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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Device: Spinal Cord Stimulator

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: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative Stimulus Testing (QST)-Thermal	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

Outcome Measure	Measure Description	Time Frame
McGill Pain Questionnaire (MPQ)	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)	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)	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)	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)	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)	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)	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	Von Frey fibers are used to determine tactile sensitivity.	Change from baseline to 4 weeks
Quantitative Stimulus Testing (QST)-Pressure	An algometer is used to measure pain related to pressure.	Change from baseline to 4 weeks
Quantitative Stimulus Testing (QST)-Vibration	A tuning fork is used to measure sensitivity to vibration.	Change from baseline to 4 weeks

Collaborators and Investigators

• Sponsor: Albany Medical College
• Investigators: Principal Investigator: Julie Pilitsis, MD, PhD, AMC Department of Neurosurgery

Publications and helpful links

General Publications

• Deer T, Slavin KV, Amirdelfan K, North RB, Burton AW, Yearwood TL, Tavel E, Staats P, Falowski S, Pope J, Justiz R, Fabi AY, Taghva A, Paicius R, Houden T, Wilson D. Success Using Neuromodulation With BURST (SUNBURST) Study: Results From a Prospective, Randomized Controlled Trial Using a Novel Burst Waveform. Neuromodulation. 2018 Jan;21(1):56-66. doi: 10.1111/ner.12698. Epub 2017 Sep 29.
• Hou S, Kemp K, Grabois M. A Systematic Evaluation of Burst Spinal Cord Stimulation for Chronic Back and Limb Pain. Neuromodulation. 2016 Jun;19(4):398-405. doi: 10.1111/ner.12440. Epub 2016 May 3.
• De Ridder D, Plazier M, Kamerling N, Menovsky T, Vanneste S. Burst spinal cord stimulation for limb and back pain. World Neurosurg. 2013 Nov;80(5):642-649.e1. doi: 10.1016/j.wneu.2013.01.040. Epub 2013 Jan 12.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 29, 2017
• Primary Completion (ACTUAL): July 31, 2018
• Study Completion (ACTUAL): September 11, 2018

Study Registration Dates

• First Submitted: July 7, 2020
• First Submitted That Met QC Criteria: January 11, 2021
• First Posted (ACTUAL): January 14, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 15, 2021
• Last Update Submitted That Met QC Criteria: January 13, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID 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