Stimulation Change Effects on Quantitative Sensory Testing in Neuromodulation Patients

January 13, 2021 updated by: Albany Medical College
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Tonic spinal cord stimulation
Patients are programmed with tonic (continuous) spinal cord stimulation for a period of four weeks.
Device: Spinal Cord Stimulator
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
EXPERIMENTAL: Burst spinal cord stimulation
Patients are programmed with burst (intermittent) spinal cord stimulation for a period of four weeks.
Device: Spinal Cord Stimulator
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Change from baseline to 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Change from baseline to 4 weeks
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.
Change from baseline to 4 weeks
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.
Change from baseline to 4 weeks
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
Change from baseline to 4 weeks
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.
Change from baseline to 4 weeks
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.
Change from baseline to 4 weeks
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.
Change from baseline to 4 weeks
Quantitative Stimulus Testing (QST)-Sensitivity
Time Frame: Change from baseline to 4 weeks
Von Frey fibers are used to determine tactile sensitivity.
Change from baseline to 4 weeks
Quantitative Stimulus Testing (QST)-Pressure
Time Frame: Change from baseline to 4 weeks
An algometer is used to measure pain related to pressure.
Change from baseline to 4 weeks
Quantitative Stimulus Testing (QST)-Vibration
Time Frame: Change from baseline to 4 weeks
A tuning fork is used to measure sensitivity to vibration.
Change from baseline to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Albany Medical College

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Julie Pilitsis, MD, PhD, AMC Department of Neurosurgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 29, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 11, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 7, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 15, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Burst 682552

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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