Spinal Cord Stimulation in Chemotherapy Induced Neuropathy

Completed

• Conditions: Chemotherapy-induced Peripheral Neuropathy
• Interventions: Device: Spinal Cord Stimulator

• Registration Number: NCT03764514
• Lead Sponsor: Prisma Health-Upstate

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.

Study Timeline

• Study Start: 2018-12-03
• Study First Submitted: 2018-12-03
• Study First Submitted QC: 2018-12-04
• Study First Posted: 2018-12-05
• Primary Completion: 2022-05-03
• Study Completion: 2022-05-03
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

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

Exclusion Criteria

• Refusal to undergo a spinal cord stimulator procedure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Spinal Cord Stimulator - Permanent Implantation	Spinal Cord Stimulator	-

Primary Outcome Measures

Name	Time	Method
Permanent Spinal Cord Stimulator Implantation	2 years	To determine the total number of patients who undergo permanent spinal cord stimulator implantation.

Secondary Outcome Measures

Name	Time	Method
Subjective Quality of Life Assessment: Pittsburgh Sleep Quality Assessment	2 years	Measure quality of life through the use of the Pittsburgh Sleep Quality Assessment. The Pittsburgh Sleep Quality Index is a 19-item, self-rated questionnaire designed to measure sleep quality and disturbance over the past month in clinical populations.The 19 items are grouped into 7 components, including (1) sleep duration, (2) sleep disturbance, (3) sleep latency, (4) daytime dysfunction due to sleepiness, (5) sleep efficiency, (6) overall sleep quality, and (7) sleep medication use. Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (global score) indicating worse sleep quality.
Subjective Pain Assessment: Brief Pain Inventory-Short Form	2 years	Measure Pain with the Brief Pain Inventory-Short Form. The scale measures the severity of pain and the impact of pain on daily functions. The scale range includes 0-10 scales, with 0=no interference and 10=interferes completely. There is not a scoring algorithm, but "worst pain" or the average of the four severity items can be used as measures of pain severity; the average of the seven interference items can be used as a measure of pain interference.

Trial Locations

Locations (1)

Patewood Memorial Hospital; 🇺🇸 Greenville, South Carolina, United States