[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-low-back-pain\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-low-back-pain":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,52,74,106,138,175],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":34,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100465768","high-frequency-rf-current-effects-on-muscle-pain-and-function-100465768",false,"NCT05345015","High Frequency RF Current Effects on Muscle Pain and Function","Acute and Chronic Effects of High Frequency RF Electrical Current on Pain and Muscle Function in Individuals With Musculoskeletal Pain","Individuals with Muscle Injury\n\nInclusion Criteria:\n\n* Age over 18 years.\n* Athletes: amateur soccer players or sprinters with regular, systematic training.\n* Suspected Grade I or II hamstring strain.\n* Cessation of training due to injury.\n* No surgical intervention in the previous year (for initial assessment as potential participants).\n\nExclusion Criteria:\n\n* History of injury to the same muscle (ipsilateral side) within the last 6 months.\n* Other injury to the posterior aspect of the thigh.\n* Other injuries or chronic pain in the trunk or lower limbs.\n* Use of non-steroidal anti-inflammatory drugs (NSAIDs) in the 3 months prior to the injury.\n\nIndividuals with Acute Low Back Pain\n\nInclusion Criteria:\n\n* Age over 18 years.\n* Pain located between the lower ribs and the gluteal folds (top of the buttocks).\n* Pain occurred on fewer than half of the days over the preceding six months.\n* Pain intensity $\\\\ge$ 6\u002F10 on the Visual Analogue Scale (VAS).\n* Pain related to one or more of the following:\n\n  * Lumbar facet joints\n  * Sacroiliac joints\n  * Lumbar intervertebral discs\n  * Muscles, tendons, or ligaments of the lumbar and sacral region\n  * Other bony structures of the lumbar spine\n* Discontinuation of non-steroidal anti-inflammatory drugs (NSAIDs) or analgesics:\n\n  * 1 day prior to measurement\n  * 48 hours after measurement\n\nExclusion Criteria:\n\n* Radiographic evidence of inflammatory disease affecting the spine.\n* Spinal fracture.\n* Significant genetic structural abnormality of the spine.\n* Pregnancy.\n* Psychiatric disorders.\n* Receipt of systemic medication or treatment in the last 3 months.\n* Presence of neurological deficits (sensory, motor, or reflexes).\n* Receipt of TENS or TECAR therapy within the last year.\n\nIndividuals with Chronic Low Back Pain\n\nInclusion Criteria:\n\n* Episodes of low back pain (between the lower rib margin and the gluteal fold) for at least half of the days during the last 6 months.\n* Pain intensity $\\\\ge$ 20% on the Visual Analogue Scale (VAS).\n\nExclusion Criteria:\n\n* Spinal stenosis.\n* Radiographic evidence of inflammatory disease affecting the spine.\n* Vertebral fracture.\n* Presence of spondylolisthesis or spondylolytic lesion (spondylolysis).\n* Significant genetic structural abnormality of the spine.\n* Daily, severe low back pain.\n* Pregnancy.\n* Use of medications that might influence heart rate or blood pressure.\n* Psychiatric disorders.","ALL","18 Years","65 Years",{"count":20,"type":21},200,"ESTIMATED","INTERVENTIONAL",[24],"NA","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).",[27,28,29,30,31,32,33],"Transcutaneous Electric Nerve Stimulation","Chronic Low-back Pain","Hamstring Injury","Muscle; Injury, Quadriceps (Thigh)","Physical Therapy","Calf Muscle Pulled","Acute Low Back Pain",[35,36,37,38],"Sport injuries","TECAR therapy","Low back pain","Muscle injury","RECRUITING","2026-06-23",{"date":42,"type":43},"2026-06-26","ACTUAL",{"date":45,"type":43},"2022-09-01",{"date":47,"type":21},"2029-12-31",{"name":49,"class":50},"Aristotle University Of Thessaloniki","OTHER",2,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100614278","the-effect-of-integrating-pain-neuroscience-educationpne-with-conventional-physiotherapy-on-pain-and-functional-disability-in-patients-with-acute-low-back-pain-100614278","NCT07277517","The Effect of Integrating Pain Neuroscience Education(PNE) With Conventional Physiotherapy on Pain and Functional Disability in Patients With Acute Low Back Pain","Inclusion Criteria:\n\n* Adults aged 18 years and older.\n* A primary complaint of acute low back pain (defined as pain between the bottom of the ribs and the gluteal fold), with or without leg pain.\n* Pain duration of less than 6 weeks.\n* Absence of any \"red flags\" for serious spinal pathology (e.g., tumor, infection, fracture, cauda equina syndrome), as confirmed by an orthopedist or neurologist.