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14 active trials for Lumbar Radiculopathy

Clinical Outcomes Associated With the Use of ViviGen® for the Treatment of Lumbar Degenerative Disc Disease

The objective of this study is to perform a prospective, randomized, controlled clinical trial to compare radiographic fusion rates and patient reported outcomes, including pain and function preoperatively and postoperatively, using Depuy ViviGen® Cellular Bone Matrix mixed with cortical/cancellous allograft in conjunction with an approved Depuy Synthes pedicle screw system compared to autograft mixed with cortical/cancellous allograft in conjunction with the same DePuy Synthes pedicle screw system used for a one or two - level posterolateral lumbar fusion.

Start: October 2018

Virtual Reality as a Substitute for Procedural Sedation During Epidural Steroid Injections

This study examines the impact of virtual reality compared to sedation (midazolam and/or fentanyl) and no intervention on pain experienced from an epidural steroid injection (ESI). The intervention group (who receive virtual reality as a distraction modality) is compared to a sedation group and a control group.

Start: August 2021

Predictive Factors for LBP Interventional Treatment Outcomes

In this study, we are attempting to determine which factors are associated with interventional treatment outcome for LBP (and to what extent). Up to 346 patients with LBP who are considered to be good candidates for therapeutic interventional procedures will be given a complete history and physical exam, which includes the assessment of Waddell signs, and querying them regarding factors shown in non-interventional studies or retrospective studies evaluating interventional treatments to be associated with negative treatment outcomes. These factors include the presence of Waddell and other physical exam signs, opioid use, allergies, psychopathology, concomitant pain conditions, a 6-point Likert scale on expectations, sleep abnormalities, secondary gain (e.g. medical board or litigation), procedure-related pain including from a 1 ml standardized injection, obesity, and smoking history. They will then proceed to undergo their scheduled intervention, which will be limited to epidural steroid injections (ESI), facet blocks and if positive, radiofrequency denervation, and sacroiliac (SI) joint injections. A positive outcome will be defined as 2-point or greater decrease in average pain score at 1-month and a score of > 3 on a 1-5 Likert satisfaction scale. Those with a positive outcome at 1-month will remain in the study and be followed again at 3-months.

Start: December 2014

Radiocontrast Media in the Pulsed Radiofrequency Treatment

Pulsed radiofrequency applied to the dorsal root ganglion (DRG) is an interventional treatment alternative in the treatment of lumbar radicular pain that does not respond to conservative methods. Under intermittent fluoroscopic imaging, the location of the ganglion can be determined by administering contrast media. We consider that determining the localization of the ganglion with this method during pulse radiofrequency application can shorten the procedure time. In this way, we believe that it would help the correct application of the procedure.

Start: March 2021

Different Dosage of Decompression Therapy on Symptoms of Lumbar Radiculopathy

This study will provide evidence about how much dose of decompression more effective for the treatment of lumbar radiculopathy. As this hypothesis has no evidence about the dosage of decompression in literature till now.

Start: October 2020

MORE in the Management of Lumbosacral Radiculopathy Symptoms: A Randomized Controlled Trial

INTRODUCTION: Chronic low back pain (CLBP) is a ubiquitous musculoskeletal (MSK) complaint that often presents as a chronic and difficult to treat condition. Lumbosacral radiculopathy/radiculitis (LR) or "sciatica" is a common secondary condition that can last well beyond the expected time frame after treatment with physical therapy, oral anti-inflammatory medications, local steroidal injections, and surgery. Challenges in the treatment of LR indicate that persistent pain may have evolved from mechanical to neuropathic. Previous research has shown that, in addition to the aforementioned treatments, mindfulness-based stress reduction (MBSR) is effective in limiting self-reported pain in patients with CLBP and neurogenic conditions such as fibromyalgia. This study proposes a randomized clinical trial to evaluate the effects of a newer mindfulness program, Mindfulness Oriented Recovery Enhancement (MORE), on self-reported pain, physical function, quality of life (QoL), depression symptoms, trait mindfulness, reinterpretation of pain, and surface electromyography (sEMG) findings in patients with LR. METHODS: Participants will be recruited from the Portland, OR metro area. Upon screening and recruitment, participants will receive a battery of questionnaires collecting demographic, self-reported pain, physical function, QoL, depression symptoms, mindfulness, and reinterpretation of pain data. Participants will also undergo sEMG to identify neurological abnormalities that can be characterized diagnostically. Upon enrollment, participants will be randomized to either the mindfulness-based intervention group (MBI), MORE; or the control group, treatment as usual (TAU), for 8 weeks. Self-reported pain measures and sEMG studies will be conducted again at eight weeks post randomization. HYPOTHESES: Primarily, investigators hypothesize that MORE will be effective in improving self-reported pain, physical function, QoL, depression symptoms, mindfulness, and reinterpretation of pain scores after eight weeks of mindfulness training. Secondarily, investigators hypothesize that those individuals with abnormal sEMG findings at baseline will have improved sEMG findings at their eight-week follow-up visit. ANALYSIS PLAN: Changes in self-reported pain, physical function, QoL, depression symptoms, trait mindfulness, and reinterpretation of pain will be analyzed using descriptive statistics as well as ANCOVA. Regression will also be used to evaluate the dose-response relationship between all outcome measures and time spent in mindfulness practice for the intervention group. Finally, ANCOVA will be used to evaluate the relationship between pain and physical function and sEMG findings.

