High Rate Spinal Cord Stimulation (SCS) for Chronic Pain

March 9, 2015 updated by: Boston Scientific Corporation

Precision Plus™ High-Rate Subperception SCS for the Treatment of Chronic Intractable Pain

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study compared the effects of high-rate subperception stimulation with the effects of low-rate subperception stimulation on pain intensity.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Carlsbad, California, United States, 92009
        • Coastal Pain Spinal Diagnostic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 28 days prior to the Trial Lead Insertion Visit in women of child-bearing potential and the test result documented)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Low Rate Followed By High Rate
The Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects received low rate stimulation (2 Hz) for 3-4 days, followed by high rate stimulation (1200 Hz) for 3-4 days.
Device: Low Rate Stimulation
Stimulation was given at a rate of 2 Hz.
Device: High Rate Stimulation
Stimulation was given at a rate of 1200 Hz.
EXPERIMENTAL: High Rate Followed By Low Rate
The Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects received high rate stimulation (1200 Hz) for 3-4 days, followed by low rate stimulation (2 Hz) for 3-4 days.
Device: Low Rate Stimulation
Stimulation was given at a rate of 2 Hz.
Device: High Rate Stimulation
Stimulation was given at a rate of 1200 Hz.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Back Pain Intensity
Time Frame: For this measure, outcome was assessed at baseline, the end of the first intervention (3 or 4 days post-implantation, depending on the subject), and the end of the second intervention (6 or 8 days post-implantation, depending on the subject).
Back pain intensity was measured on a 0-10 numerical rating scale (0="no pain", 10="worst pain imaginable") at baseline and following low rate and high rate stimulation. This outcome measure compared the change in intensity from baseline between low rate and high rate stimulation.
For this measure, outcome was assessed at baseline, the end of the first intervention (3 or 4 days post-implantation, depending on the subject), and the end of the second intervention (6 or 8 days post-implantation, depending on the subject).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Study Director: Omid Khodai, OD, Boston Scientific Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (ACTUAL)

September 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

June 15, 2012

First Submitted That Met QC Criteria

June 19, 2012

First Posted (ESTIMATE)

June 21, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 20, 2015

Last Update Submitted That Met QC Criteria

March 9, 2015

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A7001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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