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

Primary Purpose

Failed Back Surgery Syndrome, Post-laminectomy Syndrome

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PrimeAdvanced® neurostimulator system
Sponsored by
MedtronicNeuro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Failed Back Surgery Syndrome

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Valley Pain Consultants
  • HOPE Research Institute
  • Coastal Pain Research
  • Pain Medicine Associates
  • Florida Pain Institute
  • Advanced Medicine and Pain Management Research
  • Compass Research, LLC
  • Emory University School of Medicine
  • Rush University Medical Center
  • University of Illinois at Chicago
  • University of Kansas Medical Center
  • Willis Knighton River Cities Clinical Research Center
  • Comprehensive Pain and Rehabilitation
  • Columbia Interventional Pain Center, LLP
  • Mercy Medical Research Institute
  • NYU Langone Medical Center
  • Mayfield Clinic
  • University Hospitals Case Medical Center
  • Ohio State University
  • Summa Western Reserve Hospital
  • DNA Advanced Pain Treatment Center
  • Thomas Jefferson University
  • Southern Spine Institute
  • Austin Pain Associates
  • Space City Pain Specialists
  • Lifetree Clinical Research
  • Wisconsin Health Center Surgery Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Treatment

Control

Arm Description

Treatment settings of Medtronic PrimeAdvanced® neurostimulator system implant

Control settings of Medtronic PrimeAdvanced® neurostimulator system implant

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
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).
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).
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.

Full Information

First Posted
March 21, 2013
Last Updated
September 19, 2017
Sponsor
MedtronicNeuro
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1. Study Identification

Unique Protocol Identification Number
NCT01818297
Brief Title
Subcutaneous Nerve Stimulation for Failed Back Surgery Syndrome (FBSS) Patients
Acronym
SubQStim
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

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision
Study Start Date
April 2013 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedtronicNeuro

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Failed Back Surgery Syndrome, Post-laminectomy Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
137 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Active Comparator
Arm Description
Treatment settings of Medtronic PrimeAdvanced® neurostimulator system implant
Arm Title
Control
Arm Type
Other
Arm Description
Control settings of Medtronic PrimeAdvanced® neurostimulator system implant
Intervention Type
Device
Intervention Name(s)
PrimeAdvanced® neurostimulator system
Intervention Description
Neurostimulator and associated components
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Baseline to 3 months
Secondary Outcome Measure Information:
Title
Functional Disability
Description
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).
Time Frame
Baseline to 3 months
Title
Subject Satisfaction
Description
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.
Time Frame
3 months
Title
Quality of Life: Physical
Description
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).
Time Frame
Baseline to 3 months
Title
Quality of Life: Mental
Description
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).
Time Frame
Baseline to 3 months
Title
Worst Back Pain
Description
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.
Time Frame
Baseline to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Mandybur, MD
Organizational Affiliation
Mayfield Clinic, University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Valley Pain Consultants
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85001
Country
United States
Facility Name
HOPE Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Coastal Pain Research
City
Carlsbad
State/Province
California
ZIP/Postal Code
92009
Country
United States
Facility Name
Pain Medicine Associates
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Florida Pain Institute
City
Merritt Island
State/Province
Florida
ZIP/Postal Code
32953
Country
United States
Facility Name
Advanced Medicine and Pain Management Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33145
Country
United States
Facility Name
Compass Research, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Willis Knighton River Cities Clinical Research Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Comprehensive Pain and Rehabilitation
City
Pascagoula
State/Province
Mississippi
ZIP/Postal Code
39581
Country
United States
Facility Name
Columbia Interventional Pain Center, LLP
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
Mercy Medical Research Institute
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mayfield Clinic
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Summa Western Reserve Hospital
City
Cuyahoga Falls
State/Province
Ohio
ZIP/Postal Code
44223
Country
United States
Facility Name
DNA Advanced Pain Treatment Center
City
Greensburg
State/Province
Pennsylvania
ZIP/Postal Code
15601
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Southern Spine Institute
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Austin Pain Associates
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613
Country
United States
Facility Name
Space City Pain Specialists
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Lifetree Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Wisconsin Health Center Surgery Center
City
Greenfield
State/Province
Wisconsin
ZIP/Postal Code
53220
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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