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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01550562
• Other study ID #: A7002
• Status: Terminated
• Phase: N/A
• Start date: February 2012
• Est. completion date: April 2013

Study information

• Verified date: March 2021
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Device:
• Boston Scientific Precision Plus spinal cord stimulation therapy
Epidural spinal cord stimulation (SCS) using the Boston Scientific Precision Plus SCS system

Locations

Country	Name	City	State
Australia	Hunter Pain Clinic	Newcastle	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Disability	Mean within-patient difference in disability among treatment groups	4,8,and 12 days post temporary lead(s) implantation
Secondary	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
Secondary	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