Diode Laser as a Biomarker for Neuropathic Pain of Peripheral Origin.

Description

The R61 will perform a four-part double-blind randomized crossover study transitioning from a pretreatment baseline phase, to randomized treatment with either lidocaine or an identical placebo patch, washout, and alternate arm. DLss measures will be obtained before and after each phase. Twice daily report of pain using a visual analogue scale will track severity of ongoing spontaneous pain in participants. The hybrid biomarker will distinguish between placebo and active treatment arms, will significantly correlate with extent of neuropathic pain reduction during lidocaine, but will not change during the placebo phase or no-treatment lead-in. If preset Go/No-Go criteria are met, the subsequent R33 validation will then compare lidocaine patch and placebo treatment in a blinded, randomized parallel arm study.

Conditions

Peripheral Neuropathy

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Study Overview

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Study Details

Study overview

The R61 will perform a four-part double-blind randomized crossover study transitioning from a pretreatment baseline phase, to randomized treatment with either lidocaine or an identical placebo patch, washout, and alternate arm. DLss measures will be obtained before and after each phase. Twice daily report of pain using a visual analogue scale will track severity of ongoing spontaneous pain in participants. The hybrid biomarker will distinguish between placebo and active treatment arms, will significantly correlate with extent of neuropathic pain reduction during lidocaine, but will not change during the placebo phase or no-treatment lead-in. If preset Go/No-Go criteria are met, the subsequent R33 validation will then compare lidocaine patch and placebo treatment in a blinded, randomized parallel arm study.

Diode Laser as a Biomarker for Neuropathic Pain of Peripheral Origin.

Diode Laser as a Biomarker for Neuropathic Pain of Peripheral Origin.

Condition
Peripheral Neuropathy
Intervention / Treatment

-

Contacts and Locations

Palo Alto

Stanford University, Palo Alto, California, United States, 94305

Salt Lake City

University of Utah, Salt Lake City, Utah, United States, 84132

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. 18 -70 years of age
  • 2. no complaints of peripheral neuropathy or other foot pain
  • 3. no medical history of disease or medication use associated with peripheral neuropathy (e.g. diabetes)
  • 4. no known allergy to lidocaine
  • 1. . 18 years of age and older
  • 2. Length dependent, sensory predominant, peripheral neuropathy from any non-acute acquired cause (e.g. diabetes, pre-diabetes, chemotherapy induced), OR musculoskeletal pain from plantar fasciitis or ankle sprain.
  • 1. 18 years of age and older
  • 2. Length dependent, sensory predominant, peripheral neuropathy from any non-acute acquired cause (e.g. diabetes, pre-diabetes, chemotherapy induced) .
  • 3. Pain rating on Visual Analog Scale (VAS) \> 30mm
  • 1. complaints of peripheral neuropathy or other foot pain
  • 2. medical history of disease or medication use associated with peripheral neuropathy (e.g. diabetes)
  • 3. known allergy to lidocaine or other para-aminobenzioc acid derivative (ie: procaine, tetracaine, benzocaine)
  • 1. Acute peripheral neuropathy (e.g. Guillain Barre Syndrome, glucose correction neuropathy) because of concerns for stability of neuropathic pain over the period of study participation.
  • 2. Bleeding diathesis, or history of severe bleeding with skin wounds.
  • 3. known allergy to lidocaine or other para-aminobenzioc acid derivative (ie: procaine, tetracaine, benzocaine)
  • 4. Taking exclusionary medications related to lidocaine, or with anti-arrhythmic properties, such as tocainide or mexilitine.
  • 5. Severe liver disease
  • 6. People currently receiving chemotherapy.
  • 7. Unable to complete protocol requirements in the judgement of the investigator.-

Ages Eligible for Study

18 Years to 69 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Utah,

Study Record Dates

2025-08