Stimulation Change Effects on Quantitative Sensory Testing in Neuromodulation Patients

Not Applicable

Completed

• Conditions: Chronic Pain
• Interventions: Device: Spinal Cord Stimulator

• Registration Number: NCT04708392
• Lead Sponsor: Albany Medical College

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.

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 Timeline

• Study Start: 2017-07-29
• Primary Completion: 2018-07-31
• Study Completion: 2018-09-11
• Study First Submitted: 2020-07-07
• Status Verified: 2021-01
• Study First Submitted QC: 2021-01-11
• Last Update Submitted: 2021-01-13
• Study First Posted: 2021-01-14
• Last Update Posted: 2021-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tonic spinal cord stimulation	Spinal Cord Stimulator	Patients are programmed with tonic (continuous) spinal cord stimulation for a period of four weeks.
Burst spinal cord stimulation	Spinal Cord Stimulator	Patients are programmed with burst (intermittent) spinal cord stimulation for a period of four weeks.

Primary Outcome Measures

Name	Time	Method
Quantitative Stimulus Testing (QST)-Thermal	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

Name	Time	Method
Numerical Rating Scale (NRS)	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.
Pain Catastrophizing Scale (PCS)	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
Epworth Sleepiness Scale (ESS)	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.
Quantitative Stimulus Testing (QST)-Sensitivity	Change from baseline to 4 weeks	Von Frey fibers are used to determine tactile sensitivity.
Quantitative Stimulus Testing (QST)-Pressure	Change from baseline to 4 weeks	An algometer is used to measure pain related to pressure.
McGill Pain Questionnaire (MPQ)	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
Oswestry Disability Index (ODI)	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.
Beck's Depression Inventory (BDI)	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.
Insomnia Severity Index (ISI)	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.
Quantitative Stimulus Testing (QST)-Vibration	Change from baseline to 4 weeks	A tuning fork is used to measure sensitivity to vibration.

Trial Locations

Locations (1)

Albany Medical Center; 🇺🇸 Albany, New York, United States