Stimulation Change Effects on Quantitative Sensory Testing in Neuromodulation Patients

Albany Medical College

Status: Completed

Conditions: Chronic Pain

Treatments: Device: Spinal Cord Stimulator

Study type: Interventional

Funder types: Other

Identifiers

NCT04708392

Burst 682552

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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16 participants in 2 patient groups

Tonic spinal cord stimulation

Experimental group

Description:

Patients are programmed with tonic (continuous) spinal cord stimulation for a period of four weeks.

Treatment:

Device: Spinal Cord Stimulator

Burst spinal cord stimulation

Experimental group

Description:

Patients are programmed with burst (intermittent) spinal cord stimulation for a period of four weeks.

Treatment:

Device: Spinal Cord Stimulator