Clinical trials: FBSS
Failed Back Surgery Syndrome
A Novel Approach in Spinal Cord Stimulation: a Combination of Burst and Tonic Waveforms.
Spinal Cord Stimulation (SCS) has been a well-established treatment for chronic neuropathic pain in Failed Back Surgery Syndrome with associated legs and/or low back pain.
- Trial name
- NCT03201705
- Testing
- Burst + Tonic
- Volunteers
- 10 people
- Sponsor
- Massimo Innamorato
Failed Back Surgery Syndrome, Chronic Pain
Patient Profiling and Outcome Assessment in Spinal Cord Stimulation for Chronic Back and/or Leg Pain
The PROSTIM study is an ongoing prospective, multicentric and observational clinical study. Patients are recruited in three different centers in Eastern Belgium from May 2018 onwards.
- Trial name
- PROSTIM (NCT05349695)
- Testing
- Spinal cord stimulation
- Where
- 3 sites in Belgium
- Volunteers
- 200 people
- Sponsor
- Studie- & Opleidingscentrum Neurochirurgie Virga Jesse
Failed Back Surgery Syndrome
Improvement of Gait by Spinal Stimulation in Patients With Postoperative Chronic Lumbosciatalgia: Pilot Study (GaitStim)
The purpose of this study is to explore the changes in objective walking parameters induced by medullary stimulation in patients with Fail Back Surgery Syndrome, after chronic stimulation, in comparison with preoperative…
- Trial name
- GAITSTIM (NCT05857696)
- Testing
- walking quantified analysis
- Where
- France
- Volunteers
- 36 people
- Sponsor
- Centre Hospitalier Universitaire de Nice
Pain, Neuropathic, Failed Back Surgery Syndrome
Coordinated Reset Spinal Cord Stimulation
The goal of this study is to evaluate whether a new spinal cord stimulation paradigm, called Coordinate Reset (CR) Stimulation, can provide equivalent or better pain relief with reduced energy requirements.
- Trial name
- NCT04997278
- Testing
- Coordinated Reset spinal cord stimulation
- Where
- United States
- Sponsor
- Stanford University
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
Persistent Spinal Pain Syndrome Type II, Failed Back Surgery Syndrome
Persistent Post-Lumbar Surgery Pain Syndrome (PSPS) Type II is a Common Condition Encountered in Pain Units, With Limited Available Therapeutic Options. Epidural Pulsed Radiofrequency (PRF) Administered Via Catheter Has Demonstrated Greater Efficacy Compared to the Transforaminal Approach. This Rand
This study is for people who continue to have low back pain after spinal surgery, a condition called persistent spinal pain syndrome type II. Current treatments, such as epidural injections, often provide only limited relief.
- Conditions
- Persistent Spinal Pain Syndrome Type II, Failed Back Surgery Syndrome, Chronic Low Back Pain, Post-Laminectomy Syndrome
- Trial name
- EPIPUL (NCT07156513)
- Testing
- Epidural Pulsed Radiofrequency, Betamethasone (Epidural Corticosteroid Injection)
- Where
- 4 sites in Spain
- Volunteers
- 131 people
- Sponsor
- Puerta de Hierro University Hospital
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
Failed Back Surgery Syndrome
Evaluation of the Brain Activity During Spinal Cord Stimulation in Failed Back Surgery Syndrome Using Functional MRI and MRS
Functional Magnetic Resonance Imaging (fMRI)and MR Spectroscopy of the brain are perfect tools to investigate the changes in the brainstem and brain evoked by the orthodromically impulses of a SCS.
- Trial name
- NCT01181817
- Testing
- fMRI and MRS
- Where
- Belgium
- Volunteers
- 40 people
- Sponsor
- Universitair Ziekenhuis Brussel
Failed Back Surgery Syndrome, Spinal Cord Stimulation
Return to Work for Persistent Spinal Pain Syndrome Type II Patients
A multicenter randomized controlled trial will be conducted to evaluate whether the ability to work in Persistent Spinal Pain Syndrome Type II (PSPS-T2) patients after SCS implantation is different after a personalized…
- Trial name
- OPERA (NCT05269212)
- Testing
- Usual Care trajectory, A biopsychosocial rehabilitation program
- Where
- 5 sites in Belgium
- Volunteers
- 112 people
- Sponsor
- Moens Maarten
Failed Back Surgery Syndrome (FBSS)
Caudal Epidural With or Without Lumbar Sympathetic Block for Redo Lumbar Surgery
Comparing the analgesic effect of caudal epidural versus combined lumbar sympathetic block with caudal epidural in patients undergoing redo spinal surgery.
