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New treatment option for Diabetic Peripheral Neuropathy
Official title Spinal Cord Stimulation and Small Fiber Peripheral Neuropathy
ClinicalTrials.gov ID: NCT06287736
What this study is testing
- What it's testing
- This is a prospective randomized control trial. Participants enrolled into the study will be randomized into one of three groups, two of which are treatment groups and the third is a control group.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Over 18 years old
- Diagnosis of diabetic peripheral neuropathy refractory to treatment with gabapentin or pregabalin and at least 1 other class of analgesic
- Diagnosis of medically refractory pain secondary to diabetic neuropathy
- Presence of pain for 12 months
- Lower limb pain intensity score ≥4 on a visual analog scale
You likely can't join if
- Severe medical comorbidities that, in the opinion of the surgeon, exclude the patient from surgical intervention
- Spinal disease with severe spinal stenosis or spinal cord compression in the region of the proposed spinal cord stimulator lead placement
- Coagulopathy that cannot be corrected
- Unable to discontinue blood thinning medications
- Hemoglobin A1c level greater than 10
- Presence of systemic infection
See the full eligibility criteria
- Over 18 years old
- Diagnosis of diabetic peripheral neuropathy refractory to treatment with gabapentin or pregabalin and at least 1 other class of analgesic
- Diagnosis of medically refractory pain secondary to diabetic neuropathy
- Presence of pain for 12 months
- Lower limb pain intensity score ≥4 on a visual analog scale
- DN4 ≥4
- Pass pre-operative neuropsychological assessment (surgical group only)
- Capable of providing informed consent
- Severe medical comorbidities that, in the opinion of the surgeon, exclude the patient from surgical intervention
- Spinal disease with severe spinal stenosis or spinal cord compression in the region of the proposed spinal cord stimulator lead placement
- Coagulopathy that cannot be corrected
- Unable to discontinue blood thinning medications
- Hemoglobin A1c level greater than 10
- Presence of systemic infection
- Pregnancy
The study team makes the final eligibility decision.
Where it's taking place
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.