-up biopsy performed at the conclusion of therapy and sensory testing throughout. Patients will have one remote evaluation at 26 weeks to determine whether the effect, if any extinguishes.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Patients will be treated using class IV laser using a proprietary algorithm developed by REALief neuropathy centers
University of Minnesota
Minneapolis, Minnesota, United States
change in epidermal nerve density and/or distribution
nerve measures include epidermal penetration points
Time frame: Change at Baseline 6 weeks, 26 weeks
total nerve fiber density,
nerve measures
Time frame: Change at Baseline 6 weeks, 26 weeks
Brief Pain index
Time frame: Change at Baseline 6 weeks, 26 weeks
NTSS- Nueropathy Total Symptom Score
This is a 15 question survey with yes or no answers. Averaged for scoring
Time frame: Change at Baseline 6 weeks, 26 weeks
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