Clinical trials: Failed Back Surgery Syndrome (FBSS)
Pain, Intractable
OPTIONS Spinal Cord Stimulation Programming Parameters
The purpose of this study is to evaluate programming options in spinal cord stimulation for the management of chronic, intractable pain of the trunk and limbs.
- Trial name
- NCT02503787
- Testing
- Spinal Cord Stimulation (SCS)
- Where
- 11 sites in United States
- Volunteers
- 64 people
- Sponsor
- MedtronicNeuro
Pain, Chronic, Pain, Intractable
Spinal Cord Stimulation in the Treatment of Chronic, Intractable Pain Using the Nalu™ Neurostimulation System
The Nalu Neurostimulation System is capable of delivering multiple therapy options to address patient needs. The study will confirm the efficacy, safety, comfort and compliance with the Nalu Neurostimulation System in adult…
- Conditions
- Pain, Chronic, Pain, Intractable, Pain, Back
- Trial name
- nPower™-US (NCT04503109)
- Testing
- Nalu Neurostimulation System
- Where
- 8 sites in United States
- Volunteers
- 110 people
- Sponsor
- Nalu Medical, Inc.
Failed Back Surgery Syndrome, Complex Regional Pain Syndrome (CRPS)
A Study to Confirm the Safety of High Frequency DRG Stimulator in Patients With Chronic Lower Limb Pain
This study is a prospective, single-arm, open label, single center pilot study to confirm the safety of a ultrahigh frequency DRG stimulator in patients with chronic lower limb pain. The actual trial length is 5 days.
- Trial name
- NCT03285113
- Testing
- GiMer Medical MN 1000 External Stimulator
- Where
- Taiwan
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- GiMer Medical
Failed Back Surgery Syndrome
A Post Market Study on DRG Stimulation in FBSS (SYMPATHY)
The purpose of this Post Market Observational Study is to monitor the effect of the Axium® SCS System in the management of chronic pain following surgical lumbar discectomy in subjects whom are routinely scheduled for treatment…
- Trial name
- NCT02634398
- Where
- Switzerland
- Sponsor
- Abbott Medical Devices
Failed Back Surgery Syndrome, Back Pain
Spinal Cord Stimulation for Predominant Low Back Pain
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…
- Conditions
- Failed Back Surgery Syndrome, Back Pain, Pain in Leg, Unspecified
- Trial name
- PROMISE (NCT01697358)
- Testing
- Spinal Cord Stimulation (SCS), Optimal Medical Management (OMM)
- Where
- 28 sites in United States, Belgium and 7 more
- Volunteers
- 278 people
- Sponsor
- MedtronicNeuro
Chronic Pain, Pain, Intractable
An Implantable Spinal Cord Stimulation Pain Management System
There are many treatment options available for the management of chronic pain . Some include, but are not limited to, over-the-counter medications, Non-Steroidal Anti-Inflammatory Drugs, Physical Therapy, Transcutaneous…
- Conditions
- Chronic Pain, Pain, Intractable, Pain, Back Pain
- Trial name
- NCT00205855
- Testing
- Precision SCS
- Where
- 9 sites in United States
- Volunteers
- 65 people
- Sponsor
- Boston Scientific Corporation
Failed Back Surgery Syndrome
Spinal Cord Stimulation Frequency Study
The purpose of this study is to evaluate the role of frequency settings on spinal cord stimulation in the management of Failed Back Surgery Syndrome (SCS Frequency Study).
- Trial name
- NCT01750229
- Testing
- 1200 Hz, 3030 Hz, 5882 Hz
- Where
- United Kingdom
- Volunteers
- 53 people
- Sponsor
- MedtronicNeuro
Chronic Pain
Evaluate St Jude Medical Prodigy Neuromodulation for FBSS or Chronic Pain of the Trunk and/or Limbs
The purpose of this study is to confirm long term efficacy and safety of the ProdigyTM neuromodulation system in the management of failed back surgery syndrome or chronic intractable pain of the trunk and/or limbs.
- Trial name
- Prodigy-I (NCT02143791)
- Testing
- Burst and Tonic stimulation
- Where
- 21 sites in Australia, Belgium and 7 more
- Volunteers
- 126 people
- Sponsor
- Abbott Medical Devices
Failed Back Surgery Syndrome
Efficacy Study of the Octapolar Lead in Patients With Failed Back Surgery Syndrome (FBSS) With Chronic Pain
Spinal cord stimulation (SCS) has been used for over 40 years to treat neuropathic pain. Various clinical studies have shown a beneficial effect of SCS on pain in patients with Failed Back Surgery Syndrome (FBSS).
- Trial name
- NCT01096147
- Testing
- Spinal cord stimulation with eight polar electrode
- Where
- 8 sites in Belgium, Norway and 1 more
- Volunteers
- 80 people
- Sponsor
- Rik Buschman, PhD
Failed Back Surgery Syndrome, Pain
Spinal Cord Stimulation With Precision® System Versus Reoperation for Failed Back Surgery Syndrome
The EVIDENCE trial is a randomized controlled trial comparing the therapeutic effectiveness and cost-effectiveness of the Precision® Spinal Cord Stimulation with that of reoperation as a treatment of pain in patients with Failed…
- Conditions
- Failed Back Surgery Syndrome, Pain, Back Pain
- Trial name
- Evidence (NCT01036529)
- Testing
- Precision Spinal Cord Stimulator, Back Surgery
- Where
- 18 sites in United States, Canada and 2 more
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Boston Scientific Corporation
Failed Back Surgery Syndrome, Post-laminectomy Syndrome
Subcutaneous Nerve Stimulation for Failed Back Surgery Syndrome (FBSS) Patients
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 post-surgical back pain in adults.
