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Spinal Cord Stimulation for Predominant Low Back Pain (PROMISE)

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ClinicalTrials.gov Identifier: NCT01697358
Recruitment Status : Completed
First Posted : October 2, 2012
Results First Posted : June 14, 2017
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Failed Back Surgery Syndrome
Back Pain
Pain in Leg, Unspecified
Interventions: Device: Spinal Cord Stimulation (SCS)
Drug: Optimal Medical Management (OMM)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 278 subjects were recruited between January 2013 and August 2015 from 28 sites in Canada, Colombia, Europe, and US.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 60 subjects didn't meet the inclusion and/or exclusion criteria and discontinued from the study before randomization.

Reporting Groups
  Description
SCS + OMM Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
OMM Alone Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects’ pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject’s original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.

Participant Flow for 2 periods

 Period 1:   Period I: Randomization to 6 Months
    SCS + OMM   OMM Alone
STARTED   110   108 
COMPLETED   97   107 
NOT COMPLETED   13   1 
Withdrawal by Subject                6                0 
Physician Decision                4                0 
Adverse Event                1                1 
Lost to Follow-up                2                0 

Period 2:   Period II: 6-24M Long-term Follow-up
    SCS + OMM   OMM Alone
STARTED   97   107 
COMPLETED   48   52 
NOT COMPLETED   49   55 
Physician Decision                3                12 
Withdrawal by Subject                8                10 
Lost to Follow-up                3                3 
Death                1                1 
Adverse Event                0                3 
Active subjects at the time of posting                34                26 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
SCS + OMM Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
OMM Alone Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects’ pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject’s original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
Total Total of all reporting groups

Baseline Measures
   SCS + OMM   OMM Alone   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 110   108   218 
Age 
[Units: Years]
Mean (Standard Deviation) 		 52.8  (12.5)   55.1  (10.2)   53.9  (11.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		     
Female      68  61.8%      64  59.3%      132  60.6% 
Male      42  38.2%      44  40.7%      86  39.4% 
Region of Enrollment 
[Units: Participants]
Count of Participants 		     
Belgium   25   24   49 
Canada   4   4   8 
Colombia   6   4   10 
France   12   13   25 
Germany   2   2   4 
Netherlands   6   6   12 
Spain   5   6   11 
United Kingdom   18   17   35 
United States   32   32   64 


  Outcome Measures

1.  Primary:   Compare Proportion of Subjects With ≥50% Reduction in Low Back Pain Intensity Between the Treatment Groups   [ Time Frame: 6 months post randomization ]
  Show Outcome Measure 1

2.  Secondary:   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 ]
  Show Outcome Measure 2

3.  Secondary:   Compare Change in Leg Pain Intensity, as Measured by the NPRS, Between the Treatment Groups   [ Time Frame: 6 months post randomization ]
  Show Outcome Measure 3

4.  Secondary:   Compare Change in Functional Disability, as Measured by the Oswestry Disability Index (ODI), Between the Treatment Groups   [ Time Frame: 6 months post randomization ]
  Show Outcome Measure 4

5.  Secondary:   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 ]
  Show Outcome Measure 5

6.  Other Pre-specified:   Compare Proportion of Subjects With ≥30% Reduction in Low Back Pain Intensity Between the Treatment Groups   [ Time Frame: 6 months post randomization ]
  Show Outcome Measure 6


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Restorative Therapies Group Clinical Trials
Organization: Medtronic Restorative Therapies Group - Pain Stim
e-mail: medtronicneurotrials@medtronic.com


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