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Showing 1-20 of 834 trials
NCT03712527
Low back pain (LBP) is the second cause of medical visits in France. Indeed, its incidence can vary between 60 and 90%. LBP is also the leading cause of disability in the adult population in France and in the rest of the world. Its evolution towards chronicity is observed in less than 8% of cases, but it is responsible for 85% of the medical costs. Degenerative disk disease (DDD) is a major cause of chronic LBP (\> 40%). DDD can be characterized by peculiar Magnetic Resonance Imaging (MRI) features with a strong correlation between pain and inflammatory aspect of the disk, which result in the so-called active discopathy (AD) (Brinjikji et al. 2015). Modic classification based on MRI of the lumbar spine is considered as a reference. Type 1 Modic signal changes are characterised by a low-intensity signal on T1-weighted sequences and hyperintense signal on T2-weighted sequences, with gadolinium injection enhancement, corresponding to bone marrow oedema. Type 1 Modic is very rare in an asymptomatic population but may be found in 5% to 40% of chronic LBP patients underscoring its symptomatic involvement. No currently reference treatment is available for AD. PRP technology has recently been widely developed in osteoarthritis and tendon injuries. Therapeutic benefit of PRP has being evaluated. For instance, no randomized controlled trials (RCTs) have specifically evaluated the effect of PRP in AD (Modic 1 signal). The availability of PRP for intra- discal injection could become an innovative therapeutic option in humans, especially for AD forms where inflammatory process is clearly predominant. The objective of the study is to evaluate the 3-month efficacy on pain and function (by achieving 30% improvement in Oswestry Disability Index) of one intra-discal PRP injection versus placebo (saline solution) in subjects with LBP associated with AD lasting more than 3 months.
NCT07590050
The goal of this clinical trial is to learn if catgut embedding works to treat chronic low back pain in adults with lumbar spondylosis and "Blood Stasis" syndrome. The main questions it aims to answer are: Does catgut embedding lower back pain more effectively than electro-acupuncture? Does catgut embedding improve the daily physical activities of participants? Researchers will compare catgut embedding to electro-acupuncture to see which method works better to reduce pain and improve quality of life. All participants will also receive counseling on lifestyle changes and back exercises. Participants will: Be randomly assigned to receive either catgut embedding (2 sessions over 4 weeks) or electro-acupuncture (20 sessions over 4 weeks). Visit the clinic for treatments and checkups. Complete surveys about their pain levels and ability to perform daily tasks at the start, at 2 weeks, and at 4 weeks.
NCT06516770
This study aims to determine the effect of different stimulations including 1) transcranial direct current stimulation (tDCS), 2) neuromuscular electrical stimulation (NMES), 3) motor control exercise (MCE), and 4) isometric exercise (IE) on movement control and motor unit behavior in individuals with movement control impairment, and determine the correlation between movement control and motor unit behavior.
NCT05647629
The investigators are going to observe the appearance of low back pain in patients who have undergone hip prosthesis surgery.
NCT06821607
The investigators will conduct a prospective, randomized, clinical trial addressing key questions to understanding the effectiveness of telerehabilitation (physical therapy delivered via video-visits) and in-clinic physical therapy for patients with chronic low back pain (LBP). The investigators also seek to understand how patients engage with both care options and how these treatment options influence other LBP-related healthcare utilization. The investigators will explore implementation outcomes using a mixed methods approach consisting of electronic surveys and semi-structured interviews with patients, physical therapists, practice managers, and outpatient services administration focusing on perceived quality and impact on barriers to care. The investigators will enroll 1000 patients with chronic LBP seeking outpatient care at the healthcare systems in Maryland (Johns Hopkins Medicine (JHM)) and Utah (University of Utah (UU) and Intermountain Healthcare (IHC)). Eligible patients will provide informed consent and be randomized to receive telerehabilitation or in-clinic physical therapy delivered by a trained physical therapist. Primary effectiveness outcome is the difference in change in LBP-related disability (Oswestry Disability Index) after 8 weeks of treatment.
