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Radiculopathy clinical trials

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NCT ID: NCT03842072 Recruiting - Clinical trials for Cervical Radiculopathy

The Collar Post Anterior Cervical Spine Surgery Study

C-PASS
Start date: February 23, 2018
Phase: N/A
Study type: Interventional

The Anterior Cervical Discectomy and Fusion (ACDF) represents one of the most commonly performed spinal operations internationally, often in the context of symptomatic radiculopathy or myelopathy secondary to cervical degenerative disease. Approximately half of surgeons continue to prescribe a period of post-operative bracing with a cervical collar. However, there is currently no high quality evidence available to support the routine use of post-operative bracing after ACDF; further, braces are expensive and have been associated with a variety of local complications. In summary, the current lack of evidence, and lack of consensus amongst surgeons, regarding best practices in the use of post-operative bracing after ACDF, places the surgeon and the patient in a precarious position. Our randomized trial comparing the impact of 6 weeks of post-operative bracing with a rigid cervical collar vs. no post-operative bracing, on a variety of clinical and radiological outcomes, for adult patients with cervical radiculopathy and/or myelopathy undergoing single or multi-level ACDF.

NCT ID: NCT03636009 Recruiting - Clinical trials for Spinal Nerve Root Disorder Nos

Concurrent Treatment for Patients With Cervical Radiculopathy

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

This study evaluates the effectiveness of two treatment interventions in patients with cervical radiculopathy. One group will receive a concurrent approach using traction and neuromobilizations. The other group will receive the sequential approach of traction and neuromobilizations

NCT ID: NCT03556137 Recruiting - Neuropathic Pain Clinical Trials

PET/MRI in the Diagnosis of Chronic Pain

Start date: July 16, 2018
Phase: Phase 1
Study type: Interventional

Several studies have implicated involvement of sigma-1 receptors (SR1s) in the generation of chronic pain, while others are investigating anti SR1 drugs for treatment of chronic pain. Using [18F]-FTC-146 and positron emission tomography/magnetic resonance imaging (PET/MRI), the investigators hope to identify the source of pain generation in patients with chronic pain. The purpose of this study is to compare the uptake of [18F]FTC-146 in healthy volunteers to that of individuals suffering from chronic pain.

NCT ID: NCT03502057 Recruiting - Clinical trials for Degenerative Disc Disease

P-15L Bone Graft Lumbar Fusion Clinical Trial

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

Study Design: Prospective, single-blinded, multi-center, randomized, controlled, pivotal study Study Objective: To evaluate if P-15L is not inferior in effectiveness and safety to local autologous bone (and allograft as extender where necessary) when applied in instrumented TLIF in subjects with Degenerative disc disease (DDD) Study Endpoints: Primary endpoint: Month 24 Composite Clinical Success (CCS): - Achievement of fusion (Evidence of continuous trabecular bridging bone in the intervertebral space) - At least 15-point improvement in Oswestry Disability Index (ODI) - No new or worsening, persistent neurological deficit - No subsequent surgical intervention at the index level Once fusion is radiographically confirmed, it will be assumed that fusion has occurred at all subsequent time points without the need to reconfirm fusion status at later time points. Multiplicity Controlled Secondary endpoint: • Visit at which fusion is confirmed. Other Secondary endpoints: - Visual Analog Scale (VAS) pain scores, changes over time, and achievement of a 20 mm improvement (Back, left leg, right leg); - Physical Function and Mental Health Composite Scores (Short Form Health Survey SF-12 and changes over time).

NCT ID: NCT03185442 Recruiting - Chronic Disease Clinical Trials

Cerebral Effects of Pulsed Radiofrequency on the Lumbar Dorsal Root Ganglion With Functional Magnetic Resonance Imaging.

Start date: July 2, 2018
Phase: N/A
Study type: Interventional

Evaluation of central (cerebral) effects of Pulsed RadioFrequency (PRF) on the lumbar DRG (Dorsal Root Ganglion), using fMRI (functional Magnetic Resonance Imaging ). Feasibility study (after which an interim analysis is done): 5 subjects in order to detect measurable central effects inducted by PRF on DRG, follow up study 20. Total amount of subjects 25.

NCT ID: NCT03023696 Recruiting - Clinical trials for Radiculopathy, Cervical

Can Prophylactic Foraminotomy Prevent C5 Palsy

Start date: June 2016
Phase: N/A
Study type: Interventional

C5 palsy (C5P) is a well-known, although rare complication of cervical spine decompression surgery. In severe forms, C5P causes debilitating upper extremity weakness involving the deltoids and/or biceps brachii muscles, ultimately diminishing these patients' quality of life. Furthermore, about half of patients with C5P present with sensory deficits and/or intractable pain in addition to the muscle weakness. Prophylactic bilateral foraminotomy at the C5 level during cervical decompression surgery has been studied recently with the hope that it will minimize the risk of developing a C5 nerve root palsy postoperatively. Although the current literature provides some support for this claim, there are insufficient data establishing this technique as a proven measure to reduce the incidence of C5P. In the present study, we seek to evaluate the effect of bilateral foraminotomy on postoperative C5P incidence rates. Bilateral foraminotomy has been correlated with a reduced risk of developing C5P following cervical decompression surgery, but an identical foraminotomy procedure has never been applied in a randomized manner to all qualifying patients in a study. Additionally, prophylactic foraminotomy has only been prospectively studied during laminoplasty. In the proposed study, bilateral foraminotomy will be randomized to patients receiving cervical decompression surgery (laminoplasty, laminectomy, fusion). This is a multicenter randomized trial, including the following sites: Cleveland Clinic, Columbia University Medical Center, and University of Southern California Spine Center. Patients undergoing cervical decompression surgery will be consented and enrolled if they meet the inclusion and exclusion criteria. Subsequently, incidence of C5P will be monitored to determine efficacy of prophylactic C5 bilateral foraminotomy during cervical decompression.

