Spinal Cord Stimulation for Predominant Low Back Pain (PROMISE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by MedtronicNeuro
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT01697358
First received: September 25, 2012
Last updated: October 8, 2014
Last verified: October 2014

September 25, 2012
October 8, 2014
January 2013
April 2016   (final data collection date for primary outcome measure)
Compare proportion of subjects with ≥50% reduction in low back pain intensity [ Time Frame: 6 months post randomization ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01697358 on ClinicalTrials.gov Archive Site
  • Changes in pain intensity (measured by the Numeric Pain Rating Scale (NPRS) [ Time Frame: 6 months post randomization ] [ Designated as safety issue: No ]
  • Changes in disability (measured by the Oswestry Disability Index (ODI) [ Time Frame: 6 months post randomization ] [ Designated as safety issue: No ]
  • Changes in the quality of life (measured by the Short Form Health Survey (SF-36) [ Time Frame: 6 months post randomization ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Spinal Cord Stimulation for Predominant Low Back Pain
Prospective, Randomized Study of Multicolumn Implantable Lead Stimulation for Predominant Low Back Pain

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).

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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Failed Back Surgery Syndrome
  • Back Pain
  • Pain in Leg, Unspecified
  • 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.
  • Active Comparator: Spinal Cord Stimulation plus Optimal Medical Management
    Intervention: Device: Spinal Cord Stimulation (SCS)
  • Active Comparator: Optimal Medical Management (OMM)
    Intervention: Drug: Optimal Medical Management (OMM)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
Not Provided
April 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: PROMISE Clinical Research Study Team medtronicneurotrials@medtronic.com
Belgium,   France,   United States,   Spain,   United Kingdom,   Canada,   Netherlands,   Germany
 
NCT01697358
1665
No
MedtronicNeuro
MedtronicNeuro
Not Provided
Study Chair: Philippe Rigoard, MD, PhD University of Poitiers
MedtronicNeuro
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP