SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation) Study

Low Back Pain Clinical Trial

— SENSE  

Official title:

SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation)Study for the Treatment of Chronic Low Back and Leg Pain

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01990287
• Other study ID #: C-11-12
• 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
• 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)

Related Conditions & MeSH terms

• Back Pain
• Failed Back Surgery Syndrome
• Low Back Pain
• Post-Laminectomy Syndrome
• Postoperative Complications
• Spinal Diseases
• Syndrome

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