Using a diode laser to measure pain in peripheral neuropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to develop and validate a non-invasive biomarker for neuropathic pain caused by peripheral neuropathy. Participants will undergo a double-blind randomized crossover design, receiving either a lidocaine patch or a placebo, while their pain levels are monitored using a visual analogue scale. The study will utilize a diode laser to stimulate nerve fibers in the skin, measuring the sensory threshold and blood flow response to correlate with patient-reported pain. If successful, the findings could lead to improved methods for assessing and treating neuropathic pain.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Inclusion criteria for Objective 1 (Stanford)

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

Inclusion Criteria for Objective 2

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.

Inclusion Criteria for Objective 3

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

Exclusion Criteria:

Exclusion criteria Objective 1 (Stanford)

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)

Exclusion Criteria Objective 2 and 3

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.-

Where it's running

• Stanford University
  Palo Alto, California, United States Recruiting
• University of Utah
  Salt Lake City, Utah, United States Not yet recruiting

Study contacts

• Study coordinator: Cathy Revere
• Email: cathy.revere@hsc.utah.edu
• Phone: 8015585503

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.