Clinical trials: Failed Back Surgery Syndrome
Failed Back Surgery Syndrome
Value of Target-controlled Intravenous Anaesthesia (TCIVA) in Spinal Cord Stimulation
Study design 60 patients Monocenter prospective study Randomized in 2 groups 36 months Objectives Demonstrate the superiority of target controlled intravenous anesthesia versus total anesthesia with the low back paresthesia…
- Trial name
- AIVOC (NCT02821897)
- Testing
- Target-controlled intravenous anaesthesia, Total anaesthesia
- Where
- France
- Volunteers
- 15 people
- Sponsor
- Poitiers University Hospital
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, Spinal Cord Stimulation
Impact of the SCS With Different Waveforms Over the Quality of Life (SCS-Quality)
Prospective, randomized, multicentre, parallel, controlled, and double-blind trial. It is a study with 2 groups with evaluation pre and post treatment with Spinal Cord Stimulation (SCS) implantation of patients with Failed Back…
- Trial name
- SCS-Quality (NCT04244669)
- Testing
- IPG with Conventional Stimulation, IPG with SCS DTM
- Where
- Spain
- Volunteers
- 120 people
- Sponsor
- Pablo López Pais
Neuropathic Pain, Complex Regional Pain Syndromes (CRPS)
Sub-threshold DRG Stimulation vs Sham in Established Responders
The goal of this clinical trial is to learn if sub-threshold dorsal root ganglion (DRG) stimulation provides pain relief beyond placebo in adults with chronic neuropathic pain who already have an implanted DRG stimulator.
- Conditions
- Neuropathic Pain, Complex Regional Pain Syndromes (CRPS), Causalgia, Chronic Pain
- Trial name
- DRG-SHAM (NCT07170722)
- Testing
- Subtreshhold DRG-S
- Where
- Sweden
- Volunteers
- 20 people
- Sponsor
- Umeå University
Failed Back Surgery Syndrome
REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION FOR FAILED BACK SURGERY SYNDROME
Failed back surgery syndrome (FBSS) is the term of persistent back and/or leg pain after surgery for lumbar disk herniation (LDH).
- Trial name
- NCT04003714
- Testing
- Repetitive Transcranial Magnetic Stimulation
- Volunteers
- 20 people
- Sponsor
- Fatih Sultan Mehmet Training and Research Hospital
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
Electrodermal Activity and Respiration in Patients Treated With Spinal Cord Stimulation
This study is investigating skin conductance and respiration during on and off states of the spinal cord stimulator, in patients with failed back surgery syndrome.
- Trial name
- NCT04121104
- Testing
- SCS is switched off, SCS is switched on
- Where
- 2 sites in Belgium
- Volunteers
- 28 people
- Sponsor
- Moens Maarten
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
Failed Back Surgery Syndrome
EEG Mapping During High Frequency/High Density Spinal Cord Stimulation in Patients With Failed Back Surgery Syndrome
This study is an interventional, observatory single center trial investigating the functional connectivity of the electrical brain activity in high frequency/high density spinal cord stimulation in failed back surgery syndrome…
- Trial name
- EEGInspiration (NCT02751216)
- Testing
- EEG recording + pain protocol
- Where
- Belgium
- Volunteers
- 20 people
- Sponsor
- Moens Maarten
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
Persistent Spinal Pain Syndrome Type 2, Failed Back Surgery Syndrome
Effects of Active Versus Passive Recharge Burst Spinal Cord Stimulation on Pain Experience in Persistent Spinal Pain Syndrome Type 2: a Multicenter Randomized Trial (BURST-RAP Study)
Spinal cord stimulation (SCS) has shown to be an effective treatment for patients with persistent spinal pain syndrome Type 2 (PSPS Type 2). The method used to deliver electrical charge in SCS is important.