\n\nExclusion Criteria:\n\n* Low back pain lasting more than 3 months (chronic low back pain).\n* History of spinal surgery within the past 3 years.\n* Inability to read or understand Persian.\n* Diagnosed cognitive impairments.\n* Unwillingness to continue the treatment or study protocol.\n* Diagnosed rheumatic, neurological, cardiac, metabolic, or respiratory diseases.\n* Diagnosis of fibromyalgia, chronic fatigue syndrome, loss of skin sensation, or skin inflammation\u002Fswelling in the low back area.\n* Presence or emergence of any \"red flag\" condition.\n* Missing more than 3 consecutive treatment sessions.\n* Previous participation in Pain Neuroscience Education sessions.",{"count":59,"type":21},48,[24],"Acute low back pain is one of the most common health problems in the world. Most people experience it at least once in their lives, and although many cases improve within a few weeks, a significant number of patients continue to struggle with pain, fear of movement, stress, and reduced daily function. These psychological factors-such as catastrophizing (\"my back is damaged\"), fear of movement (\"if I move, it gets worse\"), and avoidance behaviors-can slow recovery and increase the risk of the pain becoming chronic.\n\nPain Neuroscience Education (PNE) is a modern educational approach that teaches patients how pain actually works in the nervous system. Instead of focusing only on muscles and bones, PNE helps people understand how the brain interprets pain, why pain can persist even without serious injury, and how thoughts, emotions, and behaviors can influence the experience of pain. Research shows that PNE can reduce fear, improve movement, and help people participate better in rehabilitation-especially in chronic pain. However, there is very limited high-quality evidence about its effects in acute low back pain.\n\nThe purpose of this study is to determine whether adding Pain Neuroscience Education to routine physiotherapy can improve recovery in people with acute low back pain.\n\nTo do this, the investigators will conduct a single-blind randomized clinical trial with two groups of patients:\n\nControl group: Receives conventional physiotherapy, including soft-tissue mobilization and TENS, along with routine patient education about posture and back care.\n\nIntervention group: Receives the same physiotherapy plus two structured sessions of Pain Neuroscience Education, delivered individually using simple explanations, metaphors, and visual materials.\n\nBoth groups will receive eight treatment sessions over four weeks.\n\nThe investigators will measure several important outcomes before starting treatment and immediately after the 8th session, including:\n\nPain intensity\n\nFunctional disability\n\nPain catastrophizing\n\nFear-avoidance beliefs\n\nFear of movement (kinesiophobia)\n\nThe investigators' hypothesis is that patients who receive PNE in addition to routine physiotherapy will show greater reductions in pain, disability, fear, and catastrophizing compared to those receiving physiotherapy alone.\n\nIf proven effective, this approach could provide a simple, low-cost, and safe addition to physiotherapy that not only reduces pain but also prevents acute low back pain from turning into a chronic condition. This could help improve patients' quality of life and reduce the economic and healthcare burden caused by low back pain.",[63],"Acute Low-back Pain","2026-03-30",{"date":66,"type":43},"2026-04-03",{"date":68,"type":43},"2025-10-05",{"date":70,"type":21},"2026-08",{"name":72,"class":50},"Iran University of Medical Sciences",1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":16,"minAge":17,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":73},"100578967","physical-exam-static--dynamic-ultrasound-assessment--treatment-of-thoracolumbar-fascia-tlf-mediated-low-back-pain-100578967","NCT06818175","Physical Exam, Static & Dynamic Ultrasound Assessment, & Treatment of Thoracolumbar Fascia (TLF) Mediated Low Back Pain","Machine Learning Analysis of Ultrasound Images for the Investigation of Thoracolumbar Myofascial Pain and Therapeutic Efficacy of Hydrodissection (DoD) and Osteopathic Manipulative Treatment (AOA) for Thoracolumbar Fascia Glide Impairment","Inclusion Criteria:\n\n* ALL 18-50 year olds with No Low Back Pain (LBP); Acute LBP (\\\u003C 3 months); or Chronic LBP (\\> 3 months)\n\nExclusion Criteria:\n\n* Allergy to ultrasound gel - relative, consider alternatives\n* BMI: \\> 30\n* Pregnancy or Breastfeeding: current or remote, within the past 6 months\n* Spinal Surgery: history of lower thoracic or lumbar spine: