Skip to main content
OpenTrials
Completed

NCT Number: NCT04708392

Stimulation Change Effects on Quantitative Sensory Testing in Neuromodulation Patients

This study is designed to evaluate the effectiveness of two types of spinal cord stimulation programming types, in comparison to each other as well as patient baseline data.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Albany Medical Center

Albany, New York, 12208, United States

About this study

In this study patients have been implanted with an Abbott spinal cord stimulator capable of delivering both tonic (continuous) stimulation as well as Burst (intermittent) stimulation. Patients are programmed to be in both stimulation modes for a study period of 4 weeks, after which their pain symptoms are evaluated on a variety of surveys: McGill Pain Questionnaire (MPQ), Oswestry Disability Index (ODI), Beck Depression Inventory (BDI), Pain Catastrophizing Scale (PCS), Epworth Sleepiness Scale (ESS), Insomnia Severity Index (ISI), Numerical Rating Scale (NRS) and Global Improvement. They also undergo Quantitative Sensory Testing (QST), where thermal, mechanical, vibration and pressure stimuli are applied to the patient and detection limits are documented.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Albany Medical Center neurosurgery patients with chronic leg and/or back pain, that have, or are going to have, spinal cord stimulator implantation.
  • Patients are >/= 18 years old at the time of enrollment.
  • Patients must be: fluent in English; mentally competent; able to read and answer questionnaires; complete pain assessments; and give informed consent.

Exclusion criteria

  • Patients less than 18 years old.
  • Patients unable or unwilling to: read and answer questionnaires; complete pain assessments; and give informed consent.

Treatment and study plan

Spinal cord stimulator

Device

A spinal cord stimulator is a surgically implanted device that delivers an electrical signal to a patient's spinal cord to reduce the perception of pain

Primary outcomes

  1. Quantitative Stimulus Testing (QST)-Thermal

    Time frame: Change from baseline to 4 weeks

    Thermal stimulus testing - thermal stimulation system is used to record hot and cold sensation and pain thresholds.

Secondary outcomes

  1. McGill Pain Questionnaire (MPQ)

    Time frame: Change from baseline to 4 weeks

    This outcome measurement tool contains 15 descriptive words (11 sensory and 4 affective) used by subjects to describe their pain. Total number of words chosen is documented

  2. Oswestry Disability Index (ODI)

    Time frame: Change from baseline to 4 weeks

    This measurement tool assesses functional outcome for 10 conditions in subjects with chronic pain. Patients select a statement for each condition that most closely resembles their own situation. Each statement has a score of 0-5, depending on the severity of the particular disability. Raw scores are calculated into a disability percentage.

  3. Beck's Depression Inventory (BDI)

    Time frame: Change from baseline to 4 weeks

    This is a 21 section multiple-choice self-report survey. Patients select a statement in each section that most closely resembles their own situation. Each statement has a score of 0-3, depending on the severity of the depressive content. Raw scores are tallied.

  4. Pain Catastrophizing Scale (PCS)

    Time frame: Change from baseline to 4 weeks

    This is a 13 question survey. It is used to assess the degree to which patients ruminate on, magnify, and/or amplify their pain symptoms. Patients rate on a scale of 0-4 (never - all the time) how often they have each of the thoughts listed. Raw scores are tallied

  5. Numerical Rating Scale (NRS)

    Time frame: Change from baseline to 4 weeks

    Patients rate, on a scale of 0-10, their pain at it's least, most, and average over the past week. They also rate their pain "right now" as well as their perception of Global Improvement.

  6. Epworth Sleepiness Scale (ESS)

    Time frame: Change from baseline to 4 weeks

    This survey is used to assess the 'daytime sleepiness' of patients. Patients rate the likelihood of falling asleep during several daytime scenarios, on a scale of 0-3 (never - very likely). Raw scores are tallied.

  7. Insomnia Severity Index (ISI)

    Time frame: Change from baseline to 4 weeks

    This survey is designed to assess the nature, severity, and impact of insomnia in adults. Patients are asked to rate on a scale of 0-4 (no problem - very much a problem) how much of a problem they have with several sleep conditions. Raw scores are tallied.

  8. Quantitative Stimulus Testing (QST)-Sensitivity

    Time frame: Change from baseline to 4 weeks

    Von Frey fibers are used to determine tactile sensitivity.

  9. Quantitative Stimulus Testing (QST)-Pressure

    Time frame: Change from baseline to 4 weeks

    An algometer is used to measure pain related to pressure.

  10. Quantitative Stimulus Testing (QST)-Vibration

    Time frame: Change from baseline to 4 weeks

    A tuning fork is used to measure sensitivity to vibration.

Sponsors and collaborators

Lead sponsor

Albany Medical College

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 14, 2021
Registry last updated
Jan 15, 2021

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.