RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-11-01
Study Completion:2025-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06030297

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.

Ages Eligible for Study:18 Years to 69 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 18 -70 years of age
  2. 2. no complaints of peripheral neuropathy or other foot pain
  3. 3. no medical history of disease or medication use associated with peripheral neuropathy (e.g. diabetes)
  4. 4. no known allergy to lidocaine
  5. 1. . 18 years of age and older
  6. 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.
  7. 1. 18 years of age and older
  8. 2. Length dependent, sensory predominant, peripheral neuropathy from any non-acute acquired cause (e.g. diabetes, pre-diabetes, chemotherapy induced) .
  9. 3. Pain rating on Visual Analog Scale (VAS) \> 30mm
  1. 1. complaints of peripheral neuropathy or other foot pain
  2. 2. medical history of disease or medication use associated with peripheral neuropathy (e.g. diabetes)
  3. 3. known allergy to lidocaine or other para-aminobenzioc acid derivative (ie: procaine, tetracaine, benzocaine)
  4. 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.
  5. 2. Bleeding diathesis, or history of severe bleeding with skin wounds.
  6. 3. known allergy to lidocaine or other para-aminobenzioc acid derivative (ie: procaine, tetracaine, benzocaine)
  7. 4. Taking exclusionary medications related to lidocaine, or with anti-arrhythmic properties, such as tocainide or mexilitine.
  8. 5. Severe liver disease
  9. 6. People currently receiving chemotherapy.
  10. 7. Unable to complete protocol requirements in the judgement of the investigator.-

Contacts and Locations

Study Contact

Cathy Revere
CONTACT
8015585503
cathy.revere@hsc.utah.edu

Study Locations (Sites)

Stanford University
Palo Alto, California, 94305
United States
University of Utah
Salt Lake City, Utah, 84132
United States

Collaborators and Investigators

Sponsor: University of Utah

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-01
Study Completion Date2025-08

Study Record Updates

Study Start Date2022-11-01
Study Completion Date2025-08

Terms related to this study

Keywords Provided by Researchers

  • Biomarker
  • neuropathic pain
  • response biomarker

Additional Relevant MeSH Terms

  • Peripheral Neuropathy