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Stimulation Change Effects on Quantitative Sensory Testing in Neuromodulation Patients

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ClinicalTrials.gov Identifier: NCT04708392
Recruitment Status : Completed
First Posted : January 14, 2021
Last Update Posted : January 15, 2021
Sponsor:
Information provided by (Responsible Party):
Albany Medical College

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Pain Device: Spinal Cord Stimulator Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Stimulation Change Effects on Quantitative Sensory Testing in Neuromodulation Patients
Actual Study Start Date : July 29, 2017
Actual Primary Completion Date : July 31, 2018
Actual Study Completion Date : September 11, 2018
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04708392


Locations
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United States, New York
Albany Medical Center
Albany, New York, United States, 12208
Sponsors and Collaborators
Albany Medical College
Investigators
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Principal Investigator: Julie Pilitsis, MD, PhD AMC Department of Neurosurgery
More Information
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Publications:

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Responsible Party: Albany Medical College
ClinicalTrials.gov Identifier: NCT04708392    
Other Study ID Numbers: Burst 682552
First Posted: January 14, 2021    Key Record Dates
Last Update Posted: January 15, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

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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
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations