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NCT07304076
A multicenter randomized controlled trial
NCT06662032
Low Back Pain (LBP) is one of the common causes of morbidity worldwide, with a one-month prevalence of 23.3 %. Number of people with LBP reached 577 million people in 2020. LBP has been the leading cause of years lived with disability from 1990 to 2017. The highest incidence of LBP is in people in their third decade of age. LBP is a complex disease difficult to treat as most of these cases (80 - 90 %) are classified as non-specific meaning that the pain cannot be attributed to any specific injury or pathology. Until now exercise therapy is commonly used as the treatment of choice in the rehab program of LBP. The aim of physical treatment is to improve function and prevent disability from getting worse. LumbaCure® is a robotic system driven by a proprietary movement algorithm to induce a specific and controlled mobilization of the low back in patient requiring treatment by physical exercises due to orthopedic disorder, especially low back pain. In Belgium, the standard back-school programme (rehabilitation programme) includes 35 rehabilitation sessions of 2 h delivered 2x/week at the investigator site (whom the first session is the inclusion visit, no therapy performed) and one session to tackle the psychological component of the condition (information on how to cope with pain). Participants are divided into two groups: the intervention group uses the LumbaCure® device (a seat that mobilizes the lower back for 15 minutes) in addition to the standard sessions (from session 2 to 27), while the control group follows the standard program with an extra 15 minutes of exercises. After session 27 (around 13 weeks), all participants continue their programme without the LumbaCure®, and their progress is assessed before the final 35th session.
NCT07306364
The purpose of this research study is to investigate whether a single administration of psilocybin can improve interoceptive awareness (awareness of bodily sensations) in individuals with chronic low back pain undergoing physical therapy, and whether these improvements are linked to pain relief and better physical therapy outcomes.
NCT06973837
This study is a part of a larger project aiming to evaluate the neurobiological mechanisms underlying the relationship between sleep and pain in people with non-specific chronic low back pain. Specifically, this study aims to evaluate the neurobiological mechanisms underlying the relationship between chronic sleep disturbances and pain sensitivity in people with non-specific chronic low back pain and chronic insomnia.
NCT07078019
This study aims to investigate whether pain intensity (assessed by Visual Analog Scale - VAS) and functional impairment (Roland-Morris Disability Questionnaire \[RMDQ\] or Oswestry Disability Index \[ODI\]) in patients with chronic low back pain can be estimated using acoustic features extracted from short voice recordings.
NCT07176845
Low back pain (LBP) is a major health problem in Switzerland and worldwide. Globally, LBP remains the leading cause of years lived with disability and its incidence and associated socioeconomic consequences are predicted to increase in the coming decades. In Switzerland, the condition is one of the most commonly reported physical complaints and negatively affects quality of life, resulting in significant personal burden and personal financial burden. LBP also generates enormous socioeconomic costs, with both direct and indirect costs estimated to reach billions of Swiss francs in Switzerland annually. Therefore, it is essential that LBP prevention, diagnosis, and management are improved. LBP is a multifactorial condition. Social, psychological and biophysical factors, along with comorbidities and genetic factors, influence LBP development and associated disability. In individuals with LBP, psychological factors, such as pain catastrophizing, are associated with higher pain intensity and developing chronic LBP and the associated disability. Among biophysical factors, altered spinal motor behaviour (e.g. smaller trunk movement amplitude) and reduced physical activity have been observed in LBP patients and suggested to influence LBP. However, exactly how all these factors influence LBP and how they are interrelated remains unclear. In particular, the effect of altered spinal motor behaviour on LBP is not understood. However, altered motor behaviour could play an important role in changing LBP and related disability. Therefore, improving our understanding of the patterns of spinal motor behaviour and the interrelationships with other factors in LBP would increase our understanding of LBP progression and could help improve LBP management. This study consists of a 6-month prospective longitudinal cohort observation of spinal motor behavior, physical activity, psychological factors, pain intensity, and disability in LBP patients (300 acute, 300 chronic LBP). Data collection will occur remotely and the frequency of repeated measures will be daily or weekly, depending on the measure. A custom smart-phone application will be used by participants to collect data on spinal motor behavior, psychological factors, pain intensity, and disability. Physical activity will be monitored using a wearable physical activity tracker. Established trajectories of motor behavior will be investigated for potential interrelations with trajectories of other parameters (e.g. pain, psychological factors, and disability), to explore potential causal effects. In addition, risk factors or predictive factors for certain trajectories of motor behavior and other parameters will be identified. As such, this study will allow us to investigate the temporality of these relationships and identify LBP, and in particular spinal motor behavior, phenotypes.