- Trial name
- BURST-RAP (NCT05421273)
- Testing
- Spinal cord stimulation using passive recharge burst stimulation, Spinal cord stimulation using active recharge burst stimulation
- Where
- 6 sites in Netherlands
- Volunteers
- 96 people
- Sponsor
- Rijnstate Hospital
Failed Back Surgery Syndrome
pRedicting the Long-term rEsponse of High Frequency sPinal cOrd sTimulation in Patients With Failed Back Surgery Syndrome.
The aim of the current retrospective study is to predict responders for HF10-SCS therapy by only using baseline data. Data collected through clinical practice until June 2020 will be used in this retrospective analysis.
- Trial name
- REPORT (NCT04500691)
- Testing
- pain intensity reporting
- Where
- 2 sites in Belgium
- Volunteers
- 122 people
- Sponsor
- Moens Maarten
Failed Back Surgery Syndrome
Sweat Gland Function in Patients With Failed Back Surgery Syndrome, Treated With Spinal Cord Stimulation
This study is investigating sweat gland function during on and off states of the spinal cord stimulator, in patients with failed back surgery syndrome.
- Trial name
- NCT04668482
- Testing
- SCS is switched off, SCS is switched on
- Where
- Belgium
- Volunteers
- 23 people
- Sponsor
- Universitair Ziekenhuis Brussel
Herniated Disc, Failed Back Surgery Syndrome
The Effect of Central Sensitization in Radicular Pain in Patients With Failed Low Back Surgery Syndrome
The Effect of Central Sensitization in Radicular Pain in Patients with Failed Low Back Surgery Syndrome on Treatment Success of Ultrasound-Guided Caudal Epidural Steroid Injection
- Trial name
- NCT06508918
- Testing
- Betametasona
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 1 people
- Sponsor
- Marmara University
Pain, Chronic, Pain, Neuropathic
Caregiver Burden and Correlation With Clinical Outcome in Spinal Cord Stimulation for Chronic Neuropathic Pain
Prospective multicentric observational trial on caregiver burden, caregiver satisfaction and clinical outcome in spinal cord stimulation for chronic neuropathic pain.
- Conditions
- Pain, Chronic, Pain, Neuropathic, Failed Back Surgery Syndrome
- Trial name
- CAREstim (NCT04737746)
- Where
- 2 sites in Belgium
- Volunteers
- 42 people
- Sponsor
- AZ Delta
Failed Back Surgery Syndrome
Objective Data on Daily Activity in Patients Treated with SCS: the Intellis Study
In spinal cord stimulation (SCS), most outcome data are based on patient questionnaires. The lack of tools for objective evaluation of the effects of SCS on chronic pain has posed a barrier for providing solid proof of the…
- Trial name
- NCT04710355
- Testing
- Spinal cord stimulation
- Where
- 7 sites in Belgium, Denmark and 2 more
- Volunteers
- 50 people
- Sponsor
- Sahlgrenska University Hospital
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
Pain, Chronic, Failed Back Surgery Syndrome
Burst Spinal Cord Stimulation (Burst-SCS) Study
Recently a new form of spinal cord stimulation therapy called burst spinal cord stimulation (Burst-SCS) is available to treat chronic pain. The goal of this study is to learn more about how Burst-SCS works to reduce chronic pain.
- Trial name
- NCT03718325
- Testing
- Burst-SCS
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of Michigan
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
Subcutaneous Peripheral Nerve Stimulation (PNS) as "Hybrid Stimulation" After Failure of Spinal Cord Stimulation (SCS) to Control the Back Pain Component in Failed Back Surgery Syndrome (FBSS) Patients.(CUMPNS Study)
Despite globally favourable outcomes of Spinal Cord Stimulation (SCS), a significant proportion of Failed Back Surgery Syndrome (FBSS) patients do not obtain adequate coverage of low back pain.
- Trial name
- NCT02110888
- Testing
- Subcutaneous peripheral nerve stimulation, SCS Only
- Where
- France
- Volunteers
- 14 people
- Sponsor
- Poitiers University Hospital