Start: February 2021

Pentoxifylline and Lumbar Radiculopathy

The objective of this prospective controlled crossover study is to evaluate the efficacy and safety of pentoxifylline per os (800 mg daily) in the management of lumbar radiculopathy

Start: January 2016

In Turkish Version Lumbar Spine Surgery Expectation Survey

The aim of this study was to determine the Turkish validity and reliability of Lumbar Spine Surgery Expectations Survey developed by Mancuso.

Start: February 2021

Effects of ELDOA in Lumber Radiculopathy

ELDOA is the most beneficial intervention treating for lumbar pathologies such as radiculopathy. This study was a randomized control trial in which data was collected from Riphah Rehabilitation and Research Centre and Pakistan Railway Hospital-IIMCT. Purposive sampling technique was used for data collection. Research data was recorded by using prescribed validated questionnaire, NPRS and ODI. After taking consent from patients, patients were divided randomly in two groups through lottery method. Group A was treated with ELDOA and mobilization, group B was treated with only mobilization. It was observed that both groups showed improvement but ELDOA group showed more significant results.

Start: August 2017

Safety and Efficacy of SX600 Administered by Lumbosacral Transforaminal Epidural Injection for Radicular Pain

This is a Phase I/II, double-blind, parallel-group, randomized, placebo-controlled multi-centre trial in 180 patients randomized 1:1:1 to receive the IMP (Dexamethasone acetate microspheres for extended-release injectable micro-suspension, SX600 at 12.5 mg or 25.0 mg) or Placebo (0.9% Sodium Chloride for Injection, BP) via transforaminal epidural injection to the lumbosacral epidural space.

Start: September 2019

Prediction of TEI Success in Sciatica

Rationale: Treatment with transforaminal epidural injections is part of usual care in patients suffering from sciatica. 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 determine the average leg pain score two weeks after treatment with TEI in patients with sciatica due to LDH and due to spinal stenosis. Secondary: to determine the average score for leg pain, back pain, functionality, anxiety and depression, pain coping, patient satisfaction and overall health status postprocedural and at 2 weeks and 6 weeks after TEI, and to explore radiological and clinical factors that predict TEI success. Study design: Prospective cohort study Study population: Patients that are scheduled for TEI as part of usual care suffering from a first episode of sciatica Main study parameters/endpoints: The mean leg pain score at 2 weeks after treatment with TEI. Leg pain, back pain, functionality, patient satisfaction, anxiety and depression, pain coping and quality of life post-procedural and at 2 and 6 weeks follow-up.

Start: October 2020

Diffusion Tensor (DTI) for the Assessement of Therapeutic Evolution of Patients With Acute Lumbar Radiculalgia

Diffusion tensor imaging (DTI) is a non-invasive MRI technique offering a functional approach that provides morphological information about the microstructures of the nerve roots. DTI is a widely used neuroimaging technique and is a current topic of research in the field of peripheral nerve imaging.The aim of the study is to determine the prognostic quality of the DTI parameters to predict the therapeutic evolution of patients with lumbar radiculalgia at 6 months.

Start: January 2021

The Effect of Transcranial Magnetic Stimulation Therapy in Patients With Lumbar Radiculopathy

The present study aims to investigate the efficacy of repetitive transcranial magnetic stimulation of the motor cortex combined with transforaminal epidural steroid injection in patients with chronic lumbar radiculopathy.

Start: November 2019

Clinical Effect of Preventive Use of Tylenol on Fever After Removal of Drainage Tube in Lumbar Fusion Surgery

This study evaluates the influence of Non-steroidal Anti-inflammatory Drugs on preventing fever after the removal of drainage tube in the patients who suffered lumbar fusion surgery, if the outcome turn out positive, the preventive use of non-steroidal anti-inflammatory drugs could decrease the possibility of fever happening when we remove the tube.

Start: June 2019