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Spinal Diseases clinical trials

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NCT ID: NCT04120272 Recruiting - Spinal Disease Clinical Trials

Discovery for Biomarkers and Risk Factors for Postoperative Delirium in Elderly Patients With Spine Surgery

Start date: October 21, 2019
Phase:
Study type: Observational

Introduction: With the increase of the elderly population, the number of elderly patients undergoing surgery is increasing, and postoperative delirium is 11-51% depending on the type of surgery. In recent cohort studies have shown that delirium might reduce cognitive function and develop dementia. Since delirium is difficult to treat, the key to treatment is prevention, and about 40% is prevented when prophylactic intervention is applied. However, delirium is difficult to diagnose and difficult to predict, therefore, biomarkers are needed to diagnose and prevention. Exosome and brain efficiency test(electroencephalogram, and pulse wave test) have the potential of simple biomarkers that can diagnose postoperative delirium and predict cognitive decline. Purpose: The purpose of this study is to investigate the risk factors affecting delirium in the elderly who have spinal surgery and to search for biomarkers of delirium for early detection and prevention of delirium.

NCT ID: NCT04119466 Completed - Clinical trials for Degenerative Disc Disease

Stabilizing Training in Degenerative Disc Disease

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

This study evaluates efficacy of stabilizing training of deep core muscles in the lumbar spine in degenerative disc disease subjects, considering the progression level of degenerative disc disease: protrusion or extrusion.

NCT ID: NCT04114604 Completed - Clinical trials for Spinal Cord Injuries

Respiratory Capacity and Swallowing Function in Spinal Disorders: A Pilot Study

Start date: March 30, 2017
Phase:
Study type: Observational

This study is part of a larger grant, for which the overall goal is to collect measurements of liquid flow through the oropharynx (i.e., mouth and throat) during swallowing.The focus of this study is to evaluate the flow of liquids of varying consistency in the spinal disorder population.

NCT ID: NCT04101513 Withdrawn - Parkinson Disease Clinical Trials

The Natural History of Parkinson's Disease-associated Spinal Disorders

Start date: February 14, 2019
Phase:
Study type: Observational

This is a prospective single-institution longitudinal study to access quality of life and serial imaging and biodynamic testing to assess spinal disorders associated with Parkinson's disease patients.

NCT ID: NCT04062942 Completed - Clinical trials for Lumbar Spinal Stenosis

The Six-Minute Walking Test (6WT) and Timed-Up-and-Go (TUG) Test as Measures of Objective Functional Impairment in Patients Undergoing Interlaminar or Transforaminal Epidural Steroid Injection for Lumbar Degenerative Disc Disease (DDD)

Start date: July 15, 2019
Phase:
Study type: Observational

The primary objective is to determine the validity of the Six-Minute-Walking Test (6WT) and Timed-Up and Go (TUG) test to measure objective functional impairment (OFI) in patients undergoing either interlaminar epidural steroid injection (ESI) or transforaminal epidural steroid injections (TFESI) for lumbar degenerative disc disease (DDD)

NCT ID: NCT04042844 Recruiting - Lumbar Disc Disease Clinical Trials

A Single Dose of BRTX 100 for Patients With Chronic Lumbar Disc Disease (cLDD)

Start date: June 30, 2022
Phase: Phase 2
Study type: Interventional

This is a double-blind, saline-controlled, and randomized study with blinded assessments using a single dose. Subjects that have a current diagnosis of chronic lumbar disc disease and meet eligibility criteria will be enrolled. Chronic lumbar disc disease is defined as back and/or radicular pain with degeneration of the disc confirmed by patient history, physical examination, and radiographic measures such as computed tomography (CT), magnetic resonance imaging (MRI), plain film, myelography, discography, or other acceptable means.

NCT ID: NCT04008459 Terminated - Osteoporosis Clinical Trials

Walking and Balance Related to Sagittal Spinal Posture Alignment

WiSPA
Start date: April 6, 2019
Phase:
Study type: Observational

This study aims to improve understanding of the relationship between spinal alignment and walking and balance in people who have degenerative spinal conditions.