NCT ID: NCT02449200 Recruiting - Clinical trials for Cervical Radiculopathy

RCT of Multimodal Physiotherapy for Acute / Sub-acute Cervical Radiculopathy

PACeR
Start date: May 2015
Phase: N/A
Study type: Interventional

Multimodal physiotherapy involving manual therapy and exercise has demonstrated a positive effect on pain and disability in sub-acute and chronic cervical radiculopathy (CR) but a research gap exists for optimal management in the first 12 weeks and short-term natural history of the condition is unclear, although thought to be favourable within the first 4 weeks. The primary aim of this single blind, 2 group randomised controlled trial (RCT) is to investigate the effects of a 4 week (6-8 sessions) programme of manual therapy, exercise and upper limb unloading tape compared to advice to stay active, on disability, pain and other biopsychosocial measures, in acute / sub-acute cervical radiculopathy patients. The hypothesis is that a 4 week multimodal physiotherapy programme will lead to changes in self-reported disability and pain, compared to advice to stay active, in patients with acute / sub-acute cervical radiculopathy. A secondary study objective is to identify whether variables from the baseline examination, group allocation and aetiology confirmed by MRI can predict outcome, as measured with the Global Rating of Change Scale (GROC). Subjects will be diagnosed with CR based on a diagnostic clinical prediction rule. Random group allocation, allocation concealment, blinded assessment and intention to treat analysis will be employed. Outcomes will be measured at baseline, 4 and 12 weeks. Patients' report of pain, disability and their rating of recovery will also be recorded by telephone interview at 6 months. An internal pilot feasibility study will be undertaken in advance of the main study to test recruitment and retention strategies. Statistical analysis of differences between groups will be done with ANOVAs and MANOVAs. Appropriate multivariable regression analysis will be used to explore predictors of outcome.

NCT ID: NCT01988259 Recruiting - Clinical trials for Single Brachial Radiculopathy

Head-neck Coordination Analysis After Minimally Invasive Surgery in the Dorsal Cervical Spine

MISDCS
Start date: September 2013
Phase: N/A
Study type: Interventional

To proof patients' benefit of minimally invasive surgery in the dorsal cervical spine an apparatus to examine head-neck-coordination was constructed. Two different surgical techniques will be compared: Laminoplasty: open approach vs minimally invasive surgery (MIS)-approach; Foraminotomy: open approach vs MIS-approach. Each patient will be tested before surgery, postoperative as well as 3 and 12 month follow-up. Hypothesis is that patients after MIS-approaches perform better in their head-neck-coordination as patients with open approaches.

NCT ID: NCT01875562 Recruiting - Clinical trials for Cervical Radiculopathy

A Post-marketing Evaluation of a Compound Traditional Chinese Herbal Medicine, Qishe Pill, on Cervical Radiculopathy

Start date: May 2012
Phase: Phase 4
Study type: Interventional

Neck pain is a common symptom in most patients suffering from cervical radiculopathy. However, some conservative treatments are limited by their modest effectiveness. On the other hand, surgical intervention for cervical disc disorders is indicated when symptoms are refractory to conservative treatments and neurological symptoms are progressive. Many patients use complementary and alternative medicine, including Traditional Chinese Medicine, to address their symptoms. The purpose of the present study is to examine effectiveness and safety of Qishe Pill, a compound traditional Chinese herbal medicine, for neck pain in patients with cervical radiculopathy.

NCT ID: NCT01500967 Recruiting - Clinical trials for Cervical Radiculopathy

Shi-style Cervical Manipulations for Cervical Radiculopathy

Start date: December 2011
Phase: N/A
Study type: Interventional

Neck pain and related problems occur frequently in modern societies and have a considerable impact on individuals and the society. Cervical radiculopathy (CR) generally presents with pain, numbness, or weakness in a dermatomal distribution. CR results from impingement on a nerve root by either spondylotic narrowing of the neural foramen or a lateral intervertebral disc herniation. Various studies have shown that nonoperative management for CR is effective, such as medications, physical therapy, Spinal manipulation, traction, acupuncture, collar immobilization and epidural steroid injections. Spinal manipulation is one of the manual techniques for treating mechanical neck pain. No high-quality evidence has proved the effectiveness of manipulative therapy in the treatment of cervical radiculopathy. However, limited evidence suggests that manipulation may provide short-term benefit in the treatment of neck pain, cervicogenic headaches and radicular symptoms. Few complications, such as worsening radiculopathy, myelopathy, and spinal cord injury, may occur. Spinal massage manipulation is used for centuries in China. Many patients with cervical disc disease are increasingly turning to manipulations to alleviate their symptoms and reduce the side effects of medications. The goal of this study is to determine the efficacy of a spinal manipulation, three steps and nine manipulations, on treating with the cervical radiculopathy.