NCT04069572
The purpose of this study is to perform a first in man study with VCR stimulation of the belly and back for patients with chronic pain conditions including pelvic pain, functional abdominal pain, or low back pain. This study will also examine VCR stimulation of the temporal region for patients with migraine with or without aura. Additional goals of the study will be to determine the safety, tolerability, and acceptability of VCR stimulation for the treatment of these pain conditions.
NCT07543952
Non-specific chronic low back pain is one of the most prevalent musculoskeletal disorders worldwide and is associated with functional limitations and reduced quality of life. Exercise-based physiotherapy approaches are strongly recommended in clinical guidelines. Pilates exercises are frequently used due to their potential effects on core stability and movement control, while conventional physiotherapy remains a commonly applied treatment method. However, randomized controlled trials directly comparing these interventions are limited. This study aims to compare the short-term effects of reformer Pilates exercises and conventional physiotherapy on pain intensity, functional disability and health-related quality of life in individuals with non-specific chronic low back pain.
NCT05935761
Chronic pain symptoms are very common among U.S. Military Veterans and have a profound negative impact on mental health symptoms and quality of life, in addition to increasing risk for suicidal ideation and suicidal behaviors. There are currently extremely few safe and effective pharmacological treatments for chronic pain disorders, and the clinical need to develop new therapeutics for pain has never been more urgent. Fueled by the worsening opioid crisis and further exacerbated by the COVID-19 pandemic, opioid and other drug overdose deaths have climbed to staggeringly high levels. The rapid development of medications for the management of chronic pain conditions that are safe, well-tolerated, efficacious and non-addicting is thus of paramount importance. The two neurosteroid candidates to be investigated in this trial are naturally occurring molecules enriched in human brain and potentially ideal candidates for safe and effective chronic pain treatment.
NCT05345015
The purpose of this study is to examine the acute and chronic effects of high frequency electrical current transfer (frequently called "TECAR") on pain and functional movement in individuals with a musculoskeletal injury or pain. The participants will be assigned into an experimental or a control group and outcome measures will be measured prior to, after, 24 and 48 hours following a single intervention session (Acute effects) as well as 3 and 6 months after the intervention (chronic effects).
NCT06661850
This study is looking into how safe and useful NOCISCAN is. NOCISCAN is a software as a Service (SaaS) tool that uses Magnetic Resonance (MR) spectroscopy. Nociscan (instead of 'It') leverages MRS to noninvasively help physicians distinguish between painful and nonpainful discs in the lumbar spine. The randomized controlled trial will compare the blinded and unblinded cohorts and their corresponding surgical outcomes with the Nocigram reports, generated prior to treatment, for each patient."
NCT03406624
In the present study the investigators aim to examine the presence of bacteria in the disc and Modic Changes (MCs) (bone). A prospective study with 1-year follow-up of two patient populations undergoing elective spinal surgery (spinal fusion or disc herniation surgery) will be conducted. Patients previously operated on at index level will also be included, and evaluated as sub-groups. The following tissues are collected: dermis, sub-fascial tissue, nucleus pulposus, annulus fibrosus, and endplates. Endplate and anular biopsies are only performed in patients undergoing fusion surgery. In addition, air samples from the operating theatre during surgery are collected as negative controls. All tissue samples undergoing culturing should be processed within 4 hours of sampling. The time for sampling and culture processing is noted for each sample. Details are available in a published Method article. For each tissue sample, bacterial growth is recorded and identified at species level. Initially, the microbiologist grades the plates as "no growth", "possible contamination", and "significant growth". Possible contamination means that the bacteria may be derived from the environment and can be introduced at any step from the sample is taken to the analyses in the laboratory. The investigators will perform direct 16S rDNA nanopore sequencing on all frozen tissue samples and air samples. Other broad metagenomic methods may be considered, e.g., Illumina sequencing. Since Cutibacterium acnes is considered the main pathogen in this setting, the investigators will also use a specific quantitative PCR on all samples. In addition, the investigators will use whole genome sequencing on C. acnes isolates for phylogenetic analyses to compare isolates found in different samples from the same patient. Based on cultivation alone, samples will be graded as "significant growth", "possible contamination" or "no growth". Before unblinding, in preparation for the sensitivity analyses, "possible contamination" will be classified into a final categorization of "possible significant growth" or "no growth" based on PCR". In cases of a culture-negative nanopore-positive biopsy, the sample is classified as no growth when we find the same bacterial species in the air control sample as in the biopsy. Since the study was designed and the method article was prepared, nanopore sequencing technology has become available and incorporated into the present analysis. Although not part of the original protocol, nanopore sequencing was applied to the samples to complement the diagnostic approach. The results derived from nanopore sequencing will be included as part of prespecified sensitivity analyses to evaluate the robustness of the main finding. These analyses allow assessment of whether the inclusion of sequencing-based detection influences the overall estimates and conclusions, while maintaining the original study design. The microbiologists, the pathologist, statistician and clinicians are blinded until end of study. Blood-samples are collected to characterize gene expression patterns and related markers.
