Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-25 @ 1:37 PM
Study NCT ID:
NCT04708392
Status:
COMPLETED
Last Update Posted:
2021-01-15
First Post:
2020-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stimulation Change Effects on Quantitative Sensory Testing in Neuromodulation Patients
Sponsor:
Albany Medical College
Organization:
Study Overview
Official Title:
Stimulation Change Effects on Quantitative Sensory Testing in Neuromodulation Patients
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: