Clinical Research Directory

Pilot Study of Vagal Stimulation in Chronic Low Back Pain

Low back pain is a major public health problem. It is the leading cause of disability in the world. The factors that lead to chronicity of low back pain are multi-factorial and are essentially represented by psychosocial factors (catastrophism, kinesiophobia, algophobia job dissatisfaction, emotional problems such as depression, anxiety, stress, injustice, etc.). Pain is a multimodal experience that involves different brain structures that are activated by the pain signal and involve the autonomic nervous system (ANS). The vagus nerve is the main actor of one of the two branches of the ANS, the parasympathetic system, which acts as a "slow-down". The vagus nerve participates in the inter-neuronal transmission of key neurotransmitters for mood, alertness, attention and motivation. Vagal stimulation has been used for many years as an analgesic device in chronic pain (vascular pain (facial vascular pain, fibromyalgia, visceral pain, gastrointestinal and pelvic pain...) To date, no study has been conducted on the value of vagal stimulation in chronic low back pain.

Assessment of the Evolution of Lumbar Spine Movement Fluidity Using Xsens Inertial Sensors in Subjects With Chronic Low Back Pain Before and After Rehabilitation

Low back pain, defined as pain located between the thoracolumbar junction and the lower gluteal fold, becomes chronic in 8% of patients. As the leading cause of disability worldwide, it has major individual and medico-economic consequences. Three-dimensional biomechanical analysis allows exploration of movement alterations related to low back pain. Although several parameters have already been studied (maximum joint range of motion (ROM), lumbopelvic rhythm, movement variability, gait), no consistent kinematic profile has emerged. Movement fluidity, assessed by the presence of jerks (brief movement disturbances), remains under-described despite its relevance in evaluating movement quality. Invistigators hypothesize that lumbar spine movement fluidity during flexion improves after a rehabilitation program and correlates with clinical response. This project stands out by exploring a rarely studied parameter (movement fluidity) and integrating it as a potential indicator for rehabilitation monitoring.

Acute Low Back Pain. Topical Diclofenac and Oral Ibuprofen.

This is a randomized, double-blind placebo-controlled study comparing two different treatments for acute low back pain: oral ibuprofen and topical diclofenac. Participants will be randomized to one of three study arms: 1) Oral ibuprofen + topical diclofenac; 2) Oral ibuprofen + topical placebo; 3) Oral placebo + topical diclofenac. Outcomes will be determined at 48 hours (2 days) and 7 days later.

Wearable Spine Assessment in Adults With and Without Low Back or Neck Pain

This is a single-site, prospective, observational, single-visit feasibility and validity study. Adult participants with and without low back or neck pain will be screened, consented, and enrolled to undergo a structured wearable-sensor-based spine assessment in a single on-site visit. Approximately 20 participants will be enrolled at a single site: * Approximately 10 adults with self-reported chronic or subacute low back or neck pain (LBP/Neck Pain group) * Approximately 10 adults without current back or neck pain (Control group) The AxiSens battery includes the Fingertip-to-Floor (FTF) test for lumbar flexion, the Chin-to-Chest (CTC) test for cervical flexion, a seated Trunk Stability Test on an unstable surface, the Cervical Flexor Endurance Test, the five-times sit-to-stand F5xSTS) test, and a brief functional task module covering overhead and forward reach. To support intra-rater repeatability characterization, the AxiSens wearable assessment is performed twice within the same visit by a single trained operator, with sensor doffing and re-donning between the two assessments. A short rest interval is provided between the two assessments. Following the on-site assessment, participants complete a brief end-of-session usability and tolerability questionnaire and the Technology Acceptance Model (TAM) questionnaire.

Evaluation of the Japet.W+ Medical Device for Low Back Pain Management

The JAPET.W+ medical device is a new dynamic distraction support system. It could be considered as a new solution in the therapeutic arsenal for managing common low back pain. This study aims to assess the effectiveness of this device among the two targeted populations during daily use. Each patient will be asked to estimate the intensity of their low back pain several times during the clinical investigation. Our main hypothesis is a reduction in low back pain while wearing the device. The secondary hypothesis is a decrease in activity limitations, an increase in participation, an improvement in quality of life, and a reduction in healthcare product and medication consumption.