NCT07203430
The purpose of this study is to evaluate the longitudinal effects of a four-week dynamic resistance training program using the 45-degree Roman chair on pain sensitivity changes after exercise and lumbar muscle performance in individuals with chronic low back pain (LBP). This study will consist of three specific aims. Aim 1 examines changes in local exercise-induced hypoalgesia. Aim 2 will assess changes in lumbar multifidus and erector spinae thickness using ultrasound imaging before and after the intervention. Aim 3 will evaluate changes in lumbar extensor strength (handheld dynamometry (HHD)) and endurance (Biering-Sørensen test).
NCT05660512
This is an independent prospective, noninterventional, observational post-market data collection of the patient-reported effectiveness, ongoing safety and satisfaction outcomes for patients treated with the Intracept Procedure at a single study site.
NCT07524686
Low back pain with lumbar radiculopathy is a common condition that significantly affects functional ability and quality of life. Manual therapy is widely used as a first-line treatment to reduce pain and improve mobility. This study aims to compare the effectiveness of spinal mobilization with leg movement (SMWLM) and neurodynamic mobilization in patients with lumbar radiculopathy. A total of 20 participants were randomly assigned into two groups. One group received SMWLM, while the other group received neurodynamic mobilization of the sciatic nerve over a treatment period of six weeks. Outcomes included pain intensity, quality of life, and hip range of motion. The results of this study aim to identify the more effective intervention for improving clinical outcomes in patients with lumbar radiculopathy.
NCT07524010
Low back pain is a highly prevalent musculoskeletal condition and is frequently associated with structural and functional alterations of the lumbar multifidus muscle. Percutaneous electrolysis is an ultrasound-guided invasive physiotherapy technique increasingly used in the management of musculoskeletal pain; however, its underlying biological mechanisms remain poorly understood. The aim of this study is to investigate the biochemical and molecular effects of percutaneous electrolysis applied to the lumbar multifidus muscle in patients with low back pain. A multidisciplinary, blood-based multi-omics approach will be used to explore systemic biochemical changes induced by the intervention. In this preliminary controlled study, blood samples will be collected from participants before and after treatment and analyzed using proteomic and lipidomic techniques. Multivariate statistical and bioinformatic analyses will be performed to identify proteins, lipids, and metabolic pathways that are significantly modulated by percutaneous electrolysis compared with a control procedure. The results of this study are expected to contribute to a better understanding of the physiological and biochemical mechanisms of action of percutaneous electrolysis and to support the identification of potential blood biomarkers associated with its therapeutic effects in low back pain.
