Spinal Cord Stimulation for Diabetic Peripheral Neuropathy

Spinal Cord Stimulation and Small Fiber Peripheral Neuropathy

Recruiting N/A Interventional Study
Diabetic Peripheral Neuropathy
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Other
Participants needed
60 (estimated)
Sponsor
Ohio State University · Other
Who this trial is looking for

This trial is looking for adults with diabetic peripheral neuropathy that hasn't improved with certain pain medications. Participants will receive spinal cord stimulation treatment and have their pain and nerve function measured before and after the treatment.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am over 18 years old.
  • I have been diagnosed with diabetic peripheral neuropathy that hasn't improved with gabapentin or pregabalin and at least one other pain medication.
  • I have chronic pain due to diabetic neuropathy.
  • I have had pain for at least 12 months.
  • My lower limb pain intensity score is 4 or higher.
  • I have a DN4 score of 4 or higher.
  • I can pass a pre-operative neuropsychological assessment.
  • I am able to give informed consent.

You may not be able to join if

  • I have severe medical problems that might stop me from having surgery.
  • I have spinal disease with severe spinal stenosis or spinal cord compression.
  • I have a bleeding disorder that can't be corrected.
  • I can't stop taking blood thinning medications.
  • My hemoglobin A1c level is greater than 10.
  • I have a systemic infection.
  • I am pregnant.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

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About This Trial

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. A time course of measurements before and after spinal cord stimulation (SCS) treatment (where applicable) will assess pain, DPN severity, small fiber nerve activity, and metabolic health markers.

Trial Locations
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Eligibility Criteria
Inclusion 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…
Contacts

Alexander Price

614-366-7822

Alexander.Price2@osumc.edu

CONTACT