- Trial name
- CLEARS (NCT07199816)
- Testing
- Fluoroscopy-Guided Caudal Epidural Block, Combined Lumbar Sympathetic Ganglion Block and Caudal Epidural Block
- Where
- Egypt
- Volunteers
- 64 people
- Sponsor
- Hebatullah Mohammed Abdelmageed
Failed Back Surgery Syndrome
Effectiveness and Safety of Percutaneous Adhesiolysis Using Rac'z Catheter Versus Navi Catheter in Management of Failed Back Surgery Syndrome
In the past decade, spine surgery rates have dramatically increased in parallel to those of other procedural interventions. Persistent pain is a common occurrence after spine surgery, with the most commonly quoted prevalence…
- Trial name
- NCT05018377
- Testing
- Racz adhesolysis, NAVI adhesolysis
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Assiut University
Chronic Pain, Complex Regional Pain Syndrome
Effects of Spinal Cord Stimulation on Sensory Perceptions of Chronic Pain Patients
It's well known that Spinal cord stimulation (SCS) changes the perception of chronic pain in the area stimulated by epidural electrodes.
- Conditions
- Chronic Pain, Complex Regional Pain Syndrome, Failed Back Surgery Syndrome
- Trial name
- NCT02837822
- Testing
- Spinal cord stimulator, Implantation of a spinal cord stimulator
- Where
- 2 sites in United States, Canada
- Volunteers
- 38 people
- Sponsor
- CHU de Quebec-Universite Laval
Failed Back Surgery Syndrome (FBSS), Persistent Spinal Pain Syndrome Type 2 (PSPS-T) Lower Spine
Evaluation of Medication Tapering on the Sensitivity of the Spinal Cord Using Closed-Loop Spinal Cord Stimulation (Pilot Study)
This pilot study investigates the effects of reducing pain medication including opioids and anticonvulsants, on spinal cord sensitivity during closed-loop spinal cord stimulation (SCS).
- Conditions
- Failed Back Surgery Syndrome (FBSS), Persistent Spinal Pain Syndrome Type 2 (PSPS-T) Lower Spine, Neurophysiological Sensitivity to Spinal Cord Stimulation
- Trial name
- ECAP-MED Pilot (NCT07502612)
- Testing
- Spinal Cord Stimulation with Evoke Closed-Loop System
- Where
- Belgium
- Volunteers
- 20 people
- Sponsor
- Brai²n
Failed Back Surgery Syndrome
HRV in Patients Treated With Spinal Cord Stimulation
This study is an observatory single center study investigating heart rate variability during on and off states of the spinal cord stimulator, in patients with failed back surgery syndrome.
- Trial name
- NCT03768791
- Testing
- SCS is switched off, SCS is switched on
- Where
- Belgium
- Volunteers
- 23 people
- Sponsor
- Moens Maarten
Failed Back Surgery Syndrome
Clinical Evaluation of Direct Dorsal Column Stimulation
The study will examine the feasibility of Direct Dorsal Column Stimulation using existing Stimulation Leads (Ad-Tech). Secondary endpoints will include pain relief, somatosensory evoked potentials (SSEPs), stimulator settings…
- Trial name
- DDCS (NCT02020460)
- Testing
- Subdural trial lead, Epidural trial lead
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Duke University
Failed Back Surgery Syndrome, CRPS (Complex Regional Pain Syndromes)
Comparison of Effectiveness of Tonic, High Frequency and Burst Spinal Cord Stimulation in Chronic Pain Syndromes
Spinal cord stimulation (SCS) is one of the most commonly undertaken neuromodulatory surgery techniques in the treatment of neuropathic pain.
- Trial name
- NCT03957395
- Testing
- Device: Precision Novi™ system Neurostimulation procedures
- Where
- Poland
- Volunteers
- 50 people
- Sponsor
- Jan Biziel University Hospital No 2 in Bydgoszcz
Back Pain, Failed Back Surgery Syndrome
Epidural Pulsed Radiofrequency Treatment in Failed Back Surgery Syndrome
Low back pain can persist in some patients with history of back surgery. In some cases, an increase in pain may even occur, and chronic pain may make treatment more difficult.
- Conditions
- Back Pain, Failed Back Surgery Syndrome, Neuropathic Pain
- Trial name
- NCT06239857
- Testing
- Epidural pulsed radiofrequency
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Başakşehir Çam & Sakura City Hospital
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.
Chronic Intractable Pain
The True Efficacy of Burst Spinal Cord Stimulation in the Management of Intractable Low Back Pain (TRU-BURST)
The purpose of this prospective, multi-center, randomized, triple-blind, sham-controlled study with parallel economic evaluation is to test the analgesic superiority of BurstDR-SCS compared to sham stimulation using both…
- Trial name
- NCT06030284
- Testing
- BurstDR-SCS
- Where
- 5 sites in Canada, United Kingdom
- Sponsor
- Abbott Medical Devices
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