Subcutaneous Nerve Stimulation for Failed Back Surgery Syndrome (FBSS) Patients

Not Applicable

Terminated

Conditions: Failed Back Surgery Syndrome
Post-laminectomy Syndrome

Interventions: Device: PrimeAdvanced® neurostimulator system

Registration Number: NCT01818297

Lead Sponsor: MedtronicNeuro

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 137

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	PrimeAdvanced® neurostimulator system	Treatment settings of Medtronic PrimeAdvanced® neurostimulator system implant
Control	PrimeAdvanced® neurostimulator system	Control settings of Medtronic PrimeAdvanced® neurostimulator system implant

Primary Outcome Measures

Name	Time	Method
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.	Baseline to 3 months	Number of responders in Treatment and Control groups. Subjects reported typical back pain (0=no pain, 10=worst pain) during the Baseline (BL) and Blinded Phase (M3) periods. Percentage reduction in average back pain was calculated as (BL-M3)/BL. Subjects with at least a 50% reduction in average back pain between Baseline and Month 3, with no increase in prescribed pain medications, were considered responders.

Secondary Outcome Measures

Name	Time	Method
Subject Satisfaction	3 months	Compare difference in number of subjects satisfied with therapy between the Treatment and Control groups at Month 3. Subjects who reported they were very or somewhat satisfied with the therapy were counted as satisfied. Subjects with no satisfaction response were excluded from the analysis.
Worst Back Pain	Baseline to 3 months	Compare the average improvement in worst back pain from Baseline to Month 3 between the Treatment and Control groups. Subjects reported worst back pain (0 (no pain) - 10 (worst pain)) during the Baseline and Blinded Phase (Month 3) periods. Change was calculated as Baseline - Month 3, with a positive change indicating improvement in worst back pain.
Quality of Life: Physical	Baseline to 3 months	Compare the average change in quality of life (as measured by Short Form Health Survey (SF36 v2): Physical component score (PCS)) from Baseline to Month 3 between subjects in the Treatment and Control groups. The PCS ranges from 0 (worst possible physicial quality of life) to 100 (best possible physical quality of life). Change was calculated as Month 3 - Baseline, with a positive difference indicating improvement in physical quality of life. Subjects with missing Baseline and/or Month 3 SF-36: PCS assessments were counted as no change (Month 3 - Baseline = 0).
Functional Disability	Baseline to 3 months	Compare the difference in average improvement in disability (as measured by Oswestry Disability Index (ODI)) from Baseline to Month 3 between the Treatment and Control groups. ODI ranges from 0% (no disability) -100% (greatest disability). Change is calculated as Baseline - Month 3 with a positive change indicating improvement in disability. Subjects with missing Baseline and/or Month 3 ODI assessments were counted as no change (Baseline - Month 3 = 0).
Quality of Life: Mental	Baseline to 3 months	Compare the average change in quality of life (as measured by Short Form Health Survey (SF36 v2): Mental component score (MCS)) from Baseline to Month 3 between subjects in the Treatment and Control groups. The MCS ranges from 0 (worst possible mental quality of life) to 100 (best possible mental quality of life). Change was calculated as Month 3 - Baseline, with a positive difference indicating improvement in mental quality of life. Subjects with missing Baseline and/or Month 3 SF-36: MCS assessments were counted as no change (Month 3 - Baseline = 0).

Trial Locations

Locations (27): University of Illinois at Chicago
🇺🇸
Chicago, Illinois, United States
Columbia Interventional Pain Center, LLP
🇺🇸
Columbia, Missouri, United States
Mercy Medical Research Institute
🇺🇸
Springfield, Missouri, United States
Valley Pain Consultants
🇺🇸
Phoenix, Arizona, United States
HOPE Research Institute
🇺🇸
Phoenix, Arizona, United States
Coastal Pain Research
🇺🇸
Carlsbad, California, United States
Pain Medicine Associates
🇺🇸
Fountain Valley, California, United States
Florida Pain Institute
🇺🇸
Merritt Island, Florida, United States
Advanced Medicine and Pain Management Research
🇺🇸
Miami, Florida, United States
Compass Research, LLC
🇺🇸
Orlando, Florida, United States
Emory University School of Medicine
🇺🇸
Atlanta, Georgia, United States
Willis Knighton River Cities Clinical Research Center
🇺🇸
Shreveport, Louisiana, United States
Comprehensive Pain and Rehabilitation
🇺🇸
Pascagoula, Mississippi, United States
University Hospitals Case Medical Center
🇺🇸
Cleveland, Ohio, United States
Mayfield Clinic
🇺🇸
Cincinnati, Ohio, United States
Ohio State University
🇺🇸
Columbus, Ohio, United States
Summa Western Reserve Hospital
🇺🇸
Cuyahoga Falls, Ohio, United States
DNA Advanced Pain Treatment Center
🇺🇸
Greensburg, Pennsylvania, United States
Southern Spine Institute
🇺🇸
Mount Pleasant, South Carolina, United States
Austin Pain Associates
🇺🇸
Cedar Park, Texas, United States
Space City Pain Specialists
🇺🇸
Webster, Texas, United States
Lifetree Clinical Research
🇺🇸
Salt Lake City, Utah, United States
Wisconsin Health Center Surgery Center
🇺🇸
Greenfield, Wisconsin, United States
NYU Langone Medical Center
🇺🇸
New York, New York, United States
Rush University Medical Center
🇺🇸
Chicago, Illinois, United States
Thomas Jefferson University
🇺🇸
Philadelphia, Pennsylvania, United States
University of Kansas Medical Center
🇺🇸
Kansas City, Kansas, United States