Spinal Cord Stimulation in Chemotherapy Induced Neuropathy

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

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.

Study Overview

• Status: Completed
• Conditions: Chemotherapy-induced Peripheral Neuropathy
• Intervention / Treatment: Device: Spinal Cord Stimulator

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 Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

• Study Contact: Name: Joshua Smith, MD; Phone Number: (864) 522-5030; Email: PSmith9@ghs.org

Study Locations

• United States
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Patewood Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Primary Care Clinic

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Refusal to undergo a spinal cord stimulator procedure

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Spinal Cord Stimulator - Permanent Implantation	Device: Spinal Cord Stimulator; Permanent Implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Permanent Spinal Cord Stimulator Implantation	To determine the total number of patients who undergo permanent spinal cord stimulator implantation.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Pain Assessment: Brief Pain Inventory-Short Form	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.	2 years
Subjective Quality of Life Assessment: Pittsburgh Sleep Quality Assessment	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.	2 years

Collaborators and Investigators

• Sponsor: Prisma Health-Upstate
• Investigators: Principal Investigator: Joshua Smith, MD, Prisma Health-Upstate

Publications and helpful links

General Publications

• Braun Filho JL, Braun LM. [Spinal cord stimulation in the treatment of refractory painful polineuropathy induced by chemotherapy.]. Rev Bras Anestesiol. 2007 Oct;57(5):533-8. doi: 10.1590/s0034-70942007000500008. Portuguese.

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2018
• Primary Completion (Actual): May 3, 2022
• Study Completion (Actual): May 3, 2022

Study Registration Dates

• First Submitted: December 3, 2018
• First Submitted That Met QC Criteria: December 4, 2018
• First Posted (Actual): December 5, 2018

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: Pro00076097

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes