Stimulation Change Effects on Quantitative Sensory Testing in Neuromodulation Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Stimulation Change Effects on Quantitative Sensory Testing in Neuromodulation Patients

Conditions
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Chronic Pain

Intervention / Treatment
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* Device: Spinal Cord Stimulator


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tonic spinal cord stimulation<br>Patients are programmed with tonic (continuous) spinal cord stimulation for a period of four weeks. | Device: Spinal Cord Stimulator<br>* 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<br>|
| Experimental: Burst spinal cord stimulation<br>Patients are programmed with burst (intermittent) spinal cord stimulation for a period of four weeks. | Device: Spinal Cord Stimulator<br>* 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<br>|

What is the study measuring?
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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 |