NCT07172828
Chronic low back pain is a common musculoskeletal disorder that causes pain, disability, and reduced quality of life. It is often related to changes in trunk muscle function, thoracolumbar fascia morphology, and impaired balance control. Although conventional motor control exercises are effective, patient motivation and adherence can be limited. Virtual reality (VR)-based rehabilitation offers interactive and engaging environments that may improve compliance and provide additional therapeutic benefits. This study is a randomized controlled trial designed to investigate the effects of VR-based rehabilitation compared with conventional motor control exercises in individuals with chronic low back pain. A total of 40-50 participants aged 18-65 will be recruited and randomly assigned to one of two groups: (1) VR-based rehabilitation or (2) conventional exercise therapy. Both programs will last 8 weeks, delivered three times per week for 40 minutes per session. The primary outcomes include muscle architecture assessed by ultrasound imaging, thoracolumbar fascia morphology, and postural balance control measured by force platform tests. Secondary outcomes include pain intensity, disability, fear-avoidance beliefs, quality of life, and patient satisfaction. The findings of this study are expected to provide new insights into the role of VR in rehabilitation and contribute to evidence-based strategies for managing chronic low back pain. By exploring the effects on both physical and patient-reported outcomes, the study may highlight innovative approaches to improve adherence, reduce pain, and enhance daily function in affected individuals.
NCT07163117
Low Back Pain (LBP) as estimates show that up to 84% of adults will experience LBP at some point in their lifetime, ranking it as a leading cause of disability globally. If the pain lasts more than 12 weeks and remains difficult to manage effectively, it can be called Chronic low back pain (CLBP). Physical therapy interventions play an important role in the non-pharmacological management of CLBP including lumbar stabilization exercises (LSEs) and back extension/endurance exercises which are commonly prescribed modalities that may help in improving the spinal function, reducing pain and improving the quality of life in general.
NCT06963658
Randomized control trial to examine the immediate effect of isometric exercise on pressure pain threshold (PPT) in adults with chronic low back pain. The secondary aim of this study was to investigate the acute effects of isometric exercise on clinical pain intensity.
NCT06868173
Electroacupuncture is an application of acupuncture combined with electrical stimulation of acupuncture points through acupuncture needles to achieve faster pain relief than acupuncture. Recently, research has shown that Trigger point acupuncture has a significant effect in reducing pain better than acupuncture on acupoints in patients with chronic low back pain. However, no research has compared the pain relief effect between Trigger Point electroacupuncture and electroacupuncture on acupoints in patients with chronic low back pain. This study was conducted to address this question.
NCT07148635
This study will evaluate the effectiveness of electrical dry needling (EDN) compared to sham dry needling (SDN) in patients with chronic low back pain (CLBP). CLBP is a common musculoskeletal condition associated with persistent pain, functional limitations, and reduced quality of life. Myofascial trigger points (MTrPs) are often implicated in CLBP and represent a key therapeutic target. Dry needling is a minimally invasive procedure where fine needles are inserted into trigger points to release muscle tension and alleviate pain. Electrical dry needling is an advanced variation that applies low-frequency electrical stimulation through the inserted needles, potentially enhancing therapeutic effects. However, evidence is limited regarding its superiority over sham procedures. In this randomized controlled trial, 70 adult participants with CLBP persisting for at least three months will be randomly assigned to one of two groups: Group A (EDN + Conventional Therapy): Patients will receive electrical dry needling at active MTrPs combined with a structured physiotherapy program. Group B (SDN + Conventional Therapy): Patients will receive sham dry needling at the same anatomical sites (using superficial or blunt needle placement without penetration) alongside the same physiotherapy program. Interventions will be delivered weekly for six weeks. Assessments will occur at baseline, third week, and sixth week. Primary outcomes include: Pain intensity (Visual Analogue Scale, VAS) Functional disability (Roland-Morris Disability Questionnaire, RMDQ) Kinesiophobia (Tampa Scale of Kinesiophobia, TSK) This trial is designed to clarify the clinical value of EDN beyond placebo effects, providing evidence to guide management of CLBP.