A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Chronic Low Back Pain

The main purpose of this study is to test the safety and efficacy of study drug for the treatment of chronic low back pain (CLBP). This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292), which is a protocol to accelerate the development of new treatments for chronic pain.

Neuroscience Education and Spinal Manipulation on Health Locus of Control in Low Back Pain

The purpose of this study is to evaluate the effects of combining Pain Neuroscience Education (PNE) with spinal manipulation for individuals suffering from chronic low back pain. Participants will be randomly assigned to one of two groups: one group will receive the combined intervention (neuroscience education plus spinal manipulation), while the control group will receive spinal manipulation alone. The primary goal of the researchers is to investigate whether this combined approach can help patients change their health locus of control-shifting from an external belief (that their health depends on external factors or clinicians) to an internal belief (that they have control over their own recovery and pain management). The total study period will last 3 months, consisting of 4 weeks of intervention followed by an 8-week follow-up period to assess long-term changes in pain intensity, disability, and health beliefs.

Managing Pain Using Optimized Sequences by Adjusting Parameters With Independent Current Control

Study to evaluate the effectiveness of time variant pulse (TVP)-SCS in patients with chronic pain using commercially approved Boston Scientific SCS Systems per local Instructions for use (IFU). In addition, to compile real-world clinical outcomes in subjects with chronic, intractable low back and/or leg pain.

Contextual Effects on Inflammatory Biomarkers and Pain Relief After Spinal Joint Manipulation

The goal of this clinical trial is to learn whether contextual effects created by observational learning can change pain relief and inflammation-related biological responses after spinal joint manipulation in adults with chronic non-specific low back pain. The main questions it aims to answer are: Does positive, neutral, or negative observational learning change pain after spinal joint manipulation? Does it change disability, lumbar range of motion, stress, fear of movement, empathy, and treatment expectations? Does it change pressure pain threshold, lumbar tissue temperature, and blood markers related to inflammation, including interleukin-6 (IL-6), high-sensitivity C-reactive protein (hs-CRP), tumor necrosis factor alpha (TNF-α), and interleukin-10 (IL-10)? The researchers will compare 3 groups: a positive expectation group, a neutral group, and a negative expectation group. Before the treatment, each participant will have a short interaction with a trained simulated patient. The simulated patient will present a positive, neutral, or negative experience with spinal manipulation, depending on group assignment. After this, all the participants will receive the same spinal joint manipulation procedure. The participants will: * be randomly assigned to 1 of 3 study groups, * complete baseline questionnaires and clinical tests before treatment, * take part in a brief observational learning session before manipulation, * receive 1 spinal joint manipulation treatment, * complete outcome measurements before treatment, about 60 minutes after treatment, and 24 hours after treatment, * provide blood samples for analysis of inflammation-related biomarkers. This study will include adults aged 18 to 65 years with chronic non-specific low back pain. The main outcome is pain intensity. Secondary outcomes include disability, stress, empathy, fear of movement, lumbar range of motion, tissue temperature, pressure pain threshold, and treatment expectations. Exploratory outcomes include blood biomarkers related to inflammation.

Effect of Lumbar Surgery on Complexity During a Walking Task in Chronic Low Back Pain

Lumbar surgery is the most common treatment for chronic disabling low back pain with degenerative disc disease. There are few elements to objectively evaluate the improvement of the motor control after surgery and the motor adaptation capacities of the patients. The impact of lumbar surgery on complexity in this painful context has never been studied. Theoretically, the restriction of mobility imposed by lumbar surgery should limit the subject's adaptive capacities (of one or more lumbar segments) and thus reduce complexity. Nevertheless, improvement in pain intensity levels could allow the patient to find better motor adaptation capacities, necessary for a positive evolution in the long-term. The aim of this study was to investigate the evolution of gait complexity in chronic low back pain patients pre- and post-surgery. If surgery improves the adaptability of walking through an antalgic benefit exceeding the induced stiffness, the complexity of walking should be superior after surgery. This is a proof-of-concept study in which the study investigators hypothesize that measuring complexity by fractal analysis during a walking task will show the increase in gait complexity induced by lumbar surgery at 3 and 6 months after surgery.

