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Trial record 1 of 48 for:    medtronic and back pain
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Spinal Cord Stimulation for Predominant Low Back Pain (PROMISE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01697358
First Posted: October 2, 2012
Last Update Posted: July 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
MedtronicNeuro
  Purpose
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
Intervention Model: Parallel Assignment
Intervention Model Description:
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.
Masking: None (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 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 Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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 Outcome Measures:
  • 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.


Enrollment: 278
Actual Study Start Date: January 8, 2013
Study Completion Date: June 20, 2017
Primary Completion Date: March 12, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SCS + OMM
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)
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: OMM alone
The investigator and subject will determine an individual Optimal Medical Management (OMM) treatment plan
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
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01697358


  Show 28 Study Locations
Sponsors and Collaborators
MedtronicNeuro
Investigators
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
First Submitted: September 25, 2012
First Posted: October 2, 2012
Results First Submitted: March 10, 2017
Results First Posted: June 14, 2017
Last Update Posted: July 21, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be kept confidential by Medtronic and only be shared with study investigators following Medtronic approval of a data request form.

Keywords provided by MedtronicNeuro:
FBSS
post laminectomy syndrome
SCS
RCT
back pain

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