Clinical trial NCT01550562: Effects of Programming Parameters on Back Pain Relief in Subthreshold Spinal Cord Stimulation
Official title: Precision™ High-Rate Sub-perception Spinal Cord Stimulation for the Treatment of Chronic Intractable Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2012-03-12
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Pain Relief
timeFrame: 4,8,and 12 days post temporary lead(s) implantation
Secondary outcomes:
measure: Pain Relief Responder Rate
timeFrame: 4,8,and 12 days post temporary lead(s) implantation
measure: Leg Pain Reduction
timeFrame: 4,8,and 12 days post temporary lead(s) implantation
measure: Disability
timeFrame: 4,8,and 12 days post temporary lead(s) implantation
measure: Percent Pain Relief
timeFrame: 4,8,and 12 days post temporary lead(s) implantation
measure: Quality of Life, as Measured by EQ-5D-5L
timeFrame: 4,8,and 12 days post temporary lead(s) implantation
Other outcomes:
Locations:
city: Newcastle
country: Australia
facility: Hunter Pain Clinic
state: New South Wales
Study officials:
affiliation: Boston Scientific Corporation
name: Kay Adair
role: STUDY_DIRECTOR
References: