Skip to content

High Rate Spinal Cord Stimulation (SCS) for Chronic Pain

CompletedNot applicableNCT01624740
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

To determine the effects of varying spinal cord stimulation programming parameters, including stimulation rate, on pain intensity.

Study details

Official title
Precision Plus™ High-Rate Subperception SCS for the Treatment of Chronic Intractable Pain
Conditions
Interventions
  • Device: Low Rate Stimulation
  • Device: High Rate Stimulation
Sponsor
Boston Scientific Corporation
Start date
2012-06
Primary completion
2013-09
Sex
All
Age range
from 18 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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, Institutional Review Board (IRB)-approved informed consent form (ICF) provided in English Exclusion Criteria: * Unable to operate the Precision Plus 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 CE7 or CE8 * 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 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 (Implantable Pulse Generators (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 2…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01624740