Using spinal cord stimulation to treat diabetic 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 clinical trial is a prospective randomized control trial that aims to evaluate the effectiveness of spinal cord stimulation (SCS) in treating diabetic peripheral neuropathy (DPN). Participants will be randomly assigned to one of three groups: two treatment groups receiving SCS and one control group. The study will measure pain levels, DPN severity, small fiber nerve activity, and metabolic health markers before and after the SCS treatment. The goal is to gather more information on the diagnosis and treatment of DPN using SCS.

Why it matters

Who can join: the full rules

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 pain intensity score ≥4 on a visual analog scale
* DN4 ≥4
* Pass pre-operative neuropsychological assessment (surgical group only)
* Capable of providing informed consent

Exclusion Criteria:

* 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

Where it's running

• The Ohio State University Wexner Medical Center
  Columbus, Ohio, United States Recruiting

Study contacts

• Principal investigator: Brian Dalm, MD — Ohio State University
• Study coordinator: Alexander Price
• Email: Alexander.Price2@osumc.edu
• Phone: 614-366-7822

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Effects of perturbation-based balance training vs conventional balance training for reactive stepping in adults with diabetic nerve damage

  A 40-person study will test whether adding perturbation-based balance training helps adults with diabetic peripheral neuropathy react better to balance threats compared with standard balance training.

  Recruiting Lahore University of Biological and Applied Sciences · Lahore, Punjab Province · NCT07902297

• Ultrasound-guided nerve hydrodissection for diabetic leg nerves

  A single ultrasound-guided nerve hydrodissection procedure is tested to see if it helps people with diabetic lower limb entrapment neuropathy feel less pain and have better nerve function.

  Recruiting Chongqing Medical University · Chongqing, Chongqing Municipality · NCT07625020

• Shortwave therapy for diabetic peripheral neuropathy

  A one-center study will test whether shortwave therapy given for five days can improve nerve symptoms in adults with diabetic neuropathy compared to a sham treatment.

  Recruiting Chongqing Medical University · Chongqing · NCT07625007

• MinION sequencing to identify microbes in diabetic foot bone infections

  This study will test a rapid MinION DNA sequencing method to identify bacteria, fungi, and resistance genes in infected diabetic foot wounds and compare the results with standard culture.

  Recruiting Centre Hospitalier Universitaire de Nīmes · Nîmes, Gard · NCT07391995

• Intraneural Facilitation and Otago Exercise for Diabetic Peripheral Neuropathy

  This study will test whether intraneural facilitation, the Otago exercise program, or a combination of both can improve balance, reduce neuropathic pain, and improve quality of life for people aged 50–75 with diabetic peripheral neuropathy.

  Recruiting Riphah International University · Lahore, Punjab Province · NCT07274735

• Topical Capsadyn (palmitated capsaicin) for diabetic neuropathic foot pain

  This study will test whether a topical Capsadyn cream can reduce foot pain in adults with diabetic peripheral neuropathy.

  Recruiting Early Phase 1 Carilion Clinic · Roanoke, Virginia · NCT07260656

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.