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

NCT01818297 | Terminated Results

• 2 other identifiers: 1666G120146
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 27

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.

Conditions

Failed Back Surgery Syndrome; Post-laminectomy Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Functional Disability

  Baseline to 3 months

• Subject Satisfaction

  3 months

• Quality of Life: Physical

  Baseline to 3 months

• Quality of Life: Mental

  Baseline to 3 months

• Worst Back Pain

  Baseline to 3 months

Study Arms (2)

Treatment

ACTIVE COMPARATOR

Treatment settings of Medtronic PrimeAdvanced® neurostimulator system implant

Device: PrimeAdvanced® neurostimulator system

Control

OTHER

Control settings of Medtronic PrimeAdvanced® neurostimulator system implant

Device: PrimeAdvanced® neurostimulator system

Interventions

PrimeAdvanced® neurostimulator system DEVICE

Neurostimulator and associated components

Control; Treatment

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MedtronicNeuro: lead

Study Sites (27)

Valley Pain Consultants

Phoenix, Arizona, 85001, United States

Location

HOPE Research Institute

Phoenix, Arizona, 85018, United States

Location

Coastal Pain Research

Carlsbad, California, 92009, United States

Location

Pain Medicine Associates

Fountain Valley, California, 92708, United States

Location

Florida Pain Institute

Merritt Island, Florida, 32953, United States

Location

Advanced Medicine and Pain Management Research

Miami, Florida, 33145, United States

Location

Compass Research, LLC

Orlando, Florida, 32806, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Willis Knighton River Cities Clinical Research Center

Shreveport, Louisiana, 71105, United States

Location

Comprehensive Pain and Rehabilitation

Pascagoula, Mississippi, 39581, United States

Location

Columbia Interventional Pain Center, LLP

Columbia, Missouri, 65201, United States

Location

Mercy Medical Research Institute

Springfield, Missouri, 65804, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Mayfield Clinic

Cincinnati, Ohio, 45219, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Summa Western Reserve Hospital

Cuyahoga Falls, Ohio, 44223, United States

Location

DNA Advanced Pain Treatment Center

Greensburg, Pennsylvania, 15601, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Southern Spine Institute

Mt. Pleasant, South Carolina, 29464, United States

Location

Austin Pain Associates

Cedar Park, Texas, 78613, United States

Location

Space City Pain Specialists

Webster, Texas, 77598, United States

Location

Lifetree Clinical Research

Salt Lake City, Utah, 84106, United States

Location

Wisconsin Health Center Surgery Center

Greenfield, Wisconsin, 53220, United States

Location

MeSH Terms

Conditions

Failed Back Surgery Syndrome; post laminectomy syndrome

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Limitations and Caveats

Due to early study termination prior to completion of planned enrollment, the summaries describe the available data, and no conclusions can be made on the efficacy of the therapy based on the data available.

Results Point of Contact

• Title: Neuro Clinical Trials
• Organization: Medtronic Neuromodulation

medtronicneurotrials@medtronic.com

Study Officials

• George Mandybur, MD

  Mayfield Clinic, University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2013
• First Posted: March 26, 2013
• Study Start: April 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: September 21, 2017
• Results First Posted: September 21, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (27)