Spinal Cord Stimulation (SCS) Therapy Study | NCT02371122

Studies
Spinal Cord Stimulation (SCS) Therapy Study

NCT02371122

Sponsor

MedtronicNeuro

Status

Withdrawn

Last Update Posted

Jul 10, 2015Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Failed Back Surgery Syndrome
Degenerative Disk Disease
Epidural Fibrosis
Arachnoiditis
Radiculopathies

Interventions

Therapy Setting 1 (Medtronic)
Therapy Setting 2 (Medtronic)
Therapy Setting 3 (Medtronic)
Therapy Setting 4 (Medtronic)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Nov 2016Estimated

Completion Date

Jan 2017Estimated

First Submitted Date

Feb 19, 2015

First Submission Date that Met QC Criteria

Feb 24, 2015

First Posted Date

Feb 25, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2015

Last Update Posted Date

Jul 10, 2015Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RestoreSensor or RestoreUltra Setting 1	Active Comparator	Therapy Setting 1	Device: Therapy Setting 1 (Medtronic)
RestoreSensor or RestoreUltra Setting 2	Active Comparator	Therapy Setting 2	Device: Therapy Setting 2 (Medtronic)
RestoreSensor or RestoreUltra Setting 3	Active Comparator	Therapy Setting 3	Device: Therapy Setting 3 (Medtronic)
RestoreSensor or RestoreUltra Setting 4	Sham Comparator	Therapy Setting 4	Device: Therapy Setting 4 (Medtronic)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Therapy Setting 1 (Medtronic)	Device	RestoreSensor or RestoreUltra Setting 1	RestoreSensor or RestoreUltra Setting 1

Measure	Description	Time Frame
Numeric Pain Rating Scale - Leg pain		12 weeks

Measure	Description	Time Frame
Brief Pain Inventory - Pain severity		12 weeks
Brief Pain Inventory - Pain interference		12 weeks
Quantitative Sensory Testing - Vibration threshold

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D055111	Failed Back Surgery Syndrome
D001100	Arachnoiditis
D011843	Radiculopathy

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D001416	Back Pain