Spinal Cord Stimulation (SCS) Therapy Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Failed Back Surgery Syndrome Degenerative Disk Disease Epidural Fibrosis Arachnoiditis Radiculopathies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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RestoreSensor or RestoreUltra Setting 1

Therapy Setting 1

Group Type ACTIVE_COMPARATOR

Therapy Setting 1 (Medtronic)

Intervention Type DEVICE

RestoreSensor or RestoreUltra Setting 1

RestoreSensor or RestoreUltra Setting 2

Therapy Setting 2

Group Type ACTIVE_COMPARATOR

Therapy Setting 2 (Medtronic)

Intervention Type DEVICE

Medtronic RestoreSensor or RestoreUltra Setting 2

RestoreSensor or RestoreUltra Setting 3

Therapy Setting 3

Group Type ACTIVE_COMPARATOR

Therapy Setting 3 (Medtronic)

Intervention Type DEVICE

Medtronic RestoreSensor or RestoreUltra Setting 3

RestoreSensor or RestoreUltra Setting 4

Therapy Setting 4

Group Type SHAM_COMPARATOR

Therapy Setting 4 (Medtronic)

Intervention Type DEVICE

Medtronic RestoreSensor or RestoreUltra Setting 4

Interventions

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Therapy Setting 1 (Medtronic)

RestoreSensor or RestoreUltra Setting 1

Intervention Type DEVICE

Therapy Setting 2 (Medtronic)

Medtronic RestoreSensor or RestoreUltra Setting 2

Intervention Type DEVICE

Therapy Setting 3 (Medtronic)

Medtronic RestoreSensor or RestoreUltra Setting 3

Intervention Type DEVICE

Therapy Setting 4 (Medtronic)

Medtronic RestoreSensor or RestoreUltra Setting 4

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No