Clinical trials: FBSS
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
Failed Back Surgery Syndrome
Study Comparing Conventional, Burst and High Frequency (HF) Spinal Cord Stimulation (SCS) in Refractory Failed Back Surgery Syndrome (FBSS) Patients After a 32-contact Surgical Lead Implantation
Chronic Back and/or Leg Pain (CBLP) after spinal surgical procedures, a condition commonly labelled Failed Back Surgery Syndrome (FBSS), affects between 15% and 40% of patients after a spine surgery.
- Trial name
- MULTIWAVE (NCT03014583)
- Testing
- Precision Spectra™ system
- Where
- France
- Volunteers
- 28 people
- Sponsor
- Poitiers University Hospital
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
Pain, Chronic
Evaluation of the Effect of Caudal Epidural Pulsed Radiofrequency Stimulation on Chronic Pain
Postlumbar surgery syndrome (PLSS; failed back syndrome) is characterized by persistent pain in the lower back or lower extremities after spinal surgery. It occurs in 10-40% of patients who undergo a back surgery.
- Trial name
- NCT05062993
- Testing
- caudal epidural pulse radio frequency
- Where
- Turkey (Türkiye)
- Volunteers
- 30 people
- Sponsor
- Diskapi Teaching and Research Hospital
Postdiscectomy Epidural Fibrosis, Pain
Efficacy and Safety of Sodium Hyaluronate Gel Combined With Sodium Bicarbonate Versus Sodium Bicarbonate Alone in Prevention of Failed Back Surgery Syndrome
This study investigates the efficacy and safety of Sodium Hyaluronate gel combined with Sodium Bicarbonate compared to Sodium Bicarbonate alone in preventing Failed Back Surgery Syndrome (FBSS) and epidural fibrosis after lumbar…
- Trial name
- NCT06999993
- Testing
- Sodium hyaluronate jell, Sodium Bicarbonate, Saline
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Misr University for Science and Technology
Persistent Spinal Pain Syndrome Type 2, Failed Back Surgery Syndrome
Open and Closed Loop DTM SCS in Patients With PSPS Type 2: ENDLESS Study
Evaluation of the effectiveness of differential target multiplexed spinal cord stimulation for treatment of Persistent Spinal Pain Syndrome Type II (PSPS-T2).
- Conditions
- Persistent Spinal Pain Syndrome Type 2, Failed Back Surgery Syndrome, Failed Neck Surgery Syndrome
- Trial name
- ENDLESS (NCT07211308)
- Testing
- Spinal Cord Stimulation
- Where
- 5 sites in Belgium, Netherlands
- Volunteers
- 200 people
- Sponsor
- Universitair Ziekenhuis Brussel
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
Failed Back Surgery Syndrome, Degeneration Lumbar Spine
Restoring Segmental Lumbar Lordosis After Failed Previous Fusion at the Same Level
The restoration of lumbar lordosis is mandatory during lumbar fusion surgery for degenerative disc disease, since not restoring lumbar lordosis adequately may adversely affect surgical outcomes and the patient's quality of life…
- Conditions
- Failed Back Surgery Syndrome, Degeneration Lumbar Spine, Degenerative Spondylolisthesis, Sagittal Imbalance
- Trial name
- NCT07050290
- Testing
- Restoring segmental lordosis at the lumbar spine
- Where
- Russia
- Volunteers
- 20 people
- Sponsor
- N.N. Priorov National Medical Research Center of Traumatology and Orthopedics
Chronic Pain, Neuropathic Pain
Intraoperative Neuromonitoring Recording With a Novel SCS Paddle: Phase II
The purpose of this study is to demonstrate safety and efficacy of a new spinal cord stimulation paddle electrode which is able to target the dorsal horns, dorsal nerve roots, and dorsal columns.
- Conditions
- Chronic Pain, Neuropathic Pain, Failed Back Surgery Syndrome, Complex Regional Pain Syndromes
- Trial name
- NCT05459324
- Testing
- HD Study Electrode
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Albany Medical College
Failed Back Surgery Syndrome, Low Back Pain
Epidural Steroid Injections in Post-lumbar Surgery Syndrome After Single-level Discectomy
62 patients with postlumbar surgery syndrome were randomized and divided into two groups. Transforaminal epidural steroid injection (TFESI) was applied to the TFESI group (n=31), and caudal epidural steroid injection (CESI) was…
- Conditions
- Failed Back Surgery Syndrome, Low Back Pain, Radiculopathy, Epidural Fibrosis
- Trial name
- NCT05099796
- Testing
- Transforaminal epidural steroid injection, Caudal epidural steroid injection
- Where
- Turkey (Türkiye)
- Volunteers
- 62 people
- Sponsor
- Marmara University
Failed Back Surgery Syndrome, Lumbar Radiculopathy
EuroPainClinicsStudy IX ( EPCS IX )
This prospective investigator-initiated study compares the clinical effectiveness and safety of epiduroscopic adhesiolysis in patients with failed back surgery syndrome (FBSS) and in patients with lumbar radicular pain without…
- Conditions
- Failed Back Surgery Syndrome, Lumbar Radiculopathy, Chronic Low Back Pain, Epidural Fibrosis
- Trial name
- EPCS IX (NCT07411950)
- Testing
- Epiduroscopic mechanical adhesiolysis, Epidural pharmacologic therapy
- Where
- Slovakia
- Volunteers
- 141 people
- Sponsor
- EPC Education s.r.o.
