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Spinal Cord Stimulation (SCS) Therapy Study

Primary Purpose

Failed Back Surgery Syndrome, Degenerative Disk Disease, Epidural Fibrosis

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Therapy Setting 1 (Medtronic)
Therapy Setting 2 (Medtronic)
Therapy Setting 3 (Medtronic)
Therapy Setting 4 (Medtronic)
Sponsored by
MedtronicNeuro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Failed Back Surgery Syndrome

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • At least 22 years of age or older at the time of informed consent
  • Implanted with a Medtronic RestoreSensor or RestoreUltra SCS system for an on-label indication at least 6 months for the treatment of chronic leg pain, with or without back pain
  • Implanted with one or more Medtronic leads located in the epidural space within the thoracic area
  • Receiving some level of pain relief with current SCS therapy
  • On a stable dose (no new, discontinued or changes in) of all prescription pain medications and willing to maintain or only decrease the dose of all prescribed pain medications
  • Read and understand English without assistance
  • Willing and able to comply with all study procedures, study visits, and be available for the duration of the study

Exclusion Criteria:

  • Diagnosed with complex regional pain syndrome (CRPS), peripheral causalgia, or reflex sympathetic dystrophy (RSD), or causalgia
  • Has leg, knee, or foot pain unrelated to on-label indication for SCS therapy (for eg, arthritis, knee surgery, etc.)
  • Implanted with both a surgical and percutaneous lead
  • Implanted with a peripheral lead for subcutaneous or peripheral nerve stimulation

  • Has had any of the following procedures:

    • Neuroablative procedure within six months
    • Neurolytic block within two months
    • Injection therapy for pain within four weeks
    • Sympathetic block within two weeks
  • Has an active implanted device (besides RestoreUltra or RestoreSensor neurostimulator), whether turned ON or OFF
  • Pregnant or lactating, inadequate birth control, or at risk of pregnancy during this study
  • Has an untreated psychiatric comorbidity
  • Has serious drug-related behavioral issues
  • Has active malignancy or has been diagnosed with cancer and has not been in remission for at least one year
  • Has secondary gains which, in the opinion of the investigator, are likely to interfere with the study
  • Participating or planning to participate in another clinical trial while enrolled in this study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Sham Comparator

    Arm Label

    RestoreSensor or RestoreUltra Setting 1

    RestoreSensor or RestoreUltra Setting 2

    RestoreSensor or RestoreUltra Setting 3

    RestoreSensor or RestoreUltra Setting 4

    Arm Description

    Therapy Setting 1

    Therapy Setting 2

    Therapy Setting 3

    Therapy Setting 4

    Outcomes

    Primary Outcome Measures

    Numeric Pain Rating Scale - Leg pain

    Secondary Outcome Measures

    Brief Pain Inventory - Pain severity
    Brief Pain Inventory - Pain interference
    Quantitative Sensory Testing - Vibration threshold
    Quantitative Sensory Testing - Electrical stimuli tolerance
    Numeric Pain Rating Scale - Back pain

    Full Information

    First Posted
    February 19, 2015
    Last Updated
    July 9, 2015
    Sponsor
    MedtronicNeuro
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02371122
    Brief Title
    Spinal Cord Stimulation (SCS) Therapy Study
    Official Title
    Spinal Cord Stimulation (SCS) Therapy Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    June 2015 (undefined)
    Primary Completion Date
    November 2016 (Anticipated)
    Study Completion Date
    January 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    MedtronicNeuro

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the effect of different spinal cord stimulation settings in the treatment of leg pain. Subjects will receive a randomized order of four different programmed stimulation settings for 3 weeks each followed by a fifth and final setting.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Failed Back Surgery Syndrome, Degenerative Disk Disease, Epidural Fibrosis, Arachnoiditis, Radiculopathies

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    RestoreSensor or RestoreUltra Setting 1
    Arm Type
    Active Comparator
    Arm Description
    Therapy Setting 1
    Arm Title
    RestoreSensor or RestoreUltra Setting 2
    Arm Type
    Active Comparator
    Arm Description
    Therapy Setting 2
    Arm Title
    RestoreSensor or RestoreUltra Setting 3
    Arm Type
    Active Comparator
    Arm Description
    Therapy Setting 3
    Arm Title
    RestoreSensor or RestoreUltra Setting 4
    Arm Type
    Sham Comparator
    Arm Description
    Therapy Setting 4
    Intervention Type
    Device
    Intervention Name(s)
    Therapy Setting 1 (Medtronic)
    Intervention Description
    RestoreSensor or RestoreUltra Setting 1
    Intervention Type
    Device
    Intervention Name(s)
    Therapy Setting 2 (Medtronic)
    Intervention Description
    Medtronic RestoreSensor or RestoreUltra Setting 2
    Intervention Type
    Device
    Intervention Name(s)
    Therapy Setting 3 (Medtronic)
    Intervention Description
    Medtronic RestoreSensor or RestoreUltra Setting 3
    Intervention Type
    Device
    Intervention Name(s)
    Therapy Setting 4 (Medtronic)
    Intervention Description
    Medtronic RestoreSensor or RestoreUltra Setting 4
    Primary Outcome Measure Information:
    Title
    Numeric Pain Rating Scale - Leg pain
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Brief Pain Inventory - Pain severity
    Time Frame
    12 weeks
    Title
    Brief Pain Inventory - Pain interference
    Time Frame
    12 weeks
    Title
    Quantitative Sensory Testing - Vibration threshold
    Time Frame
    12 weeks
    Title
    Quantitative Sensory Testing - Electrical stimuli tolerance
    Time Frame
    12 weeks
    Title
    Numeric Pain Rating Scale - Back pain
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    22 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: At least 22 years of age or older at the time of informed consent Implanted with a Medtronic RestoreSensor or RestoreUltra SCS system for an on-label indication at least 6 months for the treatment of chronic leg pain, with or without back pain Implanted with one or more Medtronic leads located in the epidural space within the thoracic area Receiving some level of pain relief with current SCS therapy On a stable dose (no new, discontinued or changes in) of all prescription pain medications and willing to maintain or only decrease the dose of all prescribed pain medications Read and understand English without assistance Willing and able to comply with all study procedures, study visits, and be available for the duration of the study Exclusion Criteria: Diagnosed with complex regional pain syndrome (CRPS), peripheral causalgia, or reflex sympathetic dystrophy (RSD), or causalgia Has leg, knee, or foot pain unrelated to on-label indication for SCS therapy (for eg, arthritis, knee surgery, etc.) Implanted with both a surgical and percutaneous lead Implanted with a peripheral lead for subcutaneous or peripheral nerve stimulation Has had any of the following procedures: Neuroablative procedure within six months Neurolytic block within two months Injection therapy for pain within four weeks Sympathetic block within two weeks Has an active implanted device (besides RestoreUltra or RestoreSensor neurostimulator), whether turned ON or OFF Pregnant or lactating, inadequate birth control, or at risk of pregnancy during this study Has an untreated psychiatric comorbidity Has serious drug-related behavioral issues Has active malignancy or has been diagnosed with cancer and has not been in remission for at least one year Has secondary gains which, in the opinion of the investigator, are likely to interfere with the study Participating or planning to participate in another clinical trial while enrolled in this study

    12. IPD Sharing Statement

    Learn more about this trial

    Spinal Cord Stimulation (SCS) Therapy Study

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