Skip to main content
OpenTrials
Completed

NCT Number: NCT01697358

Spinal Cord 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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Failed Back Surgery Syndrome Back Pain Neurologic Manifestations Pain Pain in Leg, Unspecified Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms post laminectomy syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UCL St. Luc, Brussels, Belgium

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 6 months post randomization

    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.

Secondary outcomes

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

    Time frame: 6 months post randomization

    Compare change in low back pain intensity, as measured by the Numeric Pain Rating Scale (NPRS), from baseline to the end of Period I for subjects 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. Change in low back pain intensity is calculated as NPRS at baseline - NPRS at 6-month visit, with a positive change indicated as an improvement.

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

    Time frame: 6 months post randomization

    Compare change in leg pain intensity, as measured by the NPRS, from baseline to the end of Period I for subjects in the SCS group with that in the OMM group. Subjects reported average leg 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. Change in leg pain intensity is calculated as NPRS at baseline - NPRS at 6-month visit, with a positive change indicated as an improvement.

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

    Time frame: 6 months post randomization

    ODI is a validated questionnaire of 10 subject-reported sections on the ability to perform activities of daily living. These 10 sections are pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life (if applicable), social life, and traveling. Each section was scored on a 0 to 5 scale with 0 indicating no limitation of function due to pain and 5 indicating major functional disability due to back pain. A raw ODI score was calculated from the total score of 10 sections (minimum is 0 and maximum is 50). This ODI raw score was then normalized to a scale of 0 to 100, with 0-20 categorized as minimal disability, 20-40 as moderate disability, 40-60 as severe disability, 60-80 as severely disabled, and 80-100 as bed-bound patients. The ODI was assessed at baseline and subsequent scheduled study visits. Change in functional disability is calculated as ODI at baseline - ODI at 6-month visit, with a positive change indicated as an improvement.

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

    Time frame: 6 months post randomization

    The QoL scores were collected using the SF-36 questionnaire, which included the scores in the following 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health. The raw score of 0 represents poor health and 100 represents best health. The Physical Component Summary (PCS) score is a norm based score calculated from the raw scores of these 8 domains with a focus on physical health using 1998 US population. Change in PCS is calculated as PCS at 6-month visit - PCS at baseline, with a positive change indicated as an improvement.

Other outcomes

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

    Time frame: 6 months post randomization

    This additional analysis was pre-specified to support the analysis of primary objective. The 30% responder which is defined in the following paragraph was considered as clinical relevant to the SCS therapy in back pain. Compare the proportion of subjects with a ≥30% 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 ≥30% reduction in average low back pain were considered as 30% responders.

Sponsors and collaborators

Lead sponsor

MedtronicNeuro

Industry

Registry information

Official study title

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

Acronym: PROMISE

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Oct 2, 2012
Registry last updated
Jul 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.