Trial record 2 of 2 for:
subqstim
SubQStim: A Post-market Study of Subcutaneous Nerve Stimulation in Failed Back Surgery Syndrome (FBSS) Patients
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| ClinicalTrials.gov Identifier: NCT01711619 |
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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
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Sponsor:
MedtronicNeuro
Information provided by (Responsible Party):
MedtronicNeuro
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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 |
| 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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: SQS plus OMM
subcutaneous nerve stimulation plus optimized medical management
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Device: subcutaneous nerve stimulation
subcutaneous nerve stimulation plus optimized medical management Other: Optimized Medical Management Optimized medical management |
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Active Comparator: OMM
optimized medical management
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Other: Optimized Medical Management
Optimized medical management |
Primary Outcome Measures :
- 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 :
- 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.
- 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.
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Provides written Patient Informed Consent/Patient Information Sheet prior to study-related activities being conducted
- ≥ 18 years of age at time of informed consent
- Willing and available to attend visits as scheduled and to comply with the study protocol
- Willing and able to undergo assessments as part of the evaluation for eligibility and endpoints
- Willing and able to use the external neurostimulator, recharging equipment (if applicable), and patient programmer per the schedule required by the protocol
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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
- 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))
- Is an appropriate implant candidate for the SQS system
Exclusion Criteria:
- Has been or is currently being treated with spinal cord stimulation, subcutaneous nerve stimulation, peripheral nerve stimulation or an implantable intrathecal drug delivery system
- 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
- Has a pain condition unrelated to FBSS that is severe enough to overshadow the FBSS pain in the opinion of the investigator
- Spinal instability or anatomic compression that requires further surgery
- Spinal fusion at more than 3 vertebral levels
- Currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound the results of this study
- Allergic or has shown hypersensitivity to any materials of the device system which come in contact with the body
- History of coagulation disorder or lupus erythematosus
- 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 26 study locations
Sponsors and Collaborators
MedtronicNeuro
Investigators
| Principal Investigator: | Sam Eldabe, MD | The James Cook Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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:
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Syndrome Failed Back Surgery Syndrome Disease Pathologic Processes |
Postoperative Complications Back Pain Pain Neurologic Manifestations |