Photobiomodulation Therapy and Nerve Density for Patients With Diabetic or Chemotherapy-associated Neuropathy

Not Applicable

Completed

• Conditions: Neuropathy, Diabetic; Neuropathy Toxic; Neuropathy
• Interventions: Device: Realief Therapy

• Registration Number: NCT03195868
• Lead Sponsor: University of Minnesota

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.

Study Timeline

• Study First Submitted: 2017-06-01
• Study First Submitted QC: 2017-06-21
• Study First Posted: 2017-06-22
• Study Start: 2019-09-30
• Primary Completion: 2021-01-21
• Study Completion: 2021-01-21
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-07
• Last Update Posted: 2022-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

self reported neuropathy following exposure to diabetes or chemotherapy

• willingness to undergo biopsies and 6 weeks of therapy

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Exclusion Criteria

• pregnancy
• active cancer treatment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Photobiomodulation	Realief Therapy	All patients will be treated similarly in this study

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Brief Pain index	Change at Baseline 6 weeks, 26 weeks

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States