Stimulation Change Effects on Quantitative Sensory Testing in Neuromodulation Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Pain
- Sponsor
- Albany Medical College
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Quantitative Stimulus Testing (QST)-Thermal
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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 Outcomes
- Numerical Rating Scale (NRS)(Change from baseline to 4 weeks)
- Pain Catastrophizing Scale (PCS)(Change from baseline to 4 weeks)
- Epworth Sleepiness Scale (ESS)(Change from baseline to 4 weeks)
- Quantitative Stimulus Testing (QST)-Sensitivity(Change from baseline to 4 weeks)
- Quantitative Stimulus Testing (QST)-Pressure(Change from baseline to 4 weeks)
- McGill Pain Questionnaire (MPQ)(Change from baseline to 4 weeks)
- Oswestry Disability Index (ODI)(Change from baseline to 4 weeks)
- Beck's Depression Inventory (BDI)(Change from baseline to 4 weeks)
- Insomnia Severity Index (ISI)(Change from baseline to 4 weeks)
- Quantitative Stimulus Testing (QST)-Vibration(Change from baseline to 4 weeks)