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Effects of Programming Parameters on Back Pain Relief in Subthreshold Spinal Cord Stimulation

This study has been terminated.
(In >9 months only 1 patient enrolled. Study stopped because design was too cumbersome and subjects not willing to participate)
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01550562
First received: February 15, 2012
Last updated: May 8, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to investigate the effects of varying programming parameters in subthreshold spinal cord stimulation therapy for pain relief.


Condition Intervention
Low Back Pain
Device: Boston Scientific Precision Plus spinal cord stimulation therapy

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™ High-Rate Sub-perception Spinal Cord Stimulation for the Treatment of Chronic Intractable Pain

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Pain relief [ Time Frame: 4,8,and 12 days post temporary lead(s) implantation ] [ Designated as safety issue: No ]
    Mean within-patient difference in average back pain intensity among treatment groups


Secondary Outcome Measures:
  • Pain relief responder rate [ Time Frame: 4,8,and 12 days post temporary lead(s) implantation ] [ Designated as safety issue: No ]
    Difference in the proportion of subjects with ≥50% reduction in average back pain intensity among treatment groups

  • Leg pain reduction [ Time Frame: 4,8,and 12 days post temporary lead(s) implantation ] [ Designated as safety issue: No ]
    Mean within-patient difference in average leg pain intensity among treatment groups

  • Disability [ Time Frame: 4,8,and 12 days post temporary lead(s) implantation ] [ Designated as safety issue: No ]
    Mean within-patient difference in disability among treatment groups

  • Percent pain relief [ Time Frame: 4,8,and 12 days post temporary lead(s) implantation ] [ Designated as safety issue: No ]
    Mean within-patient difference in overall percent pain relief among treatment groups

  • Quality of life [ Time Frame: 4,8,and 12 days post temporary lead(s) implantation ] [ Designated as safety issue: No ]
    Mean within-patient difference in quality of life among treatment groups


Enrollment: 1
Study Start Date: February 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sham Stimulation
Sham subthreshold spinal cord stimulation therapy
Device: Boston Scientific Precision Plus spinal cord stimulation therapy
Epidural spinal cord stimulation (SCS) using the Boston Scientific Precision Plus SCS system
Active Comparator: Treatment 1
subthreshold spinal cord stimulation therapy
Device: Boston Scientific Precision Plus spinal cord stimulation therapy
Epidural spinal cord stimulation (SCS) using the Boston Scientific Precision Plus SCS system
Experimental: Treatment 2
subthreshold spinal cord stimulation therapy
Device: Boston Scientific Precision Plus spinal cord stimulation therapy
Epidural spinal cord stimulation (SCS) using the Boston Scientific Precision Plus SCS system

  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, 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)
  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: NCT01550562

Locations
Australia, New South Wales
Hunter Pain Clinic
Newcastle, New South Wales, Australia, 2292
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Study Director: Kay Adair Boston Scientific Corporation
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01550562     History of Changes
Other Study ID Numbers: A7002
Study First Received: February 15, 2012
Last Updated: May 8, 2013
Health Authority: Australia: Human Research Ethics Committee

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

ClinicalTrials.gov processed this record on November 20, 2014