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

Neuropathy Clinical Trial

Official title:

A Comparative Analysis of Changes in Peripheral Nerve Density and Structure Following Photobiomodulation Therapy Using the REALief Therapy System for Patients With Diabetic or Chemotherapy-associated Neuropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03195868
• Other study ID #: 2017NTLS037
• Status: Completed
• Phase: N/A
• Start date: September 30, 2019
• Est. completion date: January 21, 2021

Study information

• Verified date: June 2022
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 21, 2021
• Est. primary completion date: January 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Neuropathy
• Neuropathy Toxic
• Neuropathy, Diabetic
• Peripheral Nervous System Diseases

Intervention

Device:
• Realief Therapy
Patients will be treated using class IV laser using a proprietary algorithm developed by REALief neuropathy centers

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

References & Publications (1)

Argenta PA, Ballman KV, Geller MA, Carson LF, Ghebre R, Mullany SA, Teoh DG, Winterhoff BJ, Rivard CL, Erickson BK. The effect of photobiomodulation on chemotherapy-induced peripheral neuropathy: A randomized, sham-controlled clinical trial. Gynecol Oncol. 2017 Jan;144(1):159-166. doi: 10.1016/j.ygyno.2016.11.013. Epub 2016 Nov 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in epidermal nerve density and/or distribution	nerve measures include epidermal penetration points	Change at Baseline 6 weeks, 26 weeks
Primary	total nerve fiber density,	nerve measures	Change at Baseline 6 weeks, 26 weeks
Secondary	Brief Pain index		Change at Baseline 6 weeks, 26 weeks
Secondary	NTSS- Nueropathy Total Symptom Score	This is a 15 question survey with yes or no answers. Averaged for scoring	Change at Baseline 6 weeks, 26 weeks