Clinical trial NCT01818297: Subcutaneous Nerve Stimulation for Failed Back Surgery Syndrome (FBSS) Patients
Official title: SubQStim Pivotal Study: A Prospective, Randomized, Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Nerve Stimulation. Protocol 1666
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Failed Back Surgery Syndrome
Post-laminectomy Syndrome
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2013-03-26
Enrollment: 137
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of Subcutaneous Nerve Stimulation (SQS) (also known as Peripheral Nerve Stimulation \[PNS\]) in the reduction of chronic, intractable post-surgical back pain in adults.

Detailed description: This study is a multi-center, prospective, randomized (1:1) parallel-group design.

Eligibility criteria: Key Inclusion Criteria:

* Have persistent back pain for at least 6 months
* Had back surgery at least 6 months ago
* Have tried pain medications and physical therapy
* Read and understand written English or Spanish
* Male or non-pregnant female. If female of child-bearing potential, and if sexually active, must be using a medically-acceptable method of birth control during study participation
* Willing and able to undergo surgical implant procedure, attend visits as scheduled, and comply with the study requirements
* Have an expected lifespan greater than 12 months

Key Exclusion Criteria:

* Have leg pain in addition to back pain.
* Currently enrolled in or plan to enroll in another drug and/or device study
* Have peripheral vascular disease, peripheral neuropathy, small-fiber neuropathy, or fibromyalgia
* Have an active systemic infection or are immunocompromised
* Will be exposed to diathermy or anticipate needing a full-body MRI scan
* Currently have an implantable cardiac pacemaker, defibrillator, or neurostimulator
* Treated with spinal cord stimulation, peripheral nerve stimulation, an intrathecal drug delivery system or requires additional back surgery

Primary outcomes:
measure: Number of Back Pain Responders (Subjects Who Achieve at Least a 50% Reduction in Average Back Pain With no Increase in Prescription Pain Medications) From Baseline to Month 3 Post-device Activation.
timeFrame: Baseline to 3 months
Secondary outcomes:
measure: Functional Disability
timeFrame: Baseline to 3 months
measure: Subject Satisfaction
timeFrame: 3 months
measure: Quality of Life: Physical
timeFrame: Baseline to 3 months
measure: Quality of Life: Mental
timeFrame: Baseline to 3 months
measure: Worst Back Pain
timeFrame: Baseline to 3 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Valley Pain Consultants
state: Arizona
city: Phoenix
country: United States
facility: HOPE Research Institute
state: Arizona
city: Carlsbad
country: United States
facility: Coastal Pain Research
state: California
city: Fountain Valley
country: United States
facility: Pain Medicine Associates
state: California
city: Merritt Island
country: United States
facility: Florida Pain Institute
state: Florida
city: Miami
country: United States
facility: Advanced Medicine and Pain Management Research
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Shreveport
country: United States
facility: Willis Knighton River Cities Clinical Research Center
state: Louisiana
city: Pascagoula
country: United States
facility: Comprehensive Pain and Rehabilitation
state: Mississippi
city: Columbia
country: United States
facility: Columbia Interventional Pain Center, LLP
state: Missouri
city: Springfield
country: United States
facility: Mercy Medical Research Institute
state: Missouri
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: Cincinnati
country: United States
facility: Mayfield Clinic
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Cuyahoga Falls
country: United States
facility: Summa Western Reserve Hospital
state: Ohio
city: Greensburg
country: United States
facility: DNA Advanced Pain Treatment Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: Southern Spine Institute
state: South Carolina
city: Cedar Park
country: United States
facility: Austin Pain Associates
state: Texas
city: Webster
country: United States
facility: Space City Pain Specialists
state: Texas
city: Salt Lake City
country: United States
facility: Lifetree Clinical Research
state: Utah
city: Greenfield
country: United States
facility: Wisconsin Health Center Surgery Center
state: Wisconsin
Study officials:
affiliation: Mayfield Clinic, University of Cincinnati
name: George Mandybur, MD
role: PRINCIPAL_INVESTIGATOR
References: