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Low Back Pain clinical trials

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NCT ID: NCT03675152 Active, not recruiting - Low Back Pain Clinical Trials

Treatment of Spondylolysisin Pediatric Patients.

Start date: June 12, 2016
Phase: N/A
Study type: Interventional

A clinical trial comparing healing of unilateral or bilateral spondylolysis in children treated with a Boston thoracolumbar orthosis (brace) or with a soft spinal brace (Porostrap lumbar support) for four months. Inclusion criteria will be a child or adolescent aged between 8 and 20 years with an early uni- or bilateral defect (fracture line) in the pars interarticularis in the CT-scan with no signs of bony sclerosis. Additionally, bone marrow edema has to be confirmed in MR images (T2 sagittal) as a sign of an early lesion. Exclusion criteria will be spondylolisthesis on standing spinal radiograph, systemic skeletal disorder or lack of interest. Patient's preference defines the treatment method. Minimum follow-up time will be 2 years for all patients. According to statistical power analysis a total of 60 patients will be needed to provide evidence for the effectiveness or no effectiveness of rigid thoracolumbar orthosis on the natural history of early spondylolysis. Measured outcome parameters are 1) Bony healing on CT-scan, 2) SRS-24-score at the beginning of the treatment and during the 2-year follow-up, 3) Back and lower extremity pain at the beginning of the treatment and during the 2-year follow-up (Pain drawing including VAS-score in children under 16 years old, Oswestry disability index including VAS-score in patients over 16 years old), 4) Thoracolumbar radiographs at 2-year follow-up: Evidence of spondylolisthesis, 5) Trunk strength and spinal mobility at follow-up visits. As part of this study, the investigators will also evaluate patients with spondylolysis treated in their hospitals before this clinical trial begun. In this retrospective study they will evaluate all patients between 8 and 20 years of age with spondylolysis, which have been treated with thoracolumbar orthosis after year 2009 and are not participating in to prospective study. Main focus will be in bony healing in CT-scans after brace treatment.

NCT ID: NCT03640962 Active, not recruiting - Clinical trials for Postmenopausal Symptoms

Relationship in Sleep With Low Back Pain in Postmenopausal Period

Start date: April 2, 2018
Phase:
Study type: Observational [Patient Registry]

Introduction:The aim of this study was to investigate the incidence of low back pain in postmenopausal period and the relationship between low back pain and emotional state,sleep and quality of life i aimed at investigating low back pain during postmenopausal period of women and its correlation with the emotional state,sleep quality and the quality of life of woman. Method:This cross-sectional study was conducted in 368 postmenopausal women aged between 40 and 65 years.All participants were recorded frequency and severity of low back pain,depressive symptoms and anxiety,quality of life and sleep quality.Outcome measures are described in more detail below.

NCT ID: NCT03634046 Active, not recruiting - Clinical trials for Chronic Low Back Pain

PTED Versus Radiofrequency Ablation for Lumbar Disc Herniation

PTED
Start date: January 1, 2016
Phase: N/A
Study type: Interventional

Lumbar disc herniation (LDH) is a common and frequently-occurring disease giving rise to low back pain and (or) leg pain. There are about 1.5 million people with LDH-related pain, accounting for 10% of outpatients each year in China. The mechanism of LDH-related pain is that the degeneration causes the protrusion of the intervertebral disc directly to the lower lumbar nerve root or spinal cord, and the chemical stimulation plays a key role in it. Currently, LDH treatments are mainly divided into conservative treatment, surgical treatment and minimally invasive treatment. The minimally invasive technique is a new technology that has been arising in recent years, with small wound, little bleeding and quick recovery. It mainly includes collagenase dissolving, laser decompression, radiofrequency ablation, etc. Intervertebral disc radiofrequency ablation is an early application of minimally invasive technique with a wide range of applications in a long time. The percutaneous transforaminal endoscopic discectomy (PTED) is a new technique, which is applied in clinics with shorter time, and the implementation and efficacy of the technique need to be further discussed. A case-control clinical trial is designed to compare the efficacy and safety of PTED with radiofrequency ablation in the treatment of LDH. Main outcome is Visual Analogue Scale for leg pain, secondary outcomes are Oswestry disability index, quality of life assessment, Burns Depression Checklist, recovery rate, complications, operation time and radiation exposure time, etc. The follow-up time points are 7 days, 1 month, 6 months and 12 months post-operation.

NCT ID: NCT03581123 Active, not recruiting - Acute Pain Clinical Trials

Spinal Manipulation and Patient Self-Management for Preventing Acute to Chronic Back Pain

PACBACK
Start date: November 1, 2018
Phase: Phase 3
Study type: Interventional

This is a study of adults with acute low back pain flare-up at risk of becoming chronic and disabling. The study tests how well spinal manipulation and guided selfcare work compared to standard medical care. The treatments last up to eight weeks and participants will be followed for one year.