13-year Follow-up of Women With Chronic Low Back Pain in Primary Care - a Prospective Longitudinal Cohort Study

Background: Low back pain (LBP) is among the main causes of long-term sickness absence and is associated with considerable costs for both the individual and society. LBP affects 60-80% of the population and most individuals recover, while about 10-20% develop persistent pain and disability. Women have a higher risk of developing chronic LBP (CLBP) and widespread pain. Purpose: To investigate change in body function, activity, participation and other health related factors in women with CLBP after 13 years and to identify prognostic factors for pain, activity limitation and work ability. Methods: In the present study, all women (n = 131) who were included in the cross-sectional study in 2006 and who were followed-up after 2 years are now invited to the same study-protocol 13 years after the first examination in 2006. The Swedish Ethical Review Authority approved the study. Dnr: 2019-01944, 2019-05-21.

Osteopathic Manipulations of Post Cesarean Section Adhesions on Low Back Pain

Chronic low back pain post cesarean section adhesions represents a restricting dysfunction, mainly influences abdominal fascia that leads to major welfare and economic restrictions. Osteopathic manipulation is a drug-free non-invasive is the therapeutic application of manually guided forces to improve physiologic function and support homeostasis. The purpose of the current study is to determine the effect of osteopathic manipulations of post cesarean section adhesions on low back pain

Effects of Mezieres Method on Muscle Imbalance, Body Awareness and Postural Alignment in Athletes With Lower Back Pain.

The current study is a randomized controlled trial aims to compare the effectiveness of the Mezieres Method combined with core stabilization versus routine physiotherapy involving core stabilization on muscle imbalance, body awareness, and postural alignment in athletes with lower back pain. Eligible participants will be randomly allocated into two groups: an experimental group receiving the Mezieres Method plus core stabilization exercises and a control group receiving routine physiotherapy treatment involving core stabilization alone. Outcomes related to muscle imbalance, body awareness, postural alignment, and pain/function will be assessed before and after the intervention period. The study seeks to determine whether the Mezieres Method combined with core stabilization provides additional benefits in athletes with lower back pain.

The RESET Clinical Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Back Pain

The purpose of this study is to compare standard of care treatments for back pain to electrical stimulation. Stimulation is delivering small amounts of electricity to the nerves in your low back. This study will use a device called the SPRINT Peripheral Nerve Stimulation (PNS) System. The device is cleared by the FDA for up to 60 days of use for the relief of chronic or acute pain (including back pain)

Non-pharmacological Treatment for Pain After Spine Surgery

This study will compare the effectiveness of two pain management pathways (standard vs. enriched) for patients undergoing lumbar spine surgery in the Military Health System (MHS). Effectiveness will be based on post-surgery patient-centered outcomes and extent of opioid use. The study design is a 2-arm, parallel group, individual-randomized trial.

Low Back Pain and Hamstring-to-Quadriceps Strength Ratio in Military Personnel

The aim of this study was to determine the association between low back pain and the strength of knee flexor and extensor muscles in Lithuanian National Defence Volunteer Forces personnel.

Machine-Based Pilates on Quality of Life and Low Back Pain in Older Adults

Chronic low back pain is one of the most prevalent and debilitating conditions among older adults, often compromising physical function and overall quality of life. Structured physical exercise, particularly the Pilates method, is widely recommended for managing this condition. However, existing literature primarily focuses on younger populations using mat-based group classes. This pilot study utilizes an exploratory mixed-methods design to investigate the feasibility and preliminary outcomes of a 12-week individualized, machine-based Classical Pilates program on quality of life and low back pain in active older adults (aged 55 to 75 years). Participants will complete 24 individual sessions (twice a week). The aim is to assess changes in physical domains of quality of life and perceived low back pain intensity, while gathering qualitative contextual insights on body awareness and psychosocial well-being.

