Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 2 for:    subqstim

SubQStim: A Post-market Study of Subcutaneous Nerve Stimulation in Failed Back Surgery Syndrome (FBSS) Patients

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.
 
ClinicalTrials.gov Identifier: NCT01711619
Recruitment Status : Terminated (Challenges to recruit qualified participants)
First Posted : October 22, 2012
Results First Posted : October 22, 2018
Last Update Posted : October 22, 2018
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro

Brief Summary:
The purpose of this study is to compare the effectiveness of peripheral nerve stimulation utilizing a subcutaneous lead implant technique (SQS) plus optimized medical management (OMM) versus OMM alone in patients suffering from back pain due to Failed Back Surgery Syndrome (FBSS).

Condition or disease Intervention/treatment Phase
Failed Back Surgery Syndrome Device: subcutaneous nerve stimulation Other: Optimized Medical Management Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interventional, Prospective, Multicenter, Randomized, Parallel-arm Study to Compare the Effectiveness of Peripheral Nerve Stimulation (PNS) Utilizing a Subcutaneous Lead Implant Technique (SQS) Plus Optimized Medical Management (OMM) Versus OMM Alone in Patients Suffering From Back Pain Due to Failed Back Surgery Syndrome (FBSS)
Study Start Date : November 2012
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: SQS plus OMM
subcutaneous nerve stimulation plus optimized medical management
Device: subcutaneous nerve stimulation
subcutaneous nerve stimulation plus optimized medical management

Other: Optimized Medical Management
Optimized medical management

Active Comparator: OMM
optimized medical management
Other: Optimized Medical Management
Optimized medical management




Primary Outcome Measures :
  1. Effectiveness of Treatment on Reduction of Back Pain Intensity [ Time Frame: 9 months ]
    Percentage of participants who responded to the treatment, where response was defined as ≥ 50% reduction in back pain intensity as measured by Visual Analog Scale from baseline to the 9-month follow-up visit. Pain intensity was measured by a 100 mm Visual Analog Scale, with 0 representing no pain and 100 representing the worst pain imaginable.


Secondary Outcome Measures :
  1. Average Change in Back Pain Intensity [ Time Frame: 6 and 9 months ]
    Average change in back pain intensity from baseline to the 6 and 9-month follow-up visits. Pain intensity was measured by a 100 mm Visual Analog Scale, with 0 representing no pain and 100 representing the worst pain imaginable. A reduction in average pain score is indicated by a negative number.

  2. Back Pain Responder Rate (≥50%) at 6 Months [ Time Frame: 6 months ]
    Percentage of participants who responded to the treatment, where response was defined as ≥ 50% reduction in back pain intensity as measured by Visual Analog Scale from baseline to the 6-month follow-up visit. Pain intensity was measured by a 100 mm Visual Analog Scale, with 0 representing no pain and 100 representing the worst pain imaginable.

  3. Back Pain Responder Rate (≥30%) at 9 Months [ Time Frame: 9 months ]
    Percentage of participants who responded to the treatment, where response was defined as ≥ 30% reduction in back pain intensity as measured by Visual Analog Scale from baseline to the 9-month follow-up visit. Pain intensity was measured by a 100 mm Visual Analog Scale, with 0 representing no pain and 100 representing the worst pain imaginable.



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provides written Patient Informed Consent/Patient Information Sheet prior to study-related activities being conducted
  2. ≥ 18 years of age at time of informed consent
  3. Willing and available to attend visits as scheduled and to comply with the study protocol
  4. Willing and able to undergo assessments as part of the evaluation for eligibility and endpoints
  5. Willing and able to use the external neurostimulator, recharging equipment (if applicable), and patient programmer per the schedule required by the protocol
  6. Diagnosed with FBSS (i.e.):

    • Has had persistent pain for 6 months following most recent anatomically correct, successful surgery AND
    • There are no further therapeutic surgical options available as assessed by appropriate investigation
  7. Back pain is considered intractable and has been adequately treated (failed an appropriate trial of at least 3 different classes of back pain treatments (pharmaceutical and/or non-pharmaceutical))
  8. Is an appropriate implant candidate for the SQS system

Exclusion Criteria:

  1. Has been or is currently being treated with spinal cord stimulation, subcutaneous nerve stimulation, peripheral nerve stimulation or an implantable intrathecal drug delivery system
  2. Evidence of an active disruptive psychiatric disorder that is significant enough to impact the perception of pain, compliance to intervention and/or ability to evaluate treatment outcome, as determined by the investigator
  3. Has a pain condition unrelated to FBSS that is severe enough to overshadow the FBSS pain in the opinion of the investigator
  4. Spinal instability or anatomic compression that requires further surgery
  5. Spinal fusion at more than 3 vertebral levels
  6. Currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound the results of this study
  7. Allergic or has shown hypersensitivity to any materials of the device system which come in contact with the body
  8. History of coagulation disorder or lupus erythematosus
  9. Involved in current litigation regarding back pain

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): NCT01711619


Locations
Show Show 26 study locations
Sponsors and Collaborators
MedtronicNeuro
Investigators
Layout table for investigator information
Principal Investigator: Sam Eldabe, MD The James Cook Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT01711619    
Other Study ID Numbers: 1.02.7007
First Posted: October 22, 2012    Key Record Dates
Results First Posted: October 22, 2018
Last Update Posted: October 22, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Syndrome
Failed Back Surgery Syndrome
Disease
Pathologic Processes
Postoperative Complications
Back Pain
Pain
Neurologic Manifestations