- Trial name
- SubQStim (NCT01818297)
- Testing
- PrimeAdvanced® neurostimulator system
- Where
- 27 sites in United States
- Volunteers
- 137 people
- Sponsor
- MedtronicNeuro
Chronic Refractory Pain Associated With Failed Back Surgery Syndrome, Epidural Fibrosis, Peripheral Causalgia, Complex Regional Pain Syndrome
Restore Claims Characterization Study
The purpose of this study is to characterize the pain coverage capability of the RESTORE spinal cord stimulation (SCS) and assess health outcomes.
- Trial name
- NCT00200122
- Testing
- Spinal Cord Stimulation
- Where
- 8 sites in United States
- Volunteers
- 100 people
- Sponsor
- MedtronicNeuro
Failed Back Surgery Syndrome, Post-Laminectomy Syndrome
SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation) Study
The purpose of the study is to demonstrate safety and efficacy of spinal cord stimulation with peripheral nerve field stimulation for the treatment of chronic low back and leg pain.
- Conditions
- Failed Back Surgery Syndrome, Post-Laminectomy Syndrome, Low Back Pain
- Trial name
- SENSE (NCT01990287)
- Testing
- SCS and PNfS, SCS Alone
- Where
- 28 sites in United States
- Volunteers
- 38 people
- Sponsor
- Abbott Medical Devices
Back Pain
Comparison of Intraspinal Nerve Root Stimulation With Dorsal Column Stimulation
This study will systematically evaluate the programming parameters of the Precision Spinal Cord Stimulation Device to optimally relieve pain while minimizing any uncomfortable side effects.
- Trial name
- NCT00370773
- Testing
- Precision Spinal Cord Stimulation System
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Boston Scientific Corporation
Degenerative Disc Disease, Herniated Disc
Bone Graft Materials Observational Registry
A multi-center, prospective, observational patient registry to collect information on the clinical outcomes and "real world" use of approved and commercially available bone graft substitutes, autograft and allograft.
- Conditions
- Degenerative Disc Disease, Herniated Disc, Spinal Stenosis, Spondylolithesis
- Trial name
- APPROACH-001 (NCT00974623)
- Testing
- Bone graft substitute, autograft or allograft
- Where
- 14 sites in United States, Hungary and 1 more
- Volunteers
- 329 people
- Sponsor
- Baxter Healthcare Corporation
Failed Back Surgery Syndrome
A Post Market Study on Dorsal Root Ganglion (DRG) Stimulation in Failed Back Surgery Syndrome (FBSS)
18-SMI-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of chronic pain following lumbar discectomy (Failed Back…
- Trial name
- SYMPATHY (NCT02335216)
- Testing
- Implantation with the commercially available Axium neurostimulator
- Where
- Netherlands
- Volunteers
- 22 people
- Sponsor
- Abbott Medical Devices
Chronic Pain
Algovita Post-Market Clinical Study: Spinal Cord Stimulation to Treat Chronic Pain
The purpose of this study is to obtain real-world clinical outcome data for the Algovita Spinal Cord Stimulation system when used, on-label, according to the applicable directions for use.
- Trial name
- NCT02373540
- Testing
- Algovita Spinal Cord Stimulation system
- Where
- 18 sites in United States, Germany
- Volunteers
- 91 people
- Sponsor
- Nuvectra
Failed Back Surgery Syndrome
SubQStim: A Post-market Study of Subcutaneous Nerve Stimulation in Failed Back Surgery Syndrome (FBSS) Patients
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…
- Trial name
- NCT01711619
- Testing
- subcutaneous nerve stimulation, Optimized Medical Management
- Where
- 26 sites in Australia, Austria and 8 more
- Volunteers
- 162 people
- Sponsor
- MedtronicNeuro
Chronic Pain
Spinal Cord Stimulation for Low Back Pain
The purpose of this study is to assess the acute and chronic effectiveness of the Advanced Bionics Precision(TM) Spinal Cord Stimulation System in subjects with failed back surgery syndrome and associated low back axial pain.
- Trial name
- NCT00205868
- Testing
- Precision Spinal Cord Stimulation System
- Where
- 30 sites in United States
- Volunteers
- 304 people
- Sponsor
- Boston Scientific Corporation
Chronic Neuropathic Pain, Chronic Pain Management
Exploring Neurosphere's Remote Monitoring and Virtual Clinic Features in Improve Quality of Life and Reduce Costs
This study evaluates the effectiveness of Abbott's Proclaim™ and Eterna™ Spinal Cord Stimulator (SCS) systems, along with the Neurosphere™ virtual clinic platform, in managing chronic pain.
- Conditions
- Chronic Neuropathic Pain, Chronic Pain Management, Spinal Cord Stimulation (SCS), Pain Modulation
- Trial name
- TRC-AB-1 (NCT06647576)
- Testing
- Spinal Cord Stimulation - In Clinic, Spinal Cord Stimulation - Neurosphere
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Mahesh Pattabiraman