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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
16
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
Albany Medical Center
Albany, New York, United States
Quantitative Stimulus Testing (QST)-Thermal
Thermal stimulus testing - thermal stimulation system is used to record hot and cold sensation and pain thresholds.
Time frame: Change from baseline to 4 weeks
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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Change from baseline to 4 weeks
Numerical Rating Scale (NRS)
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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.
Time frame: 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.
Time frame: 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.
Time frame: Change from baseline to 4 weeks
Quantitative Stimulus Testing (QST)-Sensitivity
Von Frey fibers are used to determine tactile sensitivity.
Time frame: Change from baseline to 4 weeks
Quantitative Stimulus Testing (QST)-Pressure
An algometer is used to measure pain related to pressure.
Time frame: Change from baseline to 4 weeks
Quantitative Stimulus Testing (QST)-Vibration
A tuning fork is used to measure sensitivity to vibration.
Time frame: Change from baseline to 4 weeks