Spinal Cord Stimulation for Predominant Low Back Pain

NCT01697358 | Completed Phase 4 Results

• 1 other identifier: 1665
• Study Type: interventional
• Target: 278
• Locations: 9 countries
• Sites: 28

Brief Summary

The purpose of this study is to compare the effectiveness of spinal cord stimulation (SCS) using the Medtronic Specify® 5-6-5 multicolumn surgical lead plus optimal medical management (OMM) versus OMM alone in patients suffering from predominant low back pain due to failed back surgery syndrome (FBSS).

Conditions

Failed Back Surgery Syndrome; Back Pain; Pain in Leg, Unspecified

Keywords

FBSS; post laminectomy syndrome; SCS; RCT; back pain

Outcome Measures

Primary Outcomes (1)

• Compare Proportion of Subjects With ≥50% Reduction in Low Back Pain Intensity Between the Treatment Groups

  Compare the proportion of subjects with a ≥50% reduction in low back pain intensity, as measured by the NPRS, from baseline to the end of Period I in the SCS group with that in the OMM group. Subjects reported average low back pain using a 11-point NPRS pain diary (0 = no back pain, 10 = worst low back pain imaginable) two times per day for a 7-day period at baseline and prior to 6-month visit. Percent reduction in low back pain intensity was calculated as average NPRS at (6-month visit - baseline) / baseline. Subjects with ≥50% reduction in average low back pain were considered as responders.

  6 months post randomization

Secondary Outcomes (4)

• Compare Change in Low Back Pain Intensity, as Measured by the Numeric Pain Rating Scale (NPRS), Between the Treatment Groups

  6 months post randomization

• Compare Change in Leg Pain Intensity, as Measured by the NPRS, Between the Treatment Groups

  6 months post randomization

• Compare Change in Functional Disability, as Measured by the Oswestry Disability Index (ODI), Between the Treatment Groups

  6 months post randomization

• Compare Change in Quality of Life (QoL), as Measured by the SF-36 Physical Component Summary (PCS), Between the Treatment Groups

  6 months post randomization

Other Outcomes (1)

• Compare Proportion of Subjects With ≥30% Reduction in Low Back Pain Intensity Between the Treatment Groups

  6 months post randomization

Study Arms (2)

SCS + OMM

ACTIVE COMPARATOR

Spinal Cord Stimulation (SCS) using the Medtronic Specify 5-6-5 multicolumn surgical lead plus an individual Optimal Medical Management (OMM) treatment plan

Device: Spinal Cord Stimulation (SCS); Drug: Optimal Medical Management (OMM)

OMM alone

ACTIVE COMPARATOR

The investigator and subject will determine an individual Optimal Medical Management (OMM) treatment plan

Drug: Optimal Medical Management (OMM)

Interventions

Spinal Cord Stimulation (SCS) DEVICE

Spinal Cord Stimulation (SCS) using the Medtronic Specify 5-6-5 multicolumn surgical lead. Subjects will undergo an SCS screening test and, if successful, an implantable neurostimulation system implant. Any SCS group subject not implanted will continue to be treated with OMM and will be followed as part of the SCS group.

SCS + OMM

Optimal Medical Management (OMM) DRUG

The investigator and subject will determine an individual OMM treatment plan, which should include non-investigational pharmacologic agents and/or therapies.

OMM alone; SCS + OMM

Eligibility Criteria

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

You may qualify if:

• SCS candidate with the Specify 5-6-5 surgical lead
• Has FBSS and does not require further surgery (defined as persistent or recurrent low back and leg pain of at least 6 months duration following at least one decompression and/or fusion procedure)
• Average low back pain is ≥ 5 as assessed by the baseline NPRS
• Average low back pain is greater than leg pain
• Subject has persistent moderate to severe low back and leg pain despite other treatments

You may not qualify if:

• Treated with SCS, subcutaneous or peripheral nerve stimulation, an intrathecal drug delivery system, requires back surgery at the location related to his/her original back pain complaint or experimental therapies
• Most recent back surgery \< 6 months ago
• Low back pain only (no leg pain)
• Investigator suspects substance abuse that might confound the study results
• Radiographic evidence of instability requiring fusion
• Pain relieved completely by lying down
• Life expectancy of \< 24 months
• Subject is pregnant or planning to become pregnant during the course of the study
• Subject is unable to undergo study assessments or complete questionnaires independently

