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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01550562

Enrollment

Registered

2012-03-12

Start date

2012-02-29

Completion date

2013-04-30

Last updated

2021-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

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.

Interventions

DEVICEBoston Scientific Precision Plus spinal cord stimulation therapy

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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
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

Countries

Australia

Participant flow

Pre-assignment details

1 subject was enrolled in this study.

Participants by arm

Arm	Count
Randomized Eligible patients who were randomized in a 1:1:1:1:1:1 ratio to one of the six sequences of three treatment groups (sham stimulation, subthreshold spinal cord stimulation therapy 1, and subthreshold spinal cord stimulation therapy 2).	1
Total	1

Baseline characteristics

Characteristic	Randomized
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	1 Participants
Age, Categorical Between 18 and 65 years	0 Participants
Region of Enrollment Australia	1 participants
Sex: Female, Male Female	1 Participants
Sex: Female, Male Male	0 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 1
other Total, other adverse events	0 / 1
serious Total, serious adverse events	0 / 1