NCT ID: NCT03977961 Completed - Clinical trials for Lumbar Spinal Stenosis

The Six-Minute Walking Test (6MWT) as a Measure of Functional Impairment in Lumbar Degenerate Disc Disease.

6MWT-DDD
Start date: May 1, 2019
Phase:
Study type: Observational

The study determines the reliability and validity of the 6-Minute Walking Test (6MWT) in patients with lumbar degenerative disc disease (DDD).

NCT ID: NCT03969602 Recruiting - Clinical trials for Lumbar Spinal Stenosis

Cognitive Behavioral Therapy (CBT) After Lumbar Spinal Fusion in Patients With High Pain Catastrophizing

TRIBECA
Start date: January 23, 2020
Phase: N/A
Study type: Interventional

Catastrophizing has emerged as the strongest independent predictor for persistent postsurgical pain. Although behavioral interventions, including Cognitive Behavioral Therapy (CBT), have been shown to reduce the impact of persistent pain, postsurgical patients have not historically been offered these interventions. The aim of our study is to examine whether an intervention targeting pain catastrophizing can reduce the risk of persistent pain and disability after spinal fusion. Our primary hypothesis is that a perioperative cognitive behavioral intervention with the goal to decrease anxiety and pain catastrophizing will decrease the risk of persistent pain and disability after spinal fusion surgery in high catastrophizing patients. To study this hypothesis the investigators will perform a prospective, randomized, controlled multicenter trial with 1:1 allocation, comparing 2 cohorts. Patients aged > 18 years/old, with a primary diagnosis of spinal stenosis, degenerative or isthmic spondylolisthesis or degenerative disc disease (DDD) determined by expert spine surgeons and selected for lumbar spinal fusion surgery with decompression will be screened for high levels of pain catastrophizing using the Pain Catastrophizing Scale (PCS). Patients with a score of ≥ 24 on the PCS who will consent to the study will be randomized to CBT (2 sessions preoperatively and 4 sessions postoperatively) plus usual care (experimental group) or usual care (control group). To limit expectation bias, an educational intervention will be added in the control group. Primary outcome is the Core Outcome Measure Index (COMI) at 12 months. Secondary outcomes are scores on 11-point Numeric Rating Scale (NRS) for back and leg pain, Oswestry Disability Index (ODI), Patient-reported outcomes measurement - depression (PROMIS-D), Patient Global Impression of Change (PGIC), Pain Catastrophizing (PCS), reliance on analgesics and employment status. NRS will be measured on the 4th postoperative day, at 8 weeks, 6 months and 1 year, while all other outcomes will be measured at 8 weeks, 6 months and 1 year.

NCT ID: NCT03962530 Not yet recruiting - Sarcopenia Clinical Trials

Spinal Sarcopenia Cohort Study (SarcoSpine)

SarcoSpine
Start date: August 2019
Phase:
Study type: Observational

Sarcopenia on lumbar paraspinal muscles is receiving renewed attention as a cause of spinal degeneration. However, there are few studies on the precise concept and diagnostic criteria for spinal sarcopenia. Here, we develop the concept of spinal sarcopenia in community-dwelling healthy elderly people. In addition, we aim to observe the natural aging course of paraspinal muscle and back muscle strength, and investigate the association between conventional sarcopenic indices and spinal sarcopenia. This is a prospective observational cohort study with 120 healthy community-dwelling elderly people for 4 years. All subjects will be recruited according to no sarcopenia, possible sarcopenia, sarcopenia, and severe sarcopenia groups. The primary outcomes of this study are isokinetic back muscle strength and lumbar paraspinal muscle quantity and quality using lumbar spine MRI. Conventional sarcopenic indices and spine specific outcomes such as spinal sagittal balance, back performance scale, and Sorenson test will be also assessed. The data will be analysed using the intention-to-treat principle.