Effect of Gluteus Maximus Strengthening on Back Pain, Range Of Motion and Endurance in Desk-Job Workers With Chronic Low Back Pain

The goal of this clinical trial is to learn Effect of strengthening of Gluteus maximum on 40 Desk- Job workers with low back pain and Range of motion he main questions it aims to answer are: 1. Does strengthening of Glutes Maximum decrease the pain in Desk-Job worker with low back pain? 2. 1- Does strengthening of Glutes Maximum increase the Range of Motion in Desk-Job worker with low back pain? Participants will: * treated by: electrotherapy, postural education, active range of motion or Gluteus maximum strengthening. * visit clinic 3 times per weeks for 4 weeks.

Sensorimotor Training With a Mobilized Balance Platform in Patients With Chronic Low Back Pain

This randomized controlled study aims to investigate the effects of a sensorimotor training protocol using a mobilized balance platform device on proprioceptive system function, movement control, balance, physical performance, pain severity, and quality of life in patients with chronic low back pain. A total of 44 patients with chronic low back pain will be recruited from the outpatient clinic of Gaziler Physical Medicine and Rehabilitation Training and Research Hospital. Participants will be randomly assigned to either a sensorimotor training group or a control group. The intervention group will receive sensorimotor training using the Huber 360 balance system, while the control group will perform a home exercise program including stretching, spinal mobility, lumbopelvic control, and balance exercises. Pain severity, proprioception, functional status, balance, physical performance, and quality of life will be assessed before and after treatment by an assessor blinded to group allocation.

Chronic Low Back Pain and Osteopathic Manipulation Treatment

The goal of this clinical trial is to learn if adding Osteopathic Manipulative Therapy (OMT) to the usual medical care provided at the VA (usual VA care) improves treatment outcomes in individuals with chronic low back pain (CLBP). OMT is a set of hands-on techniques a doctor uses to move a patient's muscles and joints which include stretching, gentle pressure, resistance and applying forces to specific areas of the body. This feasibility clinical trial aims to learn about the treatment effects (e.g., effect sizes) of adding OMT to the usual medical care provided at the VA (Usual VA Care) in individuals with LBP.

Comparative Effects Of Post Isometric Relaxation Versus Active Isolated Stretch In Patients With Piriformis Syndrome

The purpose of this study is to evaluate the comparative effects of post-isometric relaxation (PIR) and active isolated stretch (AIS) techniques on reducing pain, improving range of motion, and decreasing functional disability in individuals with piriformis syndrome. A total of 40 participants will be recruited, aged 20-55 yrs, with confirmed piriformis syndrome. Participants will be randomized into two equal groups. Group A (post isometric relaxation) and Group B (active isolated stretch). Both groups will receive Conventional Therapy (Thermotherapy, Electrotherapy). Study variables include: * Independent Variable: Post Isometric Relaxation and Active Isolated Stretching. * Dependent Variables: Pain (measured by Visual Analog Scale), Functional Disability (assessed via Oswestry Disability Index), Range of Motion (assessed via Goniometer). * Control Variables: Age, Gender, BMI, Baseline Pain/ Disability Scores/ROM The intervention will last 2 weeks with 6 sessions (3 sessions per week). Assessments will be conducted at baseline (Week 1, Pre-treatment) and Post every second session. Data will be analyzed to compare immediate and short-term effects of the two interventions. This study aims to provide evidence for targeted manual therapy approaches in priformis syndrome, potentially guiding clinicians toward the most effective technique for pain reduction, improve ROM and decrease functional disability.

Multifidus PET Scan Study

The study involves investigating phenotypic changes (ie metabolic activity in brain pain matrix areas, metabolic activity and textural analysis of multifidus muscle) following multifidus stimulation and establishing relationship with the change in pain, functionality and quality of life.