within the past year, of more than a single level of hardware. (prior single level microdiscectomy, laminectomy, or fusion, that is stable for 1 year or greater is NOT excluded)\n* Current Low Back Pain (LBP) or Injury: severe enough to 1) limits activities of daily living, 2) limits the ability to work to less than an 8-hour day, 3) unable to lie prone with a pillow under their abdomen\u002Fpelvis for 30-45 minute intervals\n* History of Spinal Pathology: ankylosing spondylitis, rheumatoid arthritis or other rheumatic diseases, spinal tumor, or spinal infection\n* Corticosteroids: Injections into the low back or systemic medication within the last 3 months. Must be able to cease injections and\u002For corticosteroid medication during the study\n* Medication Usage that cannot be discontinued for length study: anticoagulants, muscle relaxants\n* Physical or Manual Therapy Interventions: in the last 90 days: physical therapy, acupuncture or trigger point therapy, any type of manual medicine or other bodywork treatments",true,"50 Years",{"count":20,"type":21},[24],"This Study is for our continued study of the Thoracolumbar Fascia (TFL) in patients with and without low back pain by our experienced multidisciplinary team:\n\nVincent Wang PhD, VT Biomedical Engineering \\& Mechanics (BEAM). Albert J Kozar DO, FAOASM, R-MSK. P. Gunnar Brolinson, DO, FAOASM, FAOCFP. David T. Redden PhD, VCOM Research Biostatistician. Matthew Chung DO, VCOM and Team Physician at Virginia Tech. Edward Magalhaes, PhD, LPC, Psychiatry and Neuro- Behavioral Sciences, VCOM.\n\nThis listing is specifically for our renewed efforts via two, Department of Defense (DoD) and American Osteopathic Association (AOA), extramurally, simultaneously funded grants for similar but distinct projects. Both funding sources are aware of each other's funding and have approved their grant study moving forward simultaneously with some integration.\n\nDoD: Machine Learning Analysis of Ultrasound Images for the Investigation of Thoracolumbar Myofascial Pain and Therapeutic Efficacy of Hydrodissection.\n\nThe primary objectives of the proposed project are to:\n\n1. develop reliable, quantitative image analysis approaches to objectively distinguish images from subjects with acute or chronic TLF pain from those without pain and\n2. to assess the preliminary clinical efficacy of hydrodissection of the TLF as a novel therapeutic treatment for chronic LBP.\n\nAOA: Assessment of the Therapeutic Efficacy of OMT on Chronic Low Back Pain: An Integrated Sonographic and Machine Learning Analysis of Thoracolumbar Fascia Glide Impairment.\n\nThe primary objectives of the proposed project are to:\n\n1. assess the preliminary clinical efficacy of OMT as a therapeutic treatment for CLBP of TLF origin and\n2. develop reliable, quantitative image analysis approaches to objectively distinguish images from subjects with TLF pain from those without pain.\n\nThese projects will share 50 no LBP subjects as controls. The DOD study will include 50 acute LBP and 50 CLBP. The AOA study will include 50 CLBP.\n\nThis project uses standard surveys, physical exam, functional tests, and ultrasound imaging to obtain both static images of the TLF at multiple transition zones. It further uses ultrasound to evaluate the dynamic gliding motion, via cine loops, of this fascia in 2 different body movements in subjects with acute low back pain (ALBP), with chronic low back pain (CLBP), and without low back pain (WLBP). All images will be clinically analyzed and further assessed by textural and machine learning analysis. Patients with CLBP (only) will choose to enter one of the two studies (DoD vs AOA) at the time of consent.\n\nAll images will be clinically analyzed and further assessed by textural and machine learning analysis. Patients with CLBP (only) that are found to have TLF glide impairment or positive physical exam maneuvers suggesting TLF as etiology will enter the treatment arm of the chosen study at the time of consent, either ultrasound guided hydrodissection (USGH), or Osteopathic Manipulative Therapy (OMT). After receiving 3 treatments utilizing one of these modalities, the CLBP participants will have repeat standard surveys, physical exam, functional tests, and ultrasound imaging assessments at 2,4,6,12, and 24 weeks post-treatment.