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

Not Applicable

Terminated

• Conditions: Low Back Pain
• Interventions: Device: Boston Scientific Precision Plus spinal cord stimulation therapy

• Registration Number: NCT01550562
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-15
• Study First Submitted QC: 2012-03-07
• Study First Posted: 2012-03-12
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2021-03
• Results First Submitted: 2021-03-31
• Results First Submitted QC: 2021-03-31
• Last Update Submitted: 2021-03-31
• Results First Posted: 2021-04-29
• Last Update Posted: 2021-04-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment 1	Boston Scientific Precision Plus spinal cord stimulation therapy	subthreshold spinal cord stimulation therapy
Treatment 2	Boston Scientific Precision Plus spinal cord stimulation therapy	subthreshold spinal cord stimulation therapy
Sham Stimulation	Boston Scientific Precision Plus spinal cord stimulation therapy	Sham subthreshold spinal cord stimulation therapy

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hunter Pain Clinic; 🇦🇺 Newcastle, New South Wales, Australia