NCT06518278
BACKGROUND: Chronic pain continues for more than 12 weeks despite medication or treatment. Chronic pain is the main symptom of muscle and joint problems, rarely explained by damage to the muscle and joints alone. Activity in the central nervous system (CNS; nerves, spinal cord, and brain) pathways governs our ability to describe pain intensity and our emotional response to pain. Musculoskeletal conditions (e.g., inflammatory arthritis, osteoarthritis, low back pain, fibromyalgia) share altered CNS pathways, acknowledged by recent classifications of 'primary' and 'nociplastic' pain. Clinically useful tools to diagnose and measure activity and reveal abnormalities in these CNS pathways are needed to improve clinical decisions and accelerate new treatment development. Laboratory pain sensitivity testing and brain imaging confirm the CNS as a primary contributor to pain. These assessments are less acceptable or unfeasible for clinical practice. Simpler clinical pain sensitivity assessments are being developed. The investigators simple Central Aspects of Pain (CAP) questionnaire detects some people with pain sensitivity and knee, rheumatoid arthritis or low back pain. Combining the CAP questionnaire reflecting emotional processing and simpler pain sensitivity assessment, combining two different dimensions should be better than either approach alone. PURPOSE: To optimise diagnosis and measurement of CNS as the primary contribution to chronic musculoskeletal pain by using the CAP questionnaire and simpler pain sensitivity assessments to ensure timely, effective diagnosis and treatment. OBJECTIVES: 1. Assess the ease, ability and performance of the combined CAP questionnaire and simpler pain sensitivity assessments to identify CNS as the primary contributor to chronic pain across musculoskeletal conditions. 2\. Use the CAP questionnaire alone or with substitute measures of activity in CNS pathways, demographic, and clinical variables to indicate pain levels at six and twelve weeks. 3\. Understand the relationship between CAP and simpler pain sensitivity assessment with laboratory pain sensitivity assessments as a tool to inform the current CNS activity contributing to pain. 4\. Evaluate associations between the CAP questionnaire and simpler pain sensitivity assessments with patient outcomes.
NCT06135142
Objective This study aimed to compare the effects of connective tissue massage and classical massage on pain, functional status and quality of life in patients with chronic non-specific low back pain. Methods The study included 30 participants diagnosed with chronic non-specific low back pain. Participants were randomly divided into three groups: classical massage (n=10), connective tissue massage (n=10), and control groups (n=10). The control group received standart physical therapy only. All interventions were administered over a period of 3 days per week for 4 weeks, with each session lasting approximately 15-20 minutes. All assessments were performed at baseline and at the end of 4 weeks. For all participants, the severity of pain was assessed using the Visual Analog Scale, the level of impaired function was measured using the Functional Low Back Pain Scale, lumbar mobility was evaluated with the Modified Schober Test and Sit and Reach Test, physical disabilities were gauged using the Roland Morris Disability Questionnaire, and the quality of life was assessed using the Short Form-36 Quality of Life questionnaire.
NCT07282925
The goal of this clinical trial is to compare Cognitive Functional Therapy (CFT) with Kinetic Control Training (KCT) in participants with non-specific low back pain. The study wants to see which approach helps lower pain, reduce disability and improve movement control. The main questions it aims to answer is * Is there difference between Cognitive Functional Therapy and Kinetic control training on pain intensity, disability and movement control in participants with Non Specific Low Back Pain? * Is there difference between Cognitive Functional Therapy and Kinetic control training on pain catastrophizing and self-efficacy in participants with Non Specific Low Back Pain? Researcher will compare the both CFT and KCT group to see if one treatment is superior to other in treating participants with non-specific back pain. Participants will * Attend treatment sessions based on the group they are placed in. * Take session three times each week for eight weeks. * They will be asked short questions about their pain, daily activity, and movement throughout the study.
NCT07480759
his randomized clinical trial aims to compare the effects of low-load blood flow restriction (LL-BFR) training and traditional heavy-load resistance training (HL-RT) on male athletes with sub-acute non-specific low back pain. Participants will be randomly assigned to either the LL-BFR or HL-RT group for a specified intervention period. Both groups will perform supervised exercise sessions targeting core and lumbar stabilizing muscles. Outcomes including pain intensity, functional disability, and muscle strength will be assessed at baseline and post-intervention. The study seeks to determine whether LL-BFR can provide comparable or superior benefits to HL-RT while reducing mechanical stress on the lumbar spine.
NCT07484542
The aim of this study is to find the effects of retro walking along with core stabilization on pain, disability and balance in non-specific chronic low back pain patients. Randomized controlled trials will be done at Railway general hospital, Rawalpindi and Care plus medical center, Islamabad. The sample size was 42. The subjects were divided in two groups, 21 subjects in group A will undergo retro-walking along with core stabilization and 21 in group B will undergo only core stabilization exercises. Conventional physical therapy protocol will apply to both groups. Sampling technique applied was purposive nonprobability sampling technique. Only 25-40 years individual with chronic low back pain were included. Tools used in the study are visual analogue scale, Oswestry Disability Index and G\&B app. Data will be analyzed through Statistical Package for the Social Sciences version 21.