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Clinical Trials/NCT03764514
NCT03764514
Completed
Not Applicable

Effectiveness of Spinal Cord Stimulation as Therapy for Chemotherapy-Induced Peripheral Neuropathy: A Pilot Trial

Prisma Health-Upstate1 site in 1 country5 target enrollmentDecember 3, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chemotherapy-induced Peripheral Neuropathy
Sponsor
Prisma Health-Upstate
Enrollment
5
Locations
1
Primary Endpoint
Permanent Spinal Cord Stimulator Implantation
Status
Completed
Last Updated
3 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
December 3, 2018
End Date
May 3, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • The patient has persistent, severe peripheral neuropathy secondary to chemotherapy

Exclusion Criteria

  • Refusal to undergo a spinal cord stimulator procedure

Outcomes

Primary Outcomes

Permanent Spinal Cord Stimulator Implantation

Time Frame: 2 years

To determine the total number of patients who undergo permanent spinal cord stimulator implantation.

Secondary Outcomes

  • Subjective Quality of Life Assessment: Pittsburgh Sleep Quality Assessment(2 years)
  • Subjective Pain Assessment: Brief Pain Inventory-Short Form(2 years)

Study Sites (1)

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