Study of Low Level Laser Therapy to Treat Diabetic Peripheral Neuropathy Foot Pain
- Conditions
- Diabetic Peripheral Neuropathy
- Registration Number
- NCT02461225
- Lead Sponsor
- Erchonia Corporation
- Brief Summary
The purpose of this study is to determine whether low level laser therapy is effective in the reduction of foot pain associated with diabetic peripheral neuropathy.
- Detailed Description
It is the goal of the current double-blind, placebo-controlled study to evaluate the efficacy of the Erchonia FX-635 which emits (3) 635nm red diodes, for providing temporary reduction of foot pain associated with diabetic peripheral neuropathy.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Existing clinical diagnosis of diabetes induced Peripheral Neuropathy documented by a suitably qualified and licensed medical professional
- Significant spontaneous foot pain that occurs approximately equally (comparably) bilaterally
- Significant spontaneous pain of 50 or greater on the 0-100 Visual Analog Scale (VAS) for the feet overall
- Foot pain is chronic, defined as having been ongoing for at least 3 months, bilaterally
- Stable anti-diabetic medication regimen for the prior 30 days or on no anti-diabetic medication regimen for the prior 30 days
- Willing and able to refrain from consuming any non-study over-the-counter and/or prescription medications or therapies for the relief of pain/inflammation throughout study participation
- Primary language is English.
- No definitive clinical diagnosis of diabetes induced Peripheral Neuropathy or foot pain is undiagnosed, or diagnosed as being other than, or in addition to, diabetes induced Peripheral Neuropathy
- Foot pain is unilateral or notably different between the two feet
- Self-reported Degree of Pain rating on the Visual Analog Scale (VAS) pain scale is less than 50 for both feet overall
- Serious organ disease or other serious primary disease merger
- Diabetes ketosis, ketoacidosis or severe infection within the past 2 weeks
- Current, active chronic pain disease
- Cancer or treatment for cancer in the past 6 months
- Use of any analgesics, or an equivalent of over-the counter or prescription NSAIDs (nonsteroidal anti-inflammatory drugs) within 7 days prior to study initiation
- Use of any antidepressants within 30 days prior to study initiation
- Use of any of the following prescription medications within 30 days prior to study initiation: Neurontin; Lyrica; Tramadol; Opioid medicines such as Ultram and Ultracet
- Injections of local anesthetics such as lidocaine within the past 30 days
- Surgical intervention to treat diabetic peripheral neuropathy foot pain, including implantation of a pain relief device
- Active infection, wound or other external trauma to the treatment areas
- Medical, physical, or other contraindications for, or sensitivity to, light therapy
- Pregnant, breast feeding, or planning pregnancy prior to the end of study participation
- Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in past two years
- Developmental disability or cognitive impairment that in the opinion of the investigator would preclude adequate comprehension of the consent form and/or ability to record study measurements
- Involvement in litigation/receiving disability benefits related to the parameters of the study
- Participation in other research in the past 30 days
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of Participants With a 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS) Baseline and 6 weeks The Visual Analog Scale (VAS) from baseline to endpoint (6 weeks) measurement is calculated for each subject. Individual subject success is defined as a 30% or greater change in VAS pain scores across the evaluation period. A negative (-) percent change indicates a decrease in pain level and is positive for individual subject success. A lower Visual Analog Scale pain score from baseline to study endpoint represents a better outcome, whereas a higher score from baseline to study endpoint represents a worse outcome.
For the primary study outcome, the overall study success is defined as a 35% or greater difference between the proportion (number) of individual successes in each treatment group.
- Secondary Outcome Measures
Name Time Method Change in Pain Rating on the Visual Analog Scale (VAS) Baseline and 6 weeks The Visual Analog Scale (VAS) assesses level or degree of pain. It is a horizontal line anchored on the left by the label '0: no pain at all' and on the right by the label '100: worst pain imaginable'. The subject marks a location on the 0-100 line that appears to represent any level of pain he or she is experiencing at that time. This marking is measured with a 0 to 100 mm ruler and the number recorded. A lower Visual Analog Scale pain score from baseline to study endpoint represents a better outcome, whereas a higher score from baseline to study endpoint represents a worse outcome.
Related Research Topics
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Trial Locations
- Locations (2)
Arizona Institute of Footcare Physicians
🇺🇸Mesa, Arizona, United States
Midleton Foot Clinic
🇮🇪Midleton, Co. Cork, Ireland
Arizona Institute of Footcare Physicians🇺🇸Mesa, Arizona, United States