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

NCT ID: NCT01550562

Last Updated: 2021-04-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2013-04-30

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.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sham Stimulation

Sham subthreshold spinal cord stimulation therapy

Group Type: PLACEBO_COMPARATOR

Boston Scientific Precision Plus spinal cord stimulation therapy

Intervention Type: DEVICE

Epidural spinal cord stimulation (SCS) using the Boston Scientific Precision Plus SCS system

Treatment 1

subthreshold spinal cord stimulation therapy

Group Type: ACTIVE_COMPARATOR

Boston Scientific Precision Plus spinal cord stimulation therapy

Intervention Type: DEVICE

Epidural spinal cord stimulation (SCS) using the Boston Scientific Precision Plus SCS system

Treatment 2

subthreshold spinal cord stimulation therapy

Group Type: EXPERIMENTAL

Boston Scientific Precision Plus spinal cord stimulation therapy

Intervention Type: DEVICE

Epidural spinal cord stimulation (SCS) using the Boston Scientific Precision Plus SCS system

Interventions

Boston Scientific Precision Plus spinal cord stimulation therapy

Epidural spinal cord stimulation (SCS) using the Boston Scientific Precision Plus SCS system

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kay Adair

Role: STUDY_DIRECTOR

Boston Scientific Corporation

Locations

Hunter Pain Clinic

Newcastle, New South Wales, Australia

Countries

Australia

Other Identifiers

A7002

Identifier Type: -

Identifier Source: org_study_id