\n\nAt the conclusion of this project, the investigators expect to have developed, refined, and implemented robust and feasible experimental and computational approaches which can be further expanded in larger-scale studies. The development of our data-driven computer models for the objective analysis of sonographic images of the TLF has high potential impact as it seeks to transform the assessment of TLF integrity, injury and healing via establishment of reliable US imaging biomarkers. The investigators anticipate that the tools developed will have broad utility to assess a variety of clinical treatments for the TLF. The investigators also hope to validate physical exam maneuvers that may predict TLF mediated LBP and have preliminary evidence of the efficacy of hydrodissection and OMT in TLF mediated LBP.\n\nIn pursuit of these objectives, the investigators will adopt an innovative approach featuring a robust integration of clinical imaging, physical exam, pain and functional outcomes, quantitative image analysis, and machine learning analyses.\n\nSpecific Aim 1: Compare sonographic TLF imaging characteristics in individuals with acute versus chronic pain to those without low back pain.\n\nSpecific Aim 2: Develop a machine learning (ML) classification algorithm to reliably distinguish abnormal myofascial tissue in acute versus chronic pain stages from healthy tissue.\n\nSpecific Aim 3:\n\nDoD Study: Assess the preliminary therapeutic efficacy of hydrodissection as a novel treatment for TLF pain using quantitative US imaging and ML tools.\n\nAOA Study: Assess the preliminary therapeutic efficacy of OMT as a treatment for CLBP using quantitative US imaging and ML tools.",[87,28,33],"Low Back Pain",[89,90,91,92,93,94,95,96],"Diagnostic Ultrasound","Machine Learning","Shear Wave Elastography","Osteopathic Manipulative Treatment (OMT)","Hydrodissection","Physical Exam","Fascia","Thoracolumbar Fascia","2026-03-11",{"date":99,"type":43},"2026-03-13",{"date":101,"type":43},"2023-09-01",{"date":103,"type":21},"2026-12-31",{"name":105,"class":50},"Edward Via Virginia College of Osteopathic Medicine",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":114,"phases":4,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":4},"100606537","exploring-multidimensional-trajectories-in-people-with-low-back-pain-100606537","NCT07176845","Exploring Multidimensional Trajectories in People With Low Back Pain","Inclusion Criteria:\n\n* have low back pain (rate their LBP with an intensity of \\>0 on a 0-10 numerical pain rating scale at enrollment)\n* 18 years old or older\n* be proficient in German, French, or English\n* own a smartphone that is able to run either Android or iOS (iPhone) apps\n* own a smartphone that includes accelerometer and gyroscope sensors\n\nExclusion Criteria:\n\n* diagnosis of a specific LBP etiology (e.g. fracture, tumoral process, radiculopathy with evidence of neurological deficit or cauda equina)\n* history of previous spinal fusion surgery, which would influence on motor behavior\n* presence of any other medical conditions (pathologies, diseases, comorbidities, injuries, surgeries or painful conditions) that could jeopardize the patients' safety, prevent them from performing the spinal motion measurements safely (e.g., risk of falls due to frailty), or influence spinal motion (e.g., Parkinson's disease, stroke)\n* inability to follow procedures\n* inability to give consent (e.g. dementia)\n* owner of a smartphone, not able to run an Android or iPhone application\n* owner of a smartphone without accelerometer and gyroscope sensors",{"count":113,"type":21},600,"OBSERVATIONAL","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.\n\nLBP 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.\n\nThis 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.\n\nEstablished 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.",[33,117],"Chronic Low Back Pain (CLBP)",[119,120,121,122,123,124,125,126,127],"low back pain","LBP","spinal motion","spine","disability","motor behavior","physical activity","pain-related fear","psychological factors","NOT_YET_RECRUITING","2025-09-12",{"date":131,"type":43},"2025-09-16",{"date":133,"type":21},"2025-09-15",{"date":135,"type":21},"2028-05-31",{"name":137,"class":50},"Bern University of Applied Sciences",{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":146,"enrollmentInfo":147,"targetDuration":4,"studyType":114,"phases":4,"briefSummary":149,"conditions":150,"keywords":159,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":51},"100590434","multimodal-imaging-and-biospecimen-collection-for-low-back-pain-lbpb-100590434","NCT06967363","Multimodal Imaging and Biospecimen Collection for Low Back Pain (LBPB)","Multi-modality Imaging and Collection of Biospecimen Samples in Understanding Brain Function in Low Back Pain Patients: a Longitudinal Cohort Study","LBPB","Inclusion Criteria:\n\n1. Adults aged 18 to 80 years.