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Spinal Stenosis clinical trials

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NCT ID: NCT04566874 Recruiting - Clinical trials for Degenerative Disc Disease

SPIRA™-A 3D and HCT/p DBM vs. Medtronic Divergent™-L/Perimeter™ and Recombinant BMP-2

Start date: July 13, 2020
Phase: N/A
Study type: Interventional

A prospective, randomized, controlled clinical evaluation utilizing the SPIRA™ ALIF 3-D printed titanium interbody device with DBM vs a Medtronic PEEK ALIF interbody device with BMP

NCT ID: NCT04552145 Recruiting - Spinal Stenosis Clinical Trials

Physical Therapy vs Surgical Decompression for Lumbar Spinal Stenosis

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

This is a randomized controlled multicenter trail comparing physical therapy to surgical decompression in patients with lumbar spinal stenosis. The 0-hypothesis is that there is no difference in the efficacy of structured physical therapy compared to surgical decompression. Our aim is to evaluate if physical therapy can serve as a nonsurgical alternative for patients with LSS, where the severity of symptoms indicates the need of surgical decompression.

NCT ID: NCT04540068 Recruiting - Clinical trials for Lumbar Spinal Stenosis

Prediction of TEI Success in Sciatica

POTEISS
Start date: November 15, 2020
Phase:
Study type: Observational

Rationale: Treatment with transforaminal epidural injections is part of usual care in patients suffering from lumbar radiculopathy. However, not all patients experience a satisfactory result from this treatment and it is unclear what percentage of patients responds well and if any clinical or radiological factors exist that predict a positive response. Objectives: Primary: to develop a model based on demographic, clinical and radiological parameters for prediction of treatment success after TEI Secondary: to estimate the short-term efficacy of TEI in patients with LDH and spinal stenosis based on pain, functionality and perceived recovery scores, to determine the correlation between clinical and radiological baseline parameters and physical and psychological patient outcome measures, to determine the rate of additional injections and rate of surgery after treatment with TEI, to determine the short-term (cost)effectiveness of TEI on physical and psychological patient outcome measures, and to determine the rate of complications associated with TEI Study design: Prospective cohort study Study population: Patients that are scheduled for TEI as part of usual care suffering from a new episode of lumbar radiculopathy Main study parameters/endpoints: leg and back pain scores at baseline, 30 minutes, 2 and 6 weeks after treatment. ODI, HADS, Quality of Life and PCI at baseline, 2 and 6 weeks after treatment. Perceived recovery at 2 and 6 weeks after treatment. Usage of healthcare at baseline, 2 and 6 weeks after treatment.

NCT ID: NCT04537026 Recruiting - Clinical trials for Lumbar Spinal Stenosis

Sterile Amniotic Fluid Filtrate Epidural Injection.

Start date: June 16, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

There is a large population of patients with lumbosacral radicular pain due to spinal stenosis who do not respond to physical therapy or oral medication management, yet wish to avoid spinal surgery or are simply not candidates due to medical co-morbidity. Given the natural history of lumbar spinal stenosis, these patients typically suffer from chronic pain and disability. Currently, the typical treatment for this population is serial corticosteroid injection. The efficacy of the treatment specifically for the indication of spinal stenosis is in question and is associated with both concerning chronic sequelae and the risk, although low, of catastrophic neurologic compromise. Alternatively, hAF is a promising new biologic treatment with neuro-protective and regenerative properties. Early studies demonstrate its anti-inflammatory properties, with high levels of anti-inflammatory cytokines, in addition to its ability to assist with regeneration of peripheral nerves. Furthermore, it has a favorable side-effect profile without concern for long-term sequelae or potential for neurologic compromise. The present study aims to determine if epidural injection of hAF compared to the corticosteroid dexamethasone is more effective for the treatment of lumbosacral radicular pain due to spinal stenosis, as measured by pain, disability, psychological function, oral analgesic use, and avoidance of surgery. Evidence for superiority of epidural hAF compared to dexamethasone injection would change the treatment paradigm for refractory radicular pain due to spinal stenosis. Furthermore, even if shown to be non-inferior to epidural dexamethasone, epidural hAF would be favored given its superior safety profile. Thus, this research has the potential to improve outcomes and patient safety in a very large population with chronic pain.

NCT ID: NCT04469387 Recruiting - Clinical trials for Degenerative Disc Disease

Preventive Effect of Limited Decompression on Adjacent Segment Following Posterior Lumbar Interbody Fusion

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

This is a prospective single-center study. Patients requiring posterior lumbar interbody fusion (PLIF) for degenerative disease are prospectively enrolled and followed. Patients enrolled in this study have asymptomatic pre-existing spinal canal stenosis at adjacent segment. This study will focus on the effects of preventative limited decompression at adjacent segment.