Sponsors & Collaborators

• MedtronicNeuro: lead

Study Sites (28)

Pain Care LLC

Stockbridge, Georgia, 30281, United States

Location

The Neuroscience Center

Ocean Springs, Mississippi, 39564, United States

Location

Kozmary Center for Pain Management

Las Vegas, Nevada, 89102, United States

Location

Albany Medical College

Albany, New York, 12208, United States

Location

Weill Medical College of Cornell University

New York, New York, 10021-9800, United States

Location

New York Spine and Wellness Center

North Syracuse, New York, 13212, United States

Location

University of Rochester Neurosurgery Partners in Pain Management

Rochester, New York, 14618, United States

Location

Duke Spine Center

Durham, North Carolina, 27710, United States

Location

WellSpan Interventional Pain Center

York, Pennsylvania, 17402, United States

Location

Richmond Bone and Joint Clinic

Sugar Land, Texas, 77478, United States

Location

Utah Spine Care

Ogden, Utah, 84403, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

UCL St. Luc

Brussels, 1200, Belgium

Location

AZ St. Maarten

Duffel, 2570, Belgium

Location

CHR Citadelle

Liège, 4000, Belgium

Location

Heilig Hart Ziekenhuis

Roeselare, 8800, Belgium

Location

Department of Neurosurgery: St. Augustinus Ziekenhuizen

Wilrijk, 2610, Belgium

Location

Regina General Hospital

Regina, S4P 0W5, Canada

Location

Clínica Las Américas

Medellín, Antioquia, 050025, Colombia

Location

Hospital Pablo Tobón Uribe

Medellín, Antioquia, Colombia

Location

San Vicente Fundación

Rionegro, Antioquia, 054047, Colombia

Location

Centre Hospitalier Universitaire de Poitiers

Poitiers, 86021, France

Location

Städtisches Klinikum Görlitz gGmbH

Görlitz, 02828, Germany

Location

St. Elisabeth Ziekenhuis Tilburg

Tilburg, 5022 GC, Netherlands

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

Hospital Clínico Universitario de Valladolid

Valladolid, 47005, Spain

Location

Nottingham University Hospital NHS Trust

Nottingham, NG7 2UH, United Kingdom

Location

John Radcliffe Hospital Oxford

Oxford, OX3 9DU, United Kingdom

Location

Related Publications (3)

• O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.

  PMID: 34854473 DERIVED

• Rigoard P, Basu S, Desai M, Taylor R, Annemans L, Tan Y, Johnson MJ, Van den Abeele C, North R; PROMISE Study Group. Multicolumn spinal cord stimulation for predominant back pain in failed back surgery syndrome patients: a multicenter randomized controlled trial. Pain. 2019 Jun;160(6):1410-1420. doi: 10.1097/j.pain.0000000000001510.

  PMID: 30720582 DERIVED

• Rigoard P, Desai MJ, North RB, Taylor RS, Annemans L, Greening C, Tan Y, Van den Abeele C, Shipley J, Kumar K. Spinal cord stimulation for predominant low back pain in failed back surgery syndrome: study protocol for an international multicenter randomized controlled trial (PROMISE study). Trials. 2013 Nov 7;14:376. doi: 10.1186/1745-6215-14-376.

  PMID: 24195916 DERIVED

MeSH Terms

Conditions

Failed Back Surgery Syndrome; Back Pain; post laminectomy syndrome

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Results Point of Contact

• Title: Restorative Therapies Group Clinical Trials
• Organization: Medtronic Restorative Therapies Group - Pain Stim

medtronicneurotrials@medtronic.com

Study Officials

• Philippe Rigoard, MD, PhD

  University of Poitiers

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Period I (from randomization to 6 months) is the randomized parallel group comparative phase. Day zero for the study is the point of randomization. The randomization ratio is 1:1 (SCS+OMM to OMM). For the SCS+OMM arm, the screening test and/or implant occurred after randomization. Period II (6 to 24 months) is the long-term observational follow-up phase.

Study Record Dates

• First Submitted: September 25, 2012
• First Posted: October 2, 2012
• Study Start: January 8, 2013
• Primary Completion: March 12, 2016
• Study Completion: June 20, 2017
• Last Updated: July 21, 2017
• Results First Posted: June 14, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

CO (3); CA (1); GB (2); US (12); BE (5); ES (2); NL (1); DE (1); FR (1)