\n2. Diagnosis of low back pain, defined as pain located between the lower costal margins and the gluteal folds, with or without leg pain.\n3. Eligible for surgical or non-surgical treatments.\n4. Willingness to undergo neuroimaging (fMRI), microbiota sampling, psychological assessments, and other related study procedures. Ability to provide written informed consent.\n\nExclusion Criteria:\n\n1. Severe neurological deficits requiring emergency surgery.\n2. Antibiotic or probiotic use within the past 4 weeks. Suffering from digestive diseases such as irritable bowel syndrome, gastric ulcer, duodenal ulcer, etc.;\n3. Diagnosed spinal infections, tumors, fractures, or inflammatory diseases (e.g., ankylosing spondylitis).\n4. Known severe psychiatric disorders (e.g., schizophrenia, bipolar disorder) that would interfere with study participation.Head trauma; history of substance abuse.\n5. Contraindications to MRI scanning (e.g., pacemaker, metallic implants, severe claustrophobia).\n6. Pregnant or breastfeeding women.\n7. Participation in another interventional clinical trial within the past 3 months.\n8. Working at night shifts or travelling across time zones in the past 6 months.\n9. Excessive consumption of coffee, tea.","85 Years",{"count":148,"type":21},360,"This prospective cohort study investigates the neurobiological, genetic, and psychosocial mechanisms underlying acute and chronic low back pain (LBP). Core objectives include establishing a high-quality biobank to support future research in connectomics, genomics, and biomarker discovery, and identifying predictors of pain progression and treatment response.\n\nThe study will also assess the impact of comorbid conditions such as anxiety, depression, and sleep disturbances on pain perception and clinical outcomes. Longitudinal analyses will explore the dynamic interplay between emotion, cognition, sleep, and pain to inform precision, mechanism-based interventions.\n\nFunctional imaging will be used to examine brain responses to nociceptive modulation, aiming to identify neural circuits involved in pain chronification. By integrating multimodal data-including neuroimaging, neurophysiology, microbiota profiling, polysomnography, and molecular assays-the study will define LBP subtypes, with a particular focus on nociceptive, neuropathic, and nociplastic mechanisms. The ultimate goal is to establish prognostic biomarkers and advance personalized strategies for LBP prevention and treatment.",[117,33,87,151,152,153,154,155,156,157,158],"Chronic Pain","Acute Pain","Mental Disorders","Sleep Disorder","Fibromyalgia (FM)","Nociplastic Pain","Neuropathic Pain","Nonspecific Low Back Pain",[160,161,162,163,164,165],"chronic low pack pain","fMRI","brain function","microbiota","nociplastic pain","treatment","2025-05-02",{"date":168,"type":43},"2025-05-13",{"date":170,"type":21},"2025-05-15",{"date":172,"type":21},"2028-12-31",{"name":174,"class":50},"Peking University Third Hospital",{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":81,"sex":181,"minAge":17,"maxAge":182,"enrollmentInfo":183,"targetDuration":4,"studyType":22,"phases":185,"briefSummary":186,"conditions":187,"keywords":4,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":73},"100588689","the-palliative-effect-of-tens-waa-on-capsaicinheat-induced-acute-lower-back-pain-a-self-controlled-clinical-study-100588689","NCT06944665","The Palliative Effect of TENS-WAA on 'Capsaicin\u002FHeat' Induced Acute Lower Back Pain: a Self-controlled Clinical Study","Inclusion Criteria:\n\n* Healthy adult males between the ages of 18-44 years;\n* The dominant hand is the right hand;\n* No persistent pain in the last month;\n* No acute pain in the last week;\n* Good health with no medical condition for which he\u002Fshe is receiving treatment;\n* Subjects agreed to participate in this trial and signed an informed consent form.\n\nExclusion Criteria:\n\n* With malignant tumours and serious heart, liver and kidney diseases;\n* Those with skin breakage at the site of capsaicin application;\n* Those with a history of lumbar spine surgery, spinal fracture, rheumatic disease, cancer, pacemaker, or congenital anomalies of the spine;\n* Any other medical condition that may affect pain perception, including neurological and psychiatric disorders;\n* Taking sedative and sleep-aiding drugs within one week;\n* Those who are allergic to capsaicin;\n* Currently participating in another clinical trial concerning lower back pain or pain.","MALE","44 Years",{"count":184,"type":21},30,[24],"Acute lower back pain is a common condition that occurs in all age groups, and most people will experience acute lower back pain at least once in their lives. The use of pharmacological analgesic interventions may result in complications such as gastrointestinal reactions, skin reactions, and renal damage, so there is an urgent need for an analgesic method that is easy to use, relatively safe, and has no significant systemic side effects to alleviate patients' pain.