Common Pain Mechanisms in Migraine, Migraine-Related Neck Pain, and Lower Back Pain: A Cross Sectional Study

Migraine is one of the primary headache disorders with a high prevalence worldwide, leading to significant disability and reduced quality of life. Trigeminal nerve activation and alterations in central pain processing mechanisms play a crucial role in the pathophysiology of migraine. Recent studies suggest that migraine may not only be a headache disorder but also a systemic pain disorder associated with changes in central pain processing mechanisms. Central sensitization is defined as increased sensitivity of nociceptive neurons in the central nervous system to afferent stimuli and is considered a key mechanism in the development and maintenance of chronic pain conditions. This condition is characterized by pain hypersensitivity, allodynia, and generalized pain sensitivity. In addition to headaches, other musculoskeletal pains are also frequently reported in migraine patients. Spinal pain, particularly neck and lower back pain, can occur in migraine sufferers, with central sensitization contributing to the condition, considering the spine as a chain. Large population-based studies have shown a significant association between primary headaches and persistent low back pain, and a higher prevalence of concomitant low back pain has been reported in individuals with chronic migraine and chronic tension-type headaches. This association is suggested to be explained by the shared nociceptive pathways of the head and spinal structures and the changes in central pain processing seen in chronic pain conditions. This relationship between migraine and musculoskeletal pain is also explained by the presence of shared neuroanatomical structures such as the trigemino-cervical complex. Nociceptive afferents from the upper cervical spine and cranial structures converge at the trigemino-cervical complex level in the brainstem, creating a predisposition to the co-occurrence of head and neck pain. This mechanism suggests that pain or dysfunction in the cervical region in migraine patients may be related to headache symptoms. Studies have shown that neck pain is more common in individuals with migraine than in the general population, and research suggests this rate may be approximately 10-12 times higher compared to healthy individuals. Furthermore, it has been reported that individuals with migraine more frequently experience tenderness in cranio-cervical muscles such as the upper trapezius, sternocleidomastoid, and suboccipital muscles, myofascial trigger points, and increased muscle sensitivity. The literature also emphasizes that these cervical symptoms may be related to migraine frequency, attack severity, and headache-related disability. These findings suggest that migraine should be considered not only as a primary headache disorder but also as a complex neurobiological condition associated with widespread pain sensitivity and musculoskeletal symptoms. A better understanding of the relationship between migraine and musculoskeletal pain could be important for developing multidisciplinary treatment approaches. However, clinical studies in the literature that evaluate migraine, accompanying neck pain, and lower back pain together in terms of common pain mechanisms are quite limited. Therefore, the rationale for this study is that examining factors such as central sensitization, pain threshold, pain catastrophizing, psychological factors, body awareness, and regional disability together in migraine patients can lead to a better understanding of the pathophysiology of migraine-related musculoskeletal pain. Based on all these reasons and evidence, the aim of this study is to investigate the possible common pain mechanisms and musculoskeletal pathophysiological processes of migraine-related neck and back pain in migraine patients with accompanying neck and/or back pain by evaluating factors such as central sensitization, pain threshold, pain catastrophizing, psychological factors, body awareness, and regional disability together.

AI-Based Phenome Data Analysis for Predicting the Onset of Major Diseases

This study aims to develop and validate an artificial intelligence (AI)-based predictive model to estimate the risk of incident onset of five major diseases or conditions: cardiovascular disease, type 2 diabetes mellitus, breast cancer, low back pain, and osteoarthritis, in adults aged 30 to 60 years. For each participant, an index date will be defined as the date of a prior health screening or another protocol-defined baseline clinical date. Incident disease status for each target disease or condition will be ascertained by retrospective review of electronic medical records for up to 10 years after the index date. The study integrates retrospective clinical, health screening, laboratory, imaging, and electronic medical record data with prospectively collected biospecimen, proteomic, genomic, questionnaire, lifestyle, and digital health data. Prospective study procedures will be completed over approximately 1 week, with up to 2 additional weeks if needed. By combining multimodal data, this study seeks to improve disease risk prediction and to identify clinical and biological factors associated with disease onset, ultimately supporting personalized risk stratification and preventive healthcare strategies.