High Rate Spinal Cord Stimulation (SCS) for Chronic Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01624740
First received: June 15, 2012
Last updated: March 9, 2015
Last verified: December 2014
  Purpose

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


Condition Intervention
Chronic Pain
Device: Low Rate Stimulation
Device: High Rate Stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Precision Plus™ High-Rate Subperception SCS for the Treatment of Chronic Intractable Pain

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
    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.


Enrollment: 20
Study Start Date: June 2012
Study Completion Date: December 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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, 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01624740

Locations
United States, California
Coastal Pain Spinal Diagnostic
Carlsbad, California, United States, 92009
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Study Director: Omid Khodai, OD Boston Scientific Corporation
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01624740     History of Changes
Other Study ID Numbers: A7001
Study First Received: June 15, 2012
Results First Received: December 18, 2014
Last Updated: March 9, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Chronic Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2015