\n\nWrist and ankle acupuncture is an acupuncture therapy developed by Professor Zhang Xinshu and other professors of the First Affiliated Hospital of the Second Military Medical University of the Chinese People's Liberation Army based on the meridian theory of Chinese medicine, by dividing the human body into two segments and six zones and treating them according to the longitudinal zones in which the illnesses are located or the corresponding points of the areas where the primary lesions are located, in order to achieve the purpose of dredging the meridians and collaterals, regulating qi and blood, balancing the yin and yang, relieving pain and treating the illnesses, and it has been widely used for treating the clinical It is widely used to treat all kinds of pain and neurological diseases.\n\nTranscutaneous Electrical Nerve Stimulation is a non-invasive pain treatment method, which relieves pain by distributing current of specific frequency and intensity to stimulate peripheral nerves. In recent years, our team has combined the wrist and ankle needles with transcutaneous electrical nerve stimulation to develop an analgesic device that can be worn on the human wrist and ankle, which is called transcutaneous electrical nerve stimulation based on the theory of wrist and ankle needles. Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture theory（TENS-WAA) uses low-frequency electronic pulses to stimulate the entry point of the wrist-ankle acupuncture needle, which has the advantages of easy to wear, concentrated treatment site, safe treatment, and needle-free.\n\nFunctional near-infrared spectroscopy is a novel optical technique for non-invasive brain activity measurement by reading cerebral haemodynamics and oxygen saturation. Advantages include portability, non-invasiveness, no ionising radiation or drug injections, and simultaneous measurement of two haemodynamic parameters - deoxyhaemoglobin and oxyhaemoglobin. Several studies have demonstrated the utility and potential of functional NIR spectroscopy for pain assessment.\n\nIn medical research, the capsaicin model is widely used to simulate acute pain in humans, and capsaicin-induced pain sensations are produced primarily through binding to capsaicin receptors. Topical application of capsaicin activates TRPV1, located at the end of primary sensory neurons in the trunk and viscera, which, through a series of actions, leads to the release of pro-inflammatory factors, while injury receptors in the skin then generate neural signals that are transferred to the cerebral cortex, resulting in the sensation of pain. The sensation is similar to neuropathic pain, and pro-inflammatory factors also play a key role in the pathophysiological process of acute lower back pain. Therefore, the use of capsaicin is effective in inducing acute lower back pain, while related studies have shown that the combination of heat and capsaicin has a synergistic or additive effect.\n\nThe present study was designed as an autocross-control study in which a 'capsaicin-thermal pain' low back model was established in healthy subjects to induce acute lower back pain, and the analgesic efficacy of TENS-WAA was verified by using the fNIRS, VAS, and other assessment methods, with the following main objectives:\n\n1. To repeat the validity of the pre-cortical fNIRS pain assessment paradigm in a controlled study;\n2. To validate the efficacy of the Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture theory intervention in an autocross-control study by using fNIRS to collect data on changes in blood oxygen levels in brain regions involved in pain perception (frontal pole area and dorsolateral prefrontal cortex), as well as the VAS;\n3. Explore the specificity of Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture theory acupoints through the self-randomised crossover control of 'unilateral pain + ipsilateral intervention' and 'unilateral pain + contralateral intervention'.",[33],"2025-04-17",{"date":190,"type":43},"2025-04-25",{"date":192,"type":21},"2025-05-05",{"date":194,"type":21},"2026-01-31",{"name":196,"class":50},"Xiaonan Huang"]