Status:
TERMINATED
Subcutaneous Nerve Stimulation for Failed Back Surgery Syndrome (FBSS) Patients
Lead Sponsor:
MedtronicNeuro
Conditions:
Failed Back Surgery Syndrome
Post-laminectomy Syndrome
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
The purpose of this study is to assess the safety and efficacy of Subcutaneous Nerve Stimulation (SQS) (also known as Peripheral Nerve Stimulation \[PNS\]) in the reduction of chronic, intractable pos...
Detailed Description
This study is a multi-center, prospective, randomized (1:1) parallel-group design.
Eligibility Criteria
Inclusion
- Key
- Have persistent back pain for at least 6 months
- Had back surgery at least 6 months ago
- Have tried pain medications and physical therapy
- Read and understand written English or Spanish
- Male or non-pregnant female. If female of child-bearing potential, and if sexually active, must be using a medically-acceptable method of birth control during study participation
- Willing and able to undergo surgical implant procedure, attend visits as scheduled, and comply with the study requirements
- Have an expected lifespan greater than 12 months
- Key
Exclusion
- Have leg pain in addition to back pain.
- Currently enrolled in or plan to enroll in another drug and/or device study
- Have peripheral vascular disease, peripheral neuropathy, small-fiber neuropathy, or fibromyalgia
- Have an active systemic infection or are immunocompromised
- Will be exposed to diathermy or anticipate needing a full-body MRI scan
- Currently have an implantable cardiac pacemaker, defibrillator, or neurostimulator
- Treated with spinal cord stimulation, peripheral nerve stimulation, an intrathecal drug delivery system or requires additional back surgery
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT01818297
Start Date
April 1 2013
End Date
March 1 2016
Last Update
September 21 2017
Active Locations (27)
Enter a location and click search to find clinical trials sorted by distance.
1
Valley Pain Consultants
Phoenix, Arizona, United States, 85001
2
HOPE Research Institute
Phoenix, Arizona, United States, 85018
3
Coastal Pain Research
Carlsbad, California, United States, 92009
4
Pain Medicine Associates
Fountain Valley, California, United States, 92708