Neuropathy, Neuropathy, Diabetic, Neuropathy Toxic
Conditions
Keywords
chemotherapy, chemo-induced, CIPN
Brief summary
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
Detailed description
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.
Interventions
DEVICERealief Therapy
Patients will be treated using class IV laser using a proprietary algorithm developed by REALief neuropathy centers
Sponsors
University of Minnesota
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single group, prospective cohort
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
self reported neuropathy following exposure to diabetes or chemotherapy * willingness to undergo biopsies and 6 weeks of therapy
Exclusion criteria
* pregnancy * active cancer treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in epidermal nerve density and/or distribution | Change at Baseline 6 weeks, 26 weeks | nerve measures include epidermal penetration points |
| total nerve fiber density, | Change at Baseline 6 weeks, 26 weeks | nerve measures |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain index | Change at Baseline 6 weeks, 26 weeks | — |
| NTSS- Nueropathy Total Symptom Score | Change at Baseline 6 weeks, 26 weeks | This is a 15 question survey with yes or no answers. Averaged for scoring |
Countries
United States
Outcome results
None listed