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

SubQStim Pivotal Study: A Prospective, Randomized, Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Nerve Stimulation. Protocol 1666

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.

Study Overview

• Status: Terminated
• Conditions: Failed Back Surgery Syndrome; Post-laminectomy Syndrome
• Intervention / Treatment: Device: PrimeAdvanced® neurostimulator system

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 137
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85018
      • HOPE Research Institute
    • Phoenix, Arizona, United States, 85001
      • Valley Pain Consultants
  • California
    • Carlsbad, California, United States, 92009
      • Coastal Pain Research
    • Fountain Valley, California, United States, 92708
      • Pain Medicine Associates
  • Florida
    • Merritt Island, Florida, United States, 32953
      • Florida Pain Institute
    • Miami, Florida, United States, 33145
      • Advanced Medicine and Pain Management Research
    • Orlando, Florida, United States, 32806
      • Compass Research, LLC
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University School Of Medicine
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Louisiana
    • Shreveport, Louisiana, United States, 71105
      • Willis Knighton River Cities Clinical Research Center
  • Mississippi
    • Pascagoula, Mississippi, United States, 39581
      • Comprehensive Pain and Rehabilitation
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Columbia Interventional Pain Center, LLP
    • Springfield, Missouri, United States, 65804
      • Mercy Medical Research Institute
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Mayfield Clinic
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Case Medical Center
    • Columbus, Ohio, United States, 43210
      • Ohio State University
    • Cuyahoga Falls, Ohio, United States, 44223
      • Summa Western Reserve Hospital
  • Pennsylvania
    • Greensburg, Pennsylvania, United States, 15601
      • DNA Advanced Pain Treatment Center
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
  • South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
      • Southern Spine Institute
  • Texas
    • Cedar Park, Texas, United States, 78613
      • Austin Pain Associates
    • Webster, Texas, United States, 77598
      • Space City Pain Specialists
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • Lifetree Clinical Research
  • Wisconsin
    • Greenfield, Wisconsin, United States, 53220
      • Wisconsin Health Center Surgery Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment; Treatment settings of Medtronic PrimeAdvanced® neurostimulator system implant	Device: PrimeAdvanced® neurostimulator system; Neurostimulator and associated components
Other: Control; Control settings of Medtronic PrimeAdvanced® neurostimulator system implant	Device: PrimeAdvanced® neurostimulator system; Neurostimulator and associated components

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Disability	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).	Baseline to 3 months
Subject Satisfaction	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.	3 months
Quality of Life: Physical	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).	Baseline to 3 months
Quality of Life: Mental	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).	Baseline to 3 months
Worst Back Pain	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.	Baseline to 3 months

Collaborators and Investigators

• Sponsor: MedtronicNeuro
• Investigators: Principal Investigator: George Mandybur, MD, Mayfield Clinic, University of Cincinnati

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: March 21, 2013
• First Submitted That Met QC Criteria: March 21, 2013
• First Posted (Estimate): March 26, 2013

Study Record Updates

• Last Update Posted (Actual): September 21, 2017
• Last Update Submitted That Met QC Criteria: September 19, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Disease; Back Pain; Syndrome; Failed Back Surgery Syndrome
• Other Study ID Numbers: 1666; G120146 (Other Identifier: FDA Protocol Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO