Status:
UNKNOWN
Diode Laser as a Biomarker for Neuropathic Pain of Peripheral Origin.
Lead Sponsor:
University of Utah
Collaborating Sponsors:
Stanford University
National Institutes of Health (NIH)
Conditions:
Peripheral Neuropathy
Eligibility:
All Genders
18-69 years
Phase:
NA
Brief Summary
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, ...
Detailed Description
Pain caused by peripheral neuropathy is very common. Understanding patient response to pain and its treatment is one of the biggest barriers to development of effective medicines to reduce neuropathic...
Eligibility Criteria
Inclusion
- Inclusion criteria for Objective 1 (Stanford)
- 18 -70 years of age
- no complaints of peripheral neuropathy or other foot pain
- no medical history of disease or medication use associated with peripheral neuropathy (e.g. diabetes)
- no known allergy to lidocaine
- Inclusion Criteria for Objective 2
- . 18 years of age and older
- 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
- 18 years of age and older
- Length dependent, sensory predominant, peripheral neuropathy from any non-acute acquired cause (e.g. diabetes, pre-diabetes, chemotherapy induced) .
- Pain rating on Visual Analog Scale (VAS) \> 30mm
Exclusion
- Exclusion criteria Objective 1 (Stanford)
- complaints of peripheral neuropathy or other foot pain
- medical history of disease or medication use associated with peripheral neuropathy (e.g. diabetes)
- known allergy to lidocaine or other para-aminobenzioc acid derivative (ie: procaine, tetracaine, benzocaine)
- Exclusion Criteria Objective 2 and 3
- 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.
- Bleeding diathesis, or history of severe bleeding with skin wounds.
- 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.-
Key Trial Info
Start Date :
November 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
301 Patients enrolled
Trial Details
Trial ID
NCT06030297
Start Date
November 1 2022
End Date
August 1 2025
Last Update
September 8 2023
Active Locations (2)
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1
Stanford University
Palo Alto, California, United States, 94305
2
University of Utah
Salt Lake City, Utah, United States, 84132