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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01990287
Other study ID # C-11-12
Secondary ID
Status Terminated
Phase N/A
First received November 15, 2013
Last updated April 11, 2016
Start date November 2013
Est. completion date February 2016

Study information

Verified date April 2016
Source St. Jude Medical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to demonstrate safety and efficacy of spinal cord stimulation with peripheral nerve field stimulation for the treatment of chronic low back and leg pain.


Recruitment information / eligibility

Status Terminated
Enrollment 38
Est. completion date February 2016
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender All
Age group 22 Years and older
Eligibility Key Inclusion Criteria:

- Subject is 22 years of age or older

- Subject has chronic low back and leg pain secondary to Failed Back Surgery Syndrome (FBSS)

- Subject has an average score of 6 or higher for average daily overall pain on the Numerical Rating Scale (NRS) based on the 7 day pain diary

- Subject has attempted "best" medical therapy and has tried and failed at least three documented medically supervised treatments (including, but not limited to physical therapy, acupuncture, etc.) and has failed medication treatment from at least two different classes

- Subject's pain-related medication regimen is stable 4 weeks prior to the baseline evaluation

- Subject agrees not to add or increase pain-related medication throughout the 12 week randomized evaluation phase of the study (starting at activation)

Key Exclusion Criteria:

- Subject currently participating in a clinical investigation that includes an active treatment arm

- Subject has been implanted with a previous neuromodulation system (PNfS, SCS-PNfS or SCS) or participated in a trial for a neuromodulation system

- Subject's overall Beck Depression Inventory II Score is > 24 or has a score of 3 on question 9 relating to suicidal thoughts or wishes at the baseline visit

- Subject with an infusion pump or any implantable neurostimulator device

- Subject has an existing medical condition that is likely to require repetitive MRI evaluation in the future (i.e. epilepsy, stroke, multiple sclerosis, acoustic neuroma, tumor)

- Subject has an existing medical condition that is likely to require the use of diathermy in the future

- Subject has peripheral vascular disease

- Subject is immunocompromised

- Subject has documented history of allergic response to titanium or silicone

- Subject has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the 6 months prior to baseline data collection

- Female candidates of child bearing potential that are pregnant (confirmed by positive pregnancy test)

Study Design


Intervention

Device:
SCS and PNfS
Spinal Cord Stimulation (SCS) in combination with Peripheral Nerve Field Stimulation (PNfS). The SCS leads will be placed in the Thoracolumbar region and the PNfS lead will be placed subcutaneously in the area of pain.
SCS Alone
Spinal Cord Stimulation (SCS) only. The SCS leads will be placed in the Thoracolumbar region only.

Locations

Country Name City State
United States Michigan Pain Specialists Brighton Michigan
United States Montefiore Medical Center Bronx New York
United States Comprehensive Pain Specialists Broomfield Colorado
United States Comprehensive Pain Management Center Campbell California
United States Coastal Pain & Spinal Diagnostics Medical Group Carlsbad California
United States The Center for Pain Relief Charleston West Virginia
United States Integrated Pain Solutions Columbus Ohio
United States Pain and Spine Center Dayton Ohio
United States Duke University Medical Center Durham North Carolina
United States Mid Atlantic Spine and Pain Physicians Elkton Maryland
United States Holy Cross Orthopedics Fort Lauderdale Florida
United States Vertex Spine and Pain Franklin Tennessee
United States Neurological Surgery, P.C. Lake Success New York
United States The Mocek Spine Clinic Little Rock Arkansas
United States Bluegrass Pain Louisville Kentucky
United States Interventional Pain Care Muncie Indiana
United States Pacific Pain Medicine Consultants Oceanside California
United States Pasadena Rehabilitation Institute Pasadena California
United States Comprehensive Pain & Rehabilitation Pascagoula Mississippi
United States The Pain Center of Arizona Phoenix Arizona
United States Performance Spine and Sports Physicians, P.C. Pottstown Pennsylvania
United States Arizona Pain Specialists Scottsdale Arizona
United States Valley Pain Consultants - N. Scottsdale Scottsdale Arizona
United States Pain Care LLC Stockbridge Georgia
United States H. Lee Moffitt Cancer and Research Institute Tampa Florida
United States Granger Pain and Spine West Jordan Utah
United States Bright Health Physicians of PIH Whittier California
United States Carolina Pain Institute Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
St. Jude Medical

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety Evaluation of device or procedure related adverse events 6 months
Primary Efficacy Responder rate in SCS-PNfS vs SCS alone 3 months
Secondary Quality of Life 3 months
Secondary Functional Disability 3 months
Secondary Worst pain 3 months
Secondary Rescue medication usage 3 months
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