Effects of Programming Parameters on Back Pain Relief in Subthreshold Spinal Cord Stimulation

Precision™ High-Rate Sub-perception Spinal Cord Stimulation for the Treatment of Chronic Intractable Pain

The purpose of this study is to investigate the effects of varying programming parameters in subthreshold spinal cord stimulation therapy for pain relief.

Study Overview

• Status: Terminated
• Conditions: Low Back Pain
• Intervention / Treatment: Device: Boston Scientific Precision Plus spinal cord stimulation therapy

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Newcastle, New South Wales, Australia, 2292
      • Hunter Pain Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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, Ethics Committee-approved informed consent form (ICF) provided in English

Exclusion Criteria:

• Unable to operate the PrecisionPlus™ 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 previous two exclusion criterion
• 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 investigational 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 (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 document)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Sham Stimulation; Sham subthreshold spinal cord stimulation therapy	Device: Boston Scientific Precision Plus spinal cord stimulation therapy; Epidural spinal cord stimulation (SCS) using the Boston Scientific Precision Plus SCS system
Active Comparator: Treatment 1; subthreshold spinal cord stimulation therapy	Device: Boston Scientific Precision Plus spinal cord stimulation therapy; Epidural spinal cord stimulation (SCS) using the Boston Scientific Precision Plus SCS system
Experimental: Treatment 2; subthreshold spinal cord stimulation therapy	Device: Boston Scientific Precision Plus spinal cord stimulation therapy; Epidural spinal cord stimulation (SCS) using the Boston Scientific Precision Plus SCS system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Relief	Mean within-patient difference in average back pain intensity among treatment groups	4,8,and 12 days post temporary lead(s) implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Relief Responder Rate	Difference in the proportion of subjects with ≥50% reduction in average back pain intensity among treatment groups	4,8,and 12 days post temporary lead(s) implantation
Leg Pain Reduction	Mean within-patient difference in average leg pain intensity among treatment groups	4,8,and 12 days post temporary lead(s) implantation
Disability	Mean within-patient difference in disability among treatment groups	4,8,and 12 days post temporary lead(s) implantation
Percent Pain Relief	Mean within-patient difference in overall percent pain relief among treatment groups	4,8,and 12 days post temporary lead(s) implantation
Quality of Life, as Measured by EQ-5D-5L	Mean within-patient difference in quality of life among treatment groups	4,8,and 12 days post temporary lead(s) implantation

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Study Director: Kay Adair, Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: February 15, 2012
• First Submitted That Met QC Criteria: March 7, 2012
• First Posted (Estimate): March 12, 2012

Study Record Updates

• Last Update Posted (Actual): April 29, 2021
• Last Update Submitted That Met QC Criteria: March 31, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: A7002