Spinal Cord Stimulation for Predominant Low Back Pain

Back Pain Clinical Trial

— PROMISE  

Official title:

Prospective, Randomized Study of Multicolumn Implantable Lead Stimulation for Predominant Low Back Pain

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01697358
• Other study ID #: 1665
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 25, 2012
• Last updated: November 23, 2016
• Start date: January 2013

Study information

• Verified date: November 2016
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Description:

The study has a multi-center, prospective, randomized (1:1), open-label, parallel-group design of two alternative treatments:

• SCS group (SCS+OMM)

• OMM group

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Failed Back Surgery Syndrome
• Low Back Pain
• Pain in Leg, Unspecified

Intervention

Device:
• Spinal Cord Stimulation (SCS)
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.

Drug:
• Optimal Medical Management (OMM)
The investigator and subject will determine an individual OMM treatment plan, which should include non-investigational pharmacologic agents and/or therapies.

Locations

Country	Name	City	State
Belgium	UCL St. Luc	Brussels
Belgium	AZ St. Maarten	Duffel
Belgium	CHR Citadelle	Liège
Belgium	Heilig Hart Ziekenhuis	Roeselare
Belgium	Department of Neurosurgery: St. Augustinus Ziekenhuizen	Wilrijk
Canada	Regina General Hospital	Regina
Colombia	Clínica Las Américas	Medellin	Antioquia
Colombia	Hospital Pablo Tobón Uribe	Medellin	Antioquia
Colombia	San Vicente Fundación	Rionegro	Antioquia
France	Centre Hospitalier Universitaire de Poitiers	Poitiers Cedex
Germany	Städtisches Klinikum Görlitz gGmbH	Görlitz
Netherlands	St. Elisabeth Ziekenhuis Tilburg	Tilburg
Spain	Hospital Clinico Universitario de Valencia	Valencia
Spain	Hospital Clínico Universitario de Valladolid	Valladolid
United Kingdom	Nottingham University Hospital NHS Trust	Nottingham
United Kingdom	John Radcliffe Hospital Oxford	Oxford
United States	Albany Medical College	Albany	New York
United States	Duke Spine Center	Durham	North Carolina
United States	Kozmary Center for Pain Management	Las Vegas	Nevada
United States	West Virginia University	Morgantown	West Virginia
United States	Weill Medical College of Cornell University	New York	New York
United States	New York Spine and Wellness Center	North Syracuse	New York
United States	The Neuroscience Center	Ocean Springs	Mississippi
United States	Utah Spine Care	Ogden	Utah
United States	University of Rochester Neurosurgery Partners in Pain Management	Rochester	New York
United States	Pain Care LLC	Stockbridge	Georgia
United States	Richmond Bone and Joint Clinic	Sugar Land	Texas
United States	WellSpan Interventional Pain Center	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Colombia,  France,  Germany,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare proportion of subjects with =50% reduction in low back pain intensity		6 months post randomization	No
Secondary	Changes in pain intensity (measured by the Numeric Pain Rating Scale (NPRS)		6 months post randomization	No
Secondary	Changes in disability (measured by the Oswestry Disability Index (ODI)		6 months post randomization	No
Secondary	Changes in the quality of life (measured by the Short Form Health Survey (SF-36)		6 months post randomization	No