Failed Back Surgery Syndrome, Spinal Stenosis
Value of Three-dimensional Rotational Epidurography on Percutaneous Epidural Adhesiolysis
Conventional epidurography (CE) is thought to have insufficient usefulness on percutaneous epidural adhesiolysis (PEA). The investigators aimed to evaluate the association between the outcome of PEA and three…
- Trial name
- NCT04216992
- Testing
- Cone beam computed tomography
- Where
- Taiwan
- Volunteers
- 30 people
- Sponsor
- Tri-Service General Hospital (TSGH)
Failed Back Surgery Syndrome
Effective Connectivity in Patients Receiving Spinal Cord Stimulation: an fMRI and EEG Dynamic Causal Modeling Study
In this study, a retrospective analysis will be performed on collected data of 14 patients with Failed Back Surgery Syndrome, treated with Spinal cord stimulation.
- Trial name
- CRIME (NCT03626428)
- Where
- Belgium
- Volunteers
- 14 people
- Sponsor
- Moens Maarten
Failed Back Surgery Syndrome
Effectiveness and Cost Management of Multicolumn Spinal Cord Stimulation in Neuropathic Pain Patients With Failed Back Surgery Syndrome
Failed back surgery syndrome (FBSS) constitutes a frequent pathology, generates a severe handicap for patients and represents a considerable expense for healthcare system.
- Trial name
- ESTIMET (NCT01628237)
- Testing
- comparison of spinal cord stimulation
- Where
- France
- Volunteers
- 115 people
- Sponsor
- Poitiers University Hospital
Chronic Low Back Pain, After Lumbar Spine Surgery
Efficacy of Cognitive Functional Therapy in Individuals With Chronic Low Back Pain After Spinal Surgery
Chronic low back pain after spinal surgery is a complex and disabling condition influenced by biopsychosocial factors. Cognitive Functional Therapy (CFT) is a promising intervention targeting these multidimensional aspects.
- Conditions
- Chronic Low Back Pain, After Lumbar Spine Surgery, Failed Back Surgery Syndrome (FBSS)
- Trial name
- NCT07576062
- Testing
- CFT
- Volunteers
- 90 people
- Sponsor
- Centro Universitário Augusto Motta
Failed Back Surgery Syndrome
StruCtuRal And FuncTional Brain Alterations by Conventional Spinal Cord Stimulation And High DensitY Stimulation
This study is an interventional prospective observatory single center trial, investigating the supraspinal effects of long term conventional SCS (60 Hz) and paresthesia-free high density SCS in failed back surgery syndrome (FBSS)…
- Trial name
- SCRATCHY (NCT02650349)
- Testing
- fMRI
- Where
- Belgium
- Volunteers
- 11 people
- Sponsor
- Universitair Ziekenhuis Brussel
Failed Back Surgery Syndrome, Persistent Spinal Pain Syndrome Type 2
Differential Target Multiplexed Spinal Cord Stimulation
Evaluation of the effectiveness of differential target multiplexed spinal cord stimulation for treatment of chronic back and leg pain.
- Trial name
- DETECT (NCT05068011)
- Testing
- Spinal Cord Stimulation
- Where
- 14 sites in Belgium
- Volunteers
- 250 people
- Sponsor
- Moens Maarten
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
Pain, Intractable
Identification of Outcome Predictors and Stratification of Responder Profiles Implanted With Spinal Cord Stimulation. An AI-based-pathway & Algorithmic Approach to Treat Failed Back Surgery Syndrome Patients
Failed Back Surgery Syndrome is commonly defined as new, recurrent, or persistent pain in the back and/or leg(s) of at least 6-month duration following spinal surgery.
- Trial name
- PREDIBACK 2 (NCT04587674)
- Testing
- Spinal Cord Stimulation
- Where
- 7 sites in France
- Volunteers
- 110 people
- Sponsor
- Poitiers University Hospital
Failed Back Surgery Syndrome
Low Level Laser Therapy to Reduce Comorbidity in Spinal Surgery
Each year, more than one million individuals worldwide are submitted to laminectomies, with a failure rate higher than 40%. Postlaminectomy epidural adhesion is implicated as a main cause of ''failed back surgery syndrome'' and…
- Trial name
- LASPINE (NCT02529657)
- Testing
- Low Level Laser Therapy
- Where
- Brazil
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- University of Nove de Julho