NCT ID: NCT04467944 Recruiting - Clinical trials for Degenerative Disc Disease

Effect of Pre-existing Adjacent Segment Degeneration on Long-term Effectiveness After Lumbar Fusion Surgery

Start date: January 1, 2018
Phase:
Study type: Observational

This is a prospective single-center study. Patients requiring posterior lumbar interbody fusion (PLIF) for lumbar degenerative disease are prospectively enrolled and followed. Important adjacent pre-existing degeneration factors include discs degenerated, facets and ligamentum flavum tropism which could lead to spinal canal stenosis (SCS). This study will focus on the effects of pre- existing adjacent degeneration (disc factors and spinal canal stenosis factors) on long-term postoperative outcomes.

NCT ID: NCT04407338 Recruiting - Clinical trials for Degenerative Lumbar Spinal Stenosis

Efficacy and Tolerance Study of B-DYN Versus Conventional Fusion in the Treatment of Lumbar Stenosis on the Degree of Post-operative Functional Incapacity (BDYNCLIN)

BDYNCLIN
Start date: June 1, 2020
Phase: N/A
Study type: Interventional

Degenerative Lumbar Spinal Stenosis (LSS) is an extremely common condition affecting more than 102 million people each year. It is a narrowing of the spinal canal in the lower back. It causes pain and even disorders of the lower limbs. When the symptoms get worse and the individual feels functional discomfort despite medical treatment, surgical intervention is recommended. Two surgical options are available: Rigid Stabilization Devices as conventional fusion with or without cage, or dynamic stabilization system as B-DYN device, this system is called "dynamic" because it allows the stabilization of the operated part while preserving a certain mobility. The main objective of this study is to evaluate the efficacy and tolerance of B-Dyn versus conventional bolted fusion (with or without cage) in the treatment of degenerative lumbar stenosis (DLS) on the degree of postoperative functional incapacity. So the investigator's hypothesis is that the use of the B-DYN device in the treatment of DLS could lead to the maintenance of functional disability related to low back pain (maintenance of walking and mobility). Another important point to be demonstrated in this study is the preservation of the mobility of the stage overlying the assembly performed by B-Dyn. Indeed, the continued degeneration of segments adjacent to lumbar vertebral fusions is a concern for surgeons For B-Dyn, which is a dynamic stabilization, the combination of rigid and flexible parts allows the mobility of the overlying stage to be preserved and could also lead to a decrease in adjacent syndrome in the long-term compared to the use of conventional fusion. The duration of patient follow-up is 60 months. The inclusion period is 24 months to recruit the necessary number of subjects for the study (a total of 216 patients is expected).

NCT ID: NCT04403360 Recruiting - Clinical trials for Lumbar Spinal Stenosis

Erector Spinae Plane Block After Lumbar Spinal Stenosis Surgery

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

Lumbar spinae stenosis surgery is a frequent intervention resulting in important postoperative pain. Management of this postoperative pain is thus important. Different pain management therapies exist. The erector spinae plane (ESP) block was described in 2016. It involves the injection of local anesthetics into the interfascial plane, deep to erector spinae muscle, allowing the blockade of the dorsal and ventral rami of the thoracic spinal nerves. It was initially proposed for analgesia of costal fractures, pulmonary lobectomy and thoracic vertebrae. The ESP block (ESPB) could probably be extended to a large number of surgical procedures. ESPB has so far not been investigated in lumbar spinae stenosis surgery.

NCT ID: NCT04401735 Recruiting - Clinical trials for Spinal Stenosis Lumbar

Effects and Safety of Epidural PDRN vs. Placebo

Start date: November 1, 2019
Phase: Phase 4
Study type: Interventional

This is a single-center, randomized, double-blind clinical study to assess the clinical application and outcomes with epidural PDRN versus Normal saline injection in patients with spinal stenosis.

NCT ID: NCT04273828 Recruiting - Back Pain Clinical Trials

Impact of Muscle Degeneration in Chronic Low Back Pain

Start date: April 6, 2020
Phase:
Study type: Observational

Surgical interventions for the removal of intervertebral disc fragments or to enlarge a narrow spine canal are commonly performed worldwide and are considered efficient. Concomitant low back pain is not uncommon among patients with lumbar nerve compression and neurological symptoms. When present, controversy persists in the literature regarding its ideal management. Although neurological symptoms improve after decompressive surgery, the presence of residual chronic low back pain may worsen satisfaction scores and cause functional disability. The hypothesis of the present study is that the presence of atrophy of the paraspinal and trunk muscles predicts chronic low back pain after lumbar neural decompression. If confirmed, this finding will aid in better planning of physical rehabilitation strategies for this group of patients, as well as a clearer prediction regarding surgical treatment outcomes for patients and health professionals.