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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK138849-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Neuright, Inc. | UNKNOWN |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Medical Management (CMM). Group1 | No Intervention | ||
| Spinal Cord Stimulator (SCS) immediate activation. Group 2 | Active Comparator |
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| Spinal Cord Stimulator (SCS) Delayed activation. Group 3 | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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' | 18 months post baseline |
| 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 | 18 months post baseline |
| Change in PROMIS quality of life in relation to pain level | Change in patient-reported outcomes measurement (PROMIS 29) | 18 months post baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 18 months post baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexander Price | Contact | 614-366-7822 | Alexander.Price2@osumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Brian Dalm, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Wexner Medical Center | Recruiting | Columbus | Ohio | 43210 | United States |
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