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NCT Number: NCT03764514

Spinal Cord Stimulation in Chemotherapy Induced Neuropathy

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.

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Key information

Conditions

Chemotherapy-induced Peripheral Neuropathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Patewood Memorial Hospital

Greenville, South Carolina, 29615, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Refusal to undergo a spinal cord stimulator procedure

Treatment and study plan

Spinal cord stimulator

Device

Permanent Implantation

Primary outcomes

  1. 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

  1. 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.

  2. 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.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Prisma Health-Upstate

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Dec 5, 2018
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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