Spinal Cord Stimulation for Predominant Low Back Pain (PROMISE)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: September 25, 2012
Last updated: May 9, 2016
Last verified: May 2016
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).

Condition Intervention Phase
Failed Back Surgery Syndrome
Back Pain
Pain in Leg, Unspecified
Device: Spinal Cord Stimulation (SCS)
Drug: Optimal Medical Management (OMM)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective, Randomized Study of Multicolumn Implantable Lead Stimulation for Predominant Low Back Pain

Resource links provided by NLM:

Further study details as provided by MedtronicNeuro:

Primary Outcome Measures:
  • Compare proportion of subjects with ≥50% reduction in low back pain intensity [ Time Frame: 6 months post randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: January 2013
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Spinal Cord Stimulation plus Optimal Medical Management 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.
Active Comparator: Optimal Medical Management (OMM) 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.

Detailed 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01697358

  Show 29 Study Locations
Sponsors and Collaborators
Study Chair: Philippe Rigoard, MD, PhD University of Poitiers
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT01697358     History of Changes
Other Study ID Numbers: 1665 
Study First Received: September 25, 2012
Last Updated: May 9, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by MedtronicNeuro:
post laminectomy syndrome
back pain

Additional relevant MeSH terms:
Back Pain
Failed Back Surgery Syndrome
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Postoperative Complications
Signs and Symptoms

ClinicalTrials.gov processed this record on May 26, 2016