High Rate Spinal Cord Stimulation (SCS) for Chronic Pain

Boston Scientific

Status: Completed

Conditions: Chronic Pain

Treatments: Device: Low Rate Stimulation; Device: High Rate Stimulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01624740

A7001

Details and patient eligibility

About

To determine the effects of varying spinal cord stimulation programming parameters, including stimulation rate, on pain intensity.

Full description

This study compared the effects of high-rate subperception stimulation with the effects of low-rate subperception stimulation on pain intensity.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic intractable pain of the trunk and/or limbs
• Documented history of trunk and/or limb pain of at least 180 days
• Average back pain intensity of 5 or greater on a 0-10 numerical rating scale during the 7-day period prior to the Screening Visit
• Pass study site's routine psychological/psychiatric evaluation within 180 days of the Trial Lead Insertion Visit
• If taking any medications for chronic pain, must be on a stable prescription during the 14-day period prior to the Trial Lead Insertion Visit and agree to continue on the same prescription throughout study participation
• Subject is willing and able to comply with all protocol-required procedures and assessments/evaluations
• Subject is able to independently read and complete all questionnaires and/or assessments provided in English
• 18 years of age or older when written informed consent is obtained
• Subject signs a valid, Institutional Review Board (IRB)-approved informed consent form (ICF) provided in English

Exclusion criteria

• Unable to operate the Precision Plus system
• Primary source of pain is cancer-related, pelvic, visceral, angina, or migraine
• Is a high surgical risk
• Is diabetic
• Is immunocompromised
• Currently on any anticoagulant medications that cannot be discontinued during perioperative period
• Untreated major depression or untreated generalized anxiety disorder
• Diagnosed with somatoform disorder, severe personality disorder, borderline personality disorder
• Diagnosed with any major psychiatric disorder not specifically listed in CE7 or CE8
• Currently diagnosed with cognitive impairment that would limit subject's ability to discern differences in pain severity, complete a pain diary, perform wound care
• Current abuse of alcohol or illicit drugs
• Subject requires Magnetic Resonance Imaging (MRI) while implanted with lead(s).
• Subject is participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study
• Subject has previously undergone a spinal cord stimulation trial or is already implanted with an active implantable device(s) to treat their pain (Implantable Pulse Generators (IPGs), implantable drug pump, etc.) or pacemaker or implantable cardiac defibrillator
• Patient is a woman who is not using adequate contraception, is pregnant or breastfeeding or intends to become pregnant during the course of the study (a urine pregnancy test must be performed within 28 days prior to the Trial Lead Insertion Visit in women of child-bearing potential and the test result documented)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Low Rate Followed By High Rate

Experimental group

Description:

The Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects received low rate stimulation (2 Hz) for 3-4 days, followed by high rate stimulation (1200 Hz) for 3-4 days.

Treatment:

Device: High Rate Stimulation

Device: Low Rate Stimulation

High Rate Followed By Low Rate

Experimental group

Description:

The Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects received high rate stimulation (1200 Hz) for 3-4 days, followed by low rate stimulation (2 Hz) for 3-4 days.

Treatment:

Device: High Rate Stimulation

Device: Low Rate Stimulation