NCT06944730
The goal of this project is to assess if Chronic Low Back Pain (CLBP) participant's movement quality and balance variables can change after training that decreases their pain and disability. It will also compare the difference between structural exercise (SE) and isolated trunk exercise (ITE). The main questions it aims to answer are: 1. What are the effect of the training on the participant's movement quality and balance. 2. What are the difference between different types of trunk muscle training on people with CLBP. Researchers will compare SE, ITE and control. Control group will receive back school education that was shown not to be effective in reducing pain and disability. Participants will: 1. Do home and in-lab based SE or ITE training, or maintain active daily living over 2 months. 2. Complete the pain and disability questionnaire and do several physical functioning tests while having their trunk and lower limb movement and muscle activation measured.
NCT06890793
This is a cross-sectional study designed to evaluate potential differences in heart rate variability (HRV) indices based on the affected body region (cervical vs lumbar) in individuals with chronic pain. The study will compare HRV parameters between three groups: individuals with chronic neck pain (CNP), individuals with chronic low back pain (CLBP), and a control group without pain. HRV will be assessed using a Firstbeat Bodyguard® device over a 10-minute period, and the data will be analyzed with Kubios® HRV software. The study aims to determine whether autonomic nervous system modulation differs depending on the location of chronic pain.
NCT06627101
Chronic low back pain (CLBP) is classified as one of the leading causes of disability worldwide. Furthermore, the painful experience of CLBP can be influenced by some already established factors, such as beliefs, self-efficacy, and kinesiophobia. Beliefs are pre-established ideas that can influence physical functionality, pain experience, social functioning, and adherence to CLBP treatment Clique ou toque aqui para inserir o texto. Among them is Traditional Medicine, a practice carried out by some populations that continue to trust their own popular medicine to meet their health demands. According to the WHO, Traditional Medicine (MT) or Popular Medicine (MP) is a practice reproduced in different cultures and based on beliefs, the sum of experiences and knowledge, whose objective is to prevent, treat or cure illnesses, whether physical or mental. This habit includes the use of home remedies, which are based on the manipulation of plant, animal, and mineral extracts for therapeutic purposes. Furthermore, it is important to point out that, as it is a chronic condition, individuals living with CLBP are strongly influenced by psychological factors, such as kinesiophobia (avoidance of exercise), catastrophizing (intensifying fear of movement, as they feel that pain is a threat), and low self-efficacy in processing and modulating pain, increasing levels of pain and disability. Also, in addition to this, socioeconomic level is one of the determinants of the incidence and intensity of chronic pain. In short, although the practice of TM has been recognized for decades, it is not known whether there is a relationship between this belief and the levels of self-efficacy, kinesiophobia and catastrophizing of individuals with CLBP in Northern Brazil. Therefore, this study aims to identify the use of TM and its impacts on the functional activities and quality of life of individuals with CLBP in the northern region of Brazil. This is a cross-sectional observational study. Individuals participating in this research will be invited to respond online to the questionnaire prepared by the authors of this study. Continuous data will be analyzed descriptively using mean and standard deviation; categorical data will be described in frequency form, and the normality of the data will be analyzed to identify the possibility of using parametric or non-parametric statistical tests.
NCT06453291
This clinical trial aims to assess the effectiveness of different clinical techniques in treating patients with chronic low back pain (CLBP). Two test groups will be included: one receiving conventional therapy (NSAIDs and other physical therapy techniques) and the other receiving a combination of neuromodulation and platelet-rich plasma (PRP) therapy. Chronic pain, persisting for more than three months, inhibits natural pathways like GABA and promotes excitatory pathways, leading to increased inflammation. The study hypothesizes that neuromodulation via the dorsal root ganglion (DRG) and PRP therapy will provide superior pain relief and functional improvement compared to conventional therapy.
NCT02609854
ZetrOZ's Ultrasonic Diathermy device is intended for use as a portable and wearable medical device which, when applied to various areas of the body applies Low Intensity Therapeutic Ultrasound (LITUS) to deep tissues. This device is FDA-cleared for pain reduction, treatment of muscle spasm and joint contracture, and increasing local circulation. This study will look at the use of therapeutic ultrasound to relieve pain and reduce disability in subjects with chronic low back pain, a subset of which will have chronic low back pain due to a herniated disc, over an 8-week treatment period.