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Spinal Cord Stimulation and Small Fiber Peripheral Neuropathy

ConditionDiabetic Peripheral Neuropathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOhio State University

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Spinal Cord Stimulator Implantation (SCS)

    Device

    Spinal cord stimulator implantation is broken up into two parts. The first part involves placement of temporary SCS leads for a one-week trial. If the participants respond favorably to the SCS, then they will undergo the second part and the device is implanted

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Conventional Medical Management (CMM). Group1No intervention 0 interventions
Group B: Spinal Cord Stimulator (SCS) immediate activation. Group 2Active comparator 1 intervention
Group C: Spinal Cord Stimulator (SCS) Delayed activation. Group 3Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Pain level

change in Visual analog pain scale (VAS). The VAS endpoints range from 'no pain at all' to 'pain as bad as it could be'

Time frame
18 months post baseline
2

Change in Diabetic Peripheral Neuropathy (DPN) Pain using the Neuropathic pain diagnostic questionnaire (DN4)

Neuropathic Pain Diagnostic "Douleur Neuropathique 4" questionnaire (DN4) is a screening questionnaire to help identify neuropathic pain (NP) in clinical practice and research. It is a clinican-administered questionnaire consisting of 10 items.The first 7 symptoms items are scored by interviewing the patient, and the 3 remaining items are scored by means of clinical examination. The scores are added and a score of 4 or more out of 10 is suggestive of neuropathic pain

Time frame
18 months post baseline
3

Change in PROMIS quality of life in relation to pain level

Change in patient-reported outcomes measurement (PROMIS 29)

Time frame
18 months post baseline

Secondary outcomes

1

change in neuropathic symptoms using Michigan Neuropathy Screening instrument

change in Michigan Neuropathy Screening instrument (MNSI). The MNSI is designed to be used in the outpatient setting. The MNSI is broken up into 2 parts. The first part consists of 15 yes/no questions on foot sensation. The highest score is 13, and the higher the score indicates more neuropathic symptoms.

Time frame
18 months post baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ohio State University

Lead sponsor

Neuright, Inc.

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov
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