High Rate Spinal Cord Stimulation (SCS) for Chronic Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Boston Scientific Corporation
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01624740
First received: June 15, 2012
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention
Chronic Pain
Device: Precision Plus Spinal Cord Stimulation system

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 between treatment and control [ Time Frame: At the end of period 1 (3-4 days post lead implantation) and at the end of period 2 (6-8 days post lead implantation) ] [ Designated as safety issue: No ]
    Back pain intensity on a 0-10 numerical rating scale (0="no pain", 10="worst pain imaginable")


Secondary Outcome Measures:
  • Change in responser status based on ≥50% reduction in average back pain intensity between treatment and control [ Time Frame: At end of Period 1 (3-4 days post lead implantation) and at end of period 2 (6-8 days post lead implantation) ] [ Designated as safety issue: No ]
  • Change in average leg pain intensity between treatment and control [ Time Frame: At end of Period 1 (3-4 days post lead implantation) and at end of Period 2 (6-8 days post lead implantation) ] [ Designated as safety issue: No ]
  • Change in disability between treatment and control [ Time Frame: At end of Period 1 (3-4 days post lead implantation) and at end of Period 2 (6-8 days post lead implantation) ] [ Designated as safety issue: No ]
  • Change in overall percent pain relief between treatment and control [ Time Frame: At end of Period 1 (3-4 days post lead implantation) and at end of Period 2 (6-8 days post lead implantation) ] [ Designated as safety issue: No ]
  • Change in quality of life between treatment and control [ Time Frame: At end of Period 1 (3-4 days post lead implantation) and at end of Period 2 (6-8 days post lead implantation) ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: June 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Low Rate subperception Precision SCS trial therapy Device: Precision Plus Spinal Cord Stimulation system
The Precision Plus spinal cord stimulation screening trial lead(s) will be temporarily implanted by the investigator
Experimental: High rate subperception Precision SCS trial therapy Device: Precision Plus Spinal Cord Stimulation system
The Precision Plus spinal cord stimulation screening trial lead(s) will be temporarily implanted by the investigator

  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

Contacts
Contact: Diane Bowers (661) 949-4175 Diane.Bowers@bsci.com

Locations
United States, California
Coastal Pain Spinal Diagnostic Recruiting
Carlsbad, California, United States, 92009
Contact: Trisha Mejia    760-753-7127      
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Study Director: Tamara Baynham, PhD 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
Last Updated: November 12, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 09, 2014