NCT03764514

Spinal Cord Stimulation in Chemotherapy Induced Neuropathy

Effectiveness of Spinal Cord Stimulation As Therapy for Chemotherapy-Induced Peripheral Neuropathy: a Pilot Trial

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 5 (actual)
• Sponsor: Prisma Health-Upstate · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is an observational based pilot study evaluating the use of spinal cord stimulators for the treatment of chemotherapy induced peripheral neuropathy will lead to an increase in quality of life and decrease in pain.

Detailed description

Cancer treatment, for many patients, results in painful side effects. As evidence mounts demonstrating the risks associated with long term opioid therapy, non-opioid modalities need to be developed. Spinal cord stimulators are implanted devices that modulate the pain signaling system in the spinal cord. This research hopes to determine if the use of a spinal cord stimulator in patients with chemotherapy induced peripheral neuropathy will lead to an increase in quality of life and decrease in pain.The primary endpoints will be the number of patients who undergo permanent implantation. The endpoints will measure pain with the Brief Pain Inventory Short Form visual analog scale. The sleep quality will be measured using the Pittsburgh Sleep Quality Assessment.

Conditions

• Chemotherapy-induced Peripheral Neuropathy

Interventions

Type	Name	Description
DEVICE	Spinal Cord Stimulator	Permanent Implantation

Timeline

• Start date: 2018-12-03
• Primary completion: 2022-05-03
• Completion: 2022-05-03
• First posted: 2018-12-05
• Last updated: 2024-09-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study