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Failed Back Surgery Syndrome clinical trials

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NCT ID: NCT04655833 Completed - Clinical trials for Medicine, Korean Traditional

Integrative Korean Medicine Treatment for Inpatients With Failed Back Surgery Syndrome: A Retrospective Study With Survey

Start date: October 22, 2020
Phase:
Study type: Observational

The purpose of this study is to reveal the effectiveness and safety of integrative Korean medicine for Failed Back Surgery Syndrome(FBSS) by observing inpatients treated with integrative Korean medicine. This study is a retrospective observational study. The subjects for study are patients diagnosed with FBSS and who have been admitted to four Jaseng Hospital of Korean medicine (Gangnam, Bucheon, Daejeon, and Haeundae) for 2015.01.01-2019.12.31. Medical records of selected patients will be analyzed, and telephone surveys will be conducted for each patient. The survey questions are Numeric ratinc scale (NRS), Oswestry Disability Index(ODI), quality of life, and Patient Global Impression of Change (PGIC), etc.

NCT ID: NCT04587674 Recruiting - Pain, Intractable Clinical Trials

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

PREDIBACK 2
Start date: April 19, 2021
Phase: N/A
Study type: Interventional

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. The literature estimates that 10-50% of patients undergoing spinal surgery are likely to develop such pain, representing a substantial financial burden. Among them, 5-10% would suffer from severe pain, which are intense, neuropathic and generally refractory to conventional therapeutic strategies considerably affect patients' functional capacity as well as their psychological and social well-being. Spinal Cord Stimulation (SCS) is a well-established therapy to alleviate severe intractable neuropathic pain such as FBSS. SCS is a safe and reversible treatment option, which leads to improvement in pain relief and quality of life for patients with FBSS. Despite encouraging results in a chronic painful patient population that is refractory to conventional therapies, the literature estimates that only 58% [53% - 64%] of patients implanted with SCS devices achieved adequate pain relief. FBSS population characterization and stratification and predictive modeling of SCS outcome are thus crucial to delineate future treatment options and to deliver neuromodulation therapy to the right patient. The investigators designed a clinical prospective project based on SCS outcome optimization and SCS candidates' stratification: PREDIBACK 2. This study would be a following part of a continuous project (PREDIBACK) that aims to better understand and stratify the therapies (drugs, surgery, psychological therapy or SCS) proposed to FBSS patients. The goal of PREDIBACK 1 was to develop a decision tool that simplifies the therapeutic decision process. PREDIBACK 2 will focus on the neuromodulation pathway. Easing and helping patient orientation should improve referral yielding to specialists and accelerate patient flow through care pathway. Hence, facilitating access to adequate therapies for FBSS patients who usually have a longstanding history of pain.

NCT ID: NCT04500691 Completed - Clinical trials for Failed Back Surgery Syndrome

pRedicting the Long-term rEsponse of High Frequency sPinal cOrd sTimulation in Patients With Failed Back Surgery Syndrome.

REPORT
Start date: June 15, 2020
Phase:
Study type: Observational

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.

NCT ID: NCT04469738 Completed - Clinical trials for Failed Back Surgery Syndrome

Evaluating a Treatment Effect in Patients With FBSS Using an Electronic Nose: a Pilot Study

NOSE
Start date: December 12, 2020
Phase: N/A
Study type: Interventional

This study is an experimental single-center pilot study investigating Volatile Organic Compounds patterns in exhaled breath during on and off states of SCS, in patient with Failed Back Surgery Syndrome.

NCT ID: NCT04268602 Not yet recruiting - Pain, Chronic Clinical Trials

The Effect of Intradermal Local Anesthetic Injection in FBSS (Failed Back Surgery Syndrome)

FBSS
Start date: September 1, 2020
Phase: N/A
Study type: Interventional

Failed Back Surgery Syndrome is described as chronic pain in the low back and/or legs after a spinal procedure. It is estimated that %10 - 40 of the patients who had spinal surgery will have Failed Back Surgery Syndrome. The aim of this study is to research whether intradermal injection of the local anesthetic on the operation scar area and the area in which pain referred to in patients with Failed Back Surgery Syndrome has effects on pain and functionality or not.

NCT ID: NCT04244669 Recruiting - Clinical trials for Failed Back Surgery Syndrome

Impact of the SCS With Different Waveforms Over the Quality of Life (SCS-Quality)

SCS-Quality
Start date: November 26, 2020
Phase: N/A
Study type: Interventional

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 Surgery Syndrome (FBSS). The study has been designed to assess primarily non-inferiority and secondarily superiority of SCS DTM therapy

NCT ID: NCT04216992 Completed - Spinal Stenosis Clinical Trials

Value of Three-dimensional Rotational Epidurography on Percutaneous Epidural Adhesiolysis

Start date: January 4, 2018
Phase:
Study type: Observational

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 dimensional-rotational epidurography (3D-RE). The investigators performed 30 PEA in 26 patients, and evaluated their post-PEA image findings. Two independent clinicians categorized and recorded the occurrence of contrast at intra-canal ventral and extra-foraminal regions on CE; and contrast at dorsal canal (DC), ventral canal (VC), dorsal foramen (DF), and ventral foramen (VF) on 3D-RE. Reproducibility was assessed using intra-class correlation coefficients (ICCs). The symptom relief after one month for the patients receiving PEA and the contrast distribution patterns of CE and 3D-RE and were determined.

NCT ID: NCT04121104 Completed - Clinical trials for Failed Back Surgery Syndrome

Electrodermal Activity and Respiration in Patients Treated With Spinal Cord Stimulation

Start date: October 8, 2019
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04003714 Completed - Clinical trials for Failed Back Surgery Syndrome

REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION FOR FAILED BACK SURGERY SYNDROME

Start date: May 1, 2014
Phase: N/A
Study type: Interventional

Failed back surgery syndrome (FBSS) is the term of persistent back and/or leg pain after surgery for lumbar disk herniation (LDH). Repetitive transcranial magnetic stimulation (r-TMS) is a technique that allows non-invasive and relatively painless stimulation of cerebral cortex. It can reduce the experience of chronic pain by using magnetic field to produce small electrical currents in the cortex.The aim of this study is to determine the effectiveness of r-TMS treatment on patients with FBSS.

NCT ID: NCT03957395 Recruiting - Clinical trials for Failed Back Surgery Syndrome

Comparison of Effectiveness of Tonic, High Frequency and Burst Spinal Cord Stimulation in Chronic Pain Syndromes

Start date: September 1, 2018
Phase: N/A
Study type: Interventional

Spinal cord stimulation (SCS) is one of the most commonly undertaken neuromodulatory surgery techniques in the treatment of neuropathic pain. The indication for SCS is an ineffective conservative treatment of chronic pain syndromes. The effectiveness of SCS in the case of neuropathic pain is high. The positive result of SCS treatment is the reduction of previous painful symptoms by min. 50% and / or a reduction in the amount of taken analgesics and an improvement in the quality of life including sleep quality. Long-term studies estimate that in a properly selected group of patients more than 50% of patients achieve pain reduction by the required 50% and about 60% - 70% have an improvement in the quality of life and a reduction of pain. The efficacy of SCS in different modes of stimulation is evaluated. Patients receive four different types of stimulation for 2-week period - not knowing what kind of stimulation it is. It is said that in one type of stimulation they would feel parestesias and in other three they would not. Patients are not informed that beside tonic, burst and high frequency stimulation, the fourth is an off stimulation to check for placebo effect. The test is double-blinded