NCT ID: NCT03564600 Active, not recruiting - Clinical trials for Chronic Low Back Pain

Aging Back Clinics

Start date: January 3, 2019
Phase:
Study type: Observational

The purpose of this study is to compare two different ways to treat chronic low back pain. The two types of treatment that the investigators will compare are called Usual Care and ABC Care. Usual Care tends to focus on the spine. ABC Care focuses on the entire body and the mind. With Usual Care, participants will work with their own doctor to come up with a treatment plan. With ABC Care, participants will work with the investigators' ABC providers and their team. The investigators believe ABC Care will help reduce pain, lower costs, and increase participants' ability to do the things they enjoy doing better than Usual Care. In ABC Care the investigators hope to avoid treatments like surgeries where participants get metal rods put in their back. This research is being done at three Veterans Hospitals: the Veterans Administration of Pittsburgh Healthcare System (VAPHS) in Pittsburgh, PA; the North Texas VA Medical Center in Dallas, TX; and the Hunter Holmes McGuire VA Medical Center in Richmond, VA. This research study is being paid for by the Rehabilitation Research and Development section of the Veterans Health Administration. The investigators will be enrolling about 450 participants at 3 sites or around 150 at each site.

NCT ID: NCT03538470 Active, not recruiting - Clinical trials for Osteoarthritis, Knee

Assessment of the Effect of Spa Treatment on Rheumatological Conditions

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

1. Primary outcome measure: measuring the effect of spa treatment in patients suffering from lower limb osteoarthritis or any other lower limb rheumatological condition. Percentage of patients with minimum 19,9 mm decrease in pain Visual Analogue Scale (VAS) or WOMAC score (Western Ontario and McMaster Universities Arthritis Index) improvement of at least 9 points (minimal clinically important difference), 6 months after enrollment. Secondary outcome measures: 2. Measuring the effect of spa treatment in patients with concomitant chronic lower back pain. Percentage of patients presenting clinical benefits according to the EIFEL score, with a decrease of at least 5 points, 6 months after enrollment. 3. Quantitative evaluation of pain. Mean pain VAS comparison between enrollment and 6 months after spa treatment. 4. Quantitative evaluation of WOMAC score. Mean WOMAC score comparison between enrollment and 6 months after spa treatment. 5. Quantitative evaluation of EIFEL score. Mean EIFEL score comparison between enrollment and 6 months after spa treatment. 6. Impact of spa treatment on the patient's metabolism. Height and weight (BMI calculation), blood pressure and heart rate measured at enrollment and throughout the follow-up. 7. 8. Quality of life. 36-Item Short Form (SF 36) and EuroQol 5 Dimensions (EQ5D) questionnaires at enrollment, 3 months and 6 months. 9. Doctor and patient opinion. Semi-quantitative scale collected at enrollment, 3 months and 6 months. 10. Medicine consumption Daily medicine consumption evaluated upon the 72 hours preceding the medical visit at enrollment, 3 months and 6 months. 11. Auto-evaluation of pain VAS pain evaluation by the patient every 6 weeks for a more precise time frame of the treatment's effect.

NCT ID: NCT03427099 Active, not recruiting - Surgery Clinical Trials

The Effect of a Developed Perioperative Rehabilitation Pathway Following Lumbar Arthrodesis

Start date: January 3, 2018
Phase: N/A
Study type: Interventional

To compare the current rehabilitation pathway with the implementation of a newly developed rehabilitation pathway for patients with a single and double level lumbar arthrodesis.

NCT ID: NCT03419312 Active, not recruiting - Low Back Pain Clinical Trials

PET Patterns, Biomarkers and Outcome in Burst SCS Treated FBSS Patients

PET-SCS
Start date: February 11, 2018
Phase: N/A
Study type: Interventional

The primary aim of this study is to investigate cerebral mechanisms of burst stimulation in Failed Back Surgery Syndrome (FBSS) patients treated with Burst Spinal Cord Stimulation (SCS) for chronic back and leg pain. This study is a single center, prospective, blinded, randomized crossover trial with two 14 days treatment periods and two treatment arms (burst before sham stimulation or sham before burst stimulation).

NCT ID: NCT03255200 Active, not recruiting - Clinical trials for Chronic Low Back Pain

ReActiv8 Post Market Surveillance Registry

ReActiv8-C
Start date: October 9, 2017
Phase:
Study type: Observational [Patient Registry]

To gather data on the long-term safety of ReActiv8 and identify any residual risks by reporting all Serious Adverse Device Effects as well as performance and health care utilization through two years post-implant.

NCT ID: NCT03200509 Active, not recruiting - Low Back Pain Clinical Trials

Efficacy of a Multimodal Physical Activity Intervention in Patients With Chronic Nonspecific Low Back Pain

PAyBACK
Start date: August 31, 2017
Phase: N/A
Study type: Interventional

Physical activity plays an important role in the management of chronic low back pain (LBP). Engaging in an active lifestyle is associated with a better prognosis. Nevertheless, there is evidence to suggest that patients with chronic LBP are less likely to meet recommended physical activity levels. Furthermore, while exercise therapy has been endorsed by recent clinical practice guidelines, evidence from systematic reviews suggests that its effect on pain and disability are at best moderate and not sustained over time. A limitation of current exercises programs for chronic LBP is that these programs are not designed to change patient's behaviour toward an active lifestyle. Therefore, the objective of this study is to investigate the short and long-term efficacy of a multimodal intervention consisting of supervised exercises, health coaching and use of an activity monitor (i.e. Fitbit Flex) compared to supervised exercises plus sham coaching and a sham activity monitor on physical activity levels, pain intensity and disability in patients with chronic nonspecific LBP.