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
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
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
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, 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
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
Back Pain, Spinal Cord Stimulation
Efficacy of Spinal Cord Stimulation in Patients With a Failed Back Surgery Syndrome.
When patients suffer from chronic pain after multiple back surgeries, this is denominated as the 'failed back surgery syndrome'. A possible treatment for these patients is spinal cord stimulation.
- Trial name
- HDS (NCT03462147)
- Testing
- Spinal cord stimulation
- Where
- Belgium
- Volunteers
- 6 people
- Sponsor
- Ziekenhuis Oost-Limburg
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
Pain, Postoperative
Characteristics and Medical Resource Utilization of Postoperative Patients
The objective of this study is to assess and analyze the characteristics and usage of conventional and Korean medical services in postoperative patients.
- Trial name
- NCT03293212
- Where
- South Korea
- Volunteers
- 102 people
- Sponsor
- Jaseng Medical Foundation
Spinal Cord Stimulation, Failed Back Surgery Syndrome
Transcriptomic Profile of Patients Treated With Different Modalities of Spinal Cord Stimulation
Failed Back Surgery Syndrome (FBSS) is a relatively common condition that can cause a severe disability in patients. Spinal cord stimulation (SCS) is used in those patients refractory to conventional therapies.In this project the…
- Conditions
- Spinal Cord Stimulation, Failed Back Surgery Syndrome, Genetic Change
- Trial name
- SCS-OMICS (NCT05712980)
- Testing
- Implanted pulse generator for SCS with different programming modalities
- Where
- Spain
- Volunteers
- 40 people
- Sponsor
- Hospital General Universitario de Valencia
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
Laminectomy, Post-laminectomy Syndrome
Spinal Cord Stimulation in Patients With Post-Laminectomy Syndrome in Testing Phase
Traditionally, pain relief through spinal cord stimulation has been associated with the appearance of paresthesia in the affected area.
- Conditions
- Laminectomy, Post-laminectomy Syndrome, Spinal Cord Syndrome, Failed Back Surgery Syndrome
- Trial name
- NCT03702010
- Testing
- spinal cord stimulation conventional, spinal cord stimulation experimental
- Where
- 2 sites in Spain
- Volunteers
- 27 people
- Sponsor
- Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Post-laminectomy Pain Syndrome
GRASSP: Gralise® for Spine Surgery Pain
Evaluate the analgesic benefit of Gralise® for post-laminectomy pain syndrome (PLPS)
- Trial name
- GRASSP (NCT01764464)
- Testing
- Gralise®
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- University of Rochester
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 (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
Chronic Pain, Acute Pain
Assessing Symptom and Mood Dynamics in Pain Using the Smartphone Application SOMA
This study relies on the use of a smartphone application (SOMA) that the investigators developed for tracking daily mood, pain, and activity status in acute pain, chronic pain, and healthy controls over four months.The primary…
- Conditions
- Chronic Pain, Acute Pain, Post Operative Pain, Fibromyalgia, Primary
- Trial name
- NCT05754190
- Testing
- SOMA pain manager smartphone application
- Where
- United States
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- Brown University
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, Chronic Pain
Effects of Low Back Pain Types on Pain Severity and Quality of Life in Patients With Failed Back Surgery Syndrome
The aim of this study is to determine the effects of different types of low back pain on pain intensity and quality of life in patients with failed low back surgery syndrome.
- Trial name
- back pain (NCT07488936)
- Where
- Turkey (Türkiye)
- Volunteers
- 200 people
- Sponsor
- Konya Beyhekim Training and Research Hospital
Spinal Fusion, Radiculopathy Lumbar
SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study
The purpose of the study is to evaluate the safety and tolerability of DRG stimulation when placing a neurostimulator during the same procedure as implantation of spinal fixation with or without interbody cage systems in patients…
- Conditions
- Spinal Fusion, Radiculopathy Lumbar, Chronic Pain
- Trial name
- NCT04054401
- Testing
- DRG Neurostimulation with Spinal Fusion
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- SynerFuse, Inc
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