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Sub-Sensory Intraspinal Neurostimulation Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01976598
Recruitment Status : Terminated (Protocol proved too cumbersome. Consequently, only one one patient enrolled, and completed.)
First Posted : November 6, 2013
Last Update Posted : January 19, 2015
Information provided by (Responsible Party):
Algos Clinical Development Thomas L. Yearwood, MD, PhD, Algos Clinical Development

Brief Summary:
To explore the optimal stimulation parameters and locations for sub-perception programming in patients with previously implanted spinal cord stimulation systems for the treatment of chronic back and/or leg pain.

Condition or disease Intervention/treatment
Back Pain Back Pain With Radiation Pain in Leg, Unspecified Other: Sub-Sensory Stimulation

Detailed Description:
Chronic pain remains a serious public health problem, resulting in approximately 100 million chronic pain patients in the U.S. alone [1]. While numerous treatments exist, none completely addresses this issue. In particular, spinal cord stimulation (SCS) has become an established technique for treating patients with chronic neuropathic pain [2]. The conventional paradigm for SCS treatment is to attempt to mask the pain by substituting the pain sensation with paresthesias [3]; however, newer studies have shown that it is possible to gain excellent pain relief without concomitant paresthesias ("sub-threshold stimulation") using different stimulation parameters [4] [5]. Because these paresthesia-free programming paradigms are still new, the best to place the stimulation and the best programming parameters to use is still unclear, making it difficult to place the leads during surgical implantation and to program the patient afterwards. Additionally, sub-threshold stimulation does not provide immediate pain relief, but may take several hours or even days to feel relief, making a simple programming session of a few hours insufficient to determine the optimal stimulation placement. While these differences from conventional SCS make programming more difficult initially, studying this new stimulation paradigm, especially differences in optimal stimulation location and the time course of pain relief, may also provide insight into the mechanism of action of sub-threshold stimulation. This protocol aims to study the optimal stimulation parameters and locations with SCS using sub-threshold stimulation.

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Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sub-Sensory Intraspinal Neurostimulation Therapy In the Treatment of Neuropathic Back and/or Leg Pain
Study Start Date : October 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Group/Cohort Intervention/treatment
Spinal Cord Stimulation: Sub-Sensory
Patients implanted with a Boston Scientific Spinal Cord Stimulation System for the treatment of chronic back and/or leg pain using Sub-Sensory Stimulation.
Other: Sub-Sensory Stimulation
Sub-Sensory Stimulation using Boston Scientific Spinal Cord Stimulation System in patients currently implanted with the system .
Other Name: Sub-Sensory Spinal Cord Stimulatiocn.

Primary Outcome Measures :
  1. Visual Analog Score (VAS) [ Time Frame: 32 days ]
    The primary outcome measure is the final visual analog score (VAS) score obtained using a paper pain diary obtained on the last evening of each program.

Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients implanted with a Boston Scientific Spinal Cord Stimulation System for the treatment of chronic back and/or leg pain

Inclusion Criteria:

  • Primary pain complaint of persistent or recurrent low back and/or leg pain, with or without leg pain, for at least 180 days prior to Baseline.
  • Received a Boston Scientific SCS System with active contacts located between superior endplate of T7 and the inferior endplate of T10 with a minimum of three active contacts within this anatomical area.
  • No back surgery within 180 days prior to Baseline.
  • Has had stimulator "on" (activated or operational) for at least 36 hours prior to Baseline evaluation.
  • Average low back and/or leg pain intensity, during the position/activity which routinely causes worst pain, of 5 or greater on a 0-10 numerical rating scale without neurostimulation.
  • If taking prescription opioids for primary chronic pain complaint (low back and/or leg pain), must have been on a stable prescription (same drug(s) and dose(s)) for 30 days prior to Baseline
  • Consumed an average total daily morphine equivalent of ≤300 mg during the 30 days prior to Baseline
  • Willing and able to comply with all protocol-required procedures and assessments/evaluations (e.g. willing to comply with opioid prescription lock throughout the study, changes to the stimulation parameters, complete twice-daily diary)
  • 22 years of age or older when written informed consent is obtained
  • Able to independently read and complete all questionnaires and assessments provided in English
  • Subject signed a valid, IRB-approved informed consent form (ICF) provided in English

Exclusion Criteria:

  • Any pain-related diagnosis or medical/psychological condition that, in the clinician's best judgment, might confound reporting of study outcomes (e.g. pelvic pain, chronic migraine, schizophrenia)
  • Current uncontrolled diabetes mellitus
  • Significant cognitive impairment at Baseline that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to assess pain intensity and/or complete a pain diary
  • Participated in any investigational study within 30 days prior to the Screening Visit or is currently participating in another clinical trial that may influence the data that will be collected for this study
  • A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception
  • Plan to receive any massage or manipulation directly over the leads or by the location of the IPG or treatments that involve sudden jerking motions of the torso at any time during the course of the study
  • Unresolved active litigation related to the pain condition being treated in the study
  • Currently involved in a worker's compensation claim
  • Unable to operate the SCS System

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01976598

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United States, Mississippi
Comprehensive Pain and Rehabilitation
Pascagoula, Mississippi, United States, 39581
Sponsors and Collaborators
Algos Clinical Development Thomas L. Yearwood, MD, PhD
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Principal Investigator: Thomas L Yearwood, MD, PhD Algos Cinical Development
Additional Information:
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Responsible Party: Algos Clinical Development Thomas L. Yearwood, MD, PhD, Medical Director / Principal Investigator, Algos Clinical Development Identifier: NCT01976598    
Other Study ID Numbers: ALG-ANA1001
20131546 ( Other Identifier: Western Institutional Review Board (WIRB®) )
First Posted: November 6, 2013    Key Record Dates
Last Update Posted: January 19, 2015
Last Verified: January 2015
Keywords provided by Algos Clinical Development Thomas L. Yearwood, MD, PhD, Algos Clinical Development:
Additional relevant MeSH terms:
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Back Pain
Neurologic Manifestations
Signs and Symptoms