Diabetic Peripheral Neuropathy
Conditions
Brief summary
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.
Detailed description
Peripheral neuropathy (PN) is caused by diabetes, aging, chemotherapy, and over 30 other conditions, and impacts more than 30 million patients in the US alone. Diabetes is the number one cause of peripheral neuropathy, and more than half of patients with diabetes will eventually develop diabetic peripheral neuropathy (DPN), a complex set of symptoms including pain, numbness, tingling, and burning. Spinal cord stimulation (SCS) is an approved intervention for the treatment of chronic pain, including DPN. Spinal cord stimulation has had FDA approval for the treatment of painful DPN since 2015. This study is being done to learn more about the diagnosis of DPN and treatment of DPN with SCS.
Interventions
DEVICESpinal Cord Stimulator Implantation (SCS)
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
Sponsors
Ohio State University
Neuright, Inc.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain level | 18 months post baseline | change in Visual analog pain scale (VAS). The VAS endpoints range from 'no pain at all' to 'pain as bad as it could be' |
| Change in Diabetic Peripheral Neuropathy (DPN) Pain using the Neuropathic pain diagnostic questionnaire (DN4) | 18 months post baseline | 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 |
| Change in PROMIS quality of life in relation to pain level | 18 months post baseline | Change in patient-reported outcomes measurement (PROMIS 29) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in neuropathic symptoms using Michigan Neuropathy Screening instrument | 18 months post baseline | 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. |
Countries
United States
Contacts
CONTACTAlexander Price
PRINCIPAL_INVESTIGATORBrian Dalm, MD
Ohio State University
Outcome results
None listed