Spinal Cord Stimulation in Chemotherapy Induced Neuropathy

Overview

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.

Full Title of Study: “Effectiveness of Spinal Cord Stimulation as Therapy for Chemotherapy-Induced Peripheral Neuropathy: A Pilot Trial”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 3, 2022

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.

Interventions

  • Device: Spinal Cord Stimulator
    • Permanent Implantation

Arms, Groups and Cohorts

  • Spinal Cord Stimulator – Permanent Implantation

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Subjective Pain Assessment: Brief Pain Inventory-Short Form
    • Time Frame: 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.
  • Subjective Quality of Life Assessment: Pittsburgh Sleep Quality Assessment
    • Time Frame: 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.

Participating in This Clinical Trial

Inclusion Criteria

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

• Refusal to undergo a spinal cord stimulator procedure

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Prisma Health-Upstate
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Joshua Smith, MD, Principal Investigator, Prisma Health-Upstate

References

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.