Clinical Research Directory

Clinical and MRI Findings in Lumbar Disc Disease

Low back pain related to lumbar disc disease is a very common condition. Doctors frequently use Magnetic Resonance Imaging (MRI) to look at the spine and diagnose these problems. However, it is not always clear how well the severity of the damage seen on an MRI matches the actual symptoms a patient is experiencing. Sometimes, patients with severe MRI findings have mild symptoms, and vice versa. The purpose of this observational study is to understand the relationship between a patient's clinical symptoms and their MRI results. Researchers want to see if the severity of the spinal damage shown on an MRI can accurately predict how much pain or disability a patient has. Participants in this study are adults (ages 18-70) who are already experiencing symptoms of lumbar disc disease and have recently had an MRI. During the study, participants will: * Complete a questionnaire about the intensity of their back and leg pain. * Fill out a survey about how their back pain affects their daily activities. * Undergo a standard physical and neurological examination by a doctor to check their reflexes, muscle strength, and sensation. Researchers will then compare these physical examination and questionnaire results with the detailed findings from the patient's MRI scans. The goal of this research is to improve diagnostic accuracy and help doctors make better, more personalized treatment decisions for future patients with lower back pain.

Nonpharmacologic Pain Management in FQHC Primary Care Clinics

The goal of this study is to improve pain management and reduce opioid reliance for patients with chronic back pain in Utah Federally-Qualified Health Centers (FQHCs). The study compares the effectiveness of nonpharmacologic pain treatments using telehealth to overcome access barriers. We will use automated EHR reminders for electronic referral to teleconsult services. Our project tests adaptive treatments and uses a hybrid type I design - focused on effectiveness outcomes while gathering implementation data to inform future efforts to scale effective strategies.

Evaluation of Stabilization Training With Biofeedback in Lumbosacral Spine Pain Syndrome

The aim of the study is to evaluate the effects of biofeedback-assisted stabilization training and conventional therapy on pain perception, balance, spinal mobility, functional performance, physical activity, stress level, and quality of life in patients with lumbosacral spine pain syndrome treated conservatively. The main research questions the study seeks to answer are as follows: Whether and to what extent the implemented therapeutic program improves balance, spinal mobility, functional performance, physical activity, quality of life, and reduces pain perception and stress levels in patients with lumbosacral spine pain syndrome? Are there differences in therapeutic outcomes depending on the treatment method applied? Are the therapeutic effects maintained three months after completion of the intervention? Researchers will compare two groups: a control group and an experimental group. In the control group, stabilization training will be performed without the use of biofeedback. Participants will undergo clinical and functional assessments (Visual Analogue Scale, Oswestry Disability Index, force platform measurements, etc.). Depending on the group to which participants are randomly assigned, participants will participate in manual therapy, stabilization training, and selected physical therapy modalities. Participants will be continuously supervised by a physician and physiotherapists throughout the 8-week intervention period. Three months after completion of the intervention, participants will undergo a follow-up assessment.

Impact of Low Back Pain Phenotypes on Function and Quality of Life in Ankylosing Spondylitis

This study aims to better understand different types of low back pain in patients with ankylosing spondylitis. Low back pain is a common problem in these patients and may affect daily activities and quality of life. A total of 200 patients with ankylosing spondylitis who have had low back pain for at least three months will be included in the study. Participants will be evaluated during a single visit. The study will assess pain severity, physical function, and quality of life using standard questionnaires. It will also examine how different pain types are related to these outcomes. The results of this study may help improve the understanding of pain in ankylosing spondylitis and support better patient management.

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 Kinesio Taping Versus Myofascial Release on Menstrual Low Back Pain

the aim of this study is to investigate the efficacy of kinesio taping versus myofascial release technique on menstrual low back pain in young females

Comparative Effects of Cognitive Functional Therapy With Kinetic Control Training on Non-specific Low Back Pain

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.

The Effect of Core Stabilization Exercises Applied With Virtual Reality-Based Telerehabilitation in the Treatment of Chronic Low Back Pain

A total of 80 patients, aged between 20 and 60 years, diagnosed with non-specific low back pain and not meeting the exclusion criteria, who registered at the outpatient clinics of the Department of Physical Medicine and Rehabilitation, Istanbul University, Istanbul Faculty of Medicine, between June 1, 2024 and June 1, 2025, were planned to be included in our thesis study, which was planned to be prospective, randomized and single-blind. After the patients are informed verbally and in writing about the purpose, duration and application method of the study and their consent is obtained, they will be asked to sign the "Informed Consent Form". Patient evaluation and follow-up forms will be filled out during pre-treatment and post-treatment follow-ups. After patients who meet the study inclusion criteria are included in the study, they will be numbered according to the order of application and then randomly assigned to the intervention group or control group by a computer program into 2 groups. In addition to a brochure containing patient education, showing the application method of core stabilization exercises, the number of sets and repetitions, the intervention group (G1) will receive a back school program in a total of 2 sessions of videoconference interviews, and the exercises will be explained to them, supported by visuals and videos. In addition, patients will be provided with the application that will be provided with your support, and will be provided with core stabilization exercises 3 times a week for 8 weeks. The control group (G2) will receive a brochure that includes patient education, showing the application method of core stabilization exercises, the number of sets and repetitions, as well as a face-to-face back school program in our hospital for a total of 2 sessions. The exercise program will be carried out face to face, 3 sessions per week for 8 weeks, at the Istanbul University, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation, under the supervision of a physician, with each exercise session being in groups of 8 people.

The Spine Phenome Project

The goal of this observational trial is to compare the health history and motion capabilities of participants with low back pain disorders to participants with healthy spines. The main question\[s\] it aims to answer are to: 1. Primary outcomes of this research effort include composite measures that differentiate between control and patient populations, predict injury or reinjury risk, identify low back and neck pain patient phenotypes, and evaluate treatment effectiveness. 2. Secondary outcomes of this research effort include an assessment of wearable motion sensor accuracy, characterization of motion assessment utility, biopsychosocial profiling of control and low back and neck pain patient populations, and differentiation of sincere and insincere motion assessment efforts. Participants will complete questionnaires and wear a motion monitor that will assess your back and/or neck. This session will be approximately 40-70 minutes. The research team will follow up with participants at 3 month, 6 months, 1 year, 2 years, 5 years to complete a short series of questionnaires and a motion assessment test.

Wearable Spine Health System for Military Readiness

The goal of this observational trial is to compare the health history and motion capabilities of participants with low back pain disorders to participants with healthy spines. The main question\[s\] it aims to answer are to: 1. Primary outcomes of this research effort include the development of composite measures or digital biomarkers to track functional recovery over time and predict duty or work status outcomes (return-to-full duty/work, limited duty/work restrictions or medical discharge/long-term disability). 2. Secondary outcomes of this research effort include characterization of motion assessment utility to predict reinjury risk and evaluate intervention effectiveness. In addition, exploratively, the investigators will determine biopsychosocial profiles of low back pain, and neck pain military populations to identify low back and neck pain phenotypes. Participants will complete questionnaires and wear a motion monitor that will assess the participant's back and/or neck. This session will be approximately 40-70 minutes. The research team will follow up with participants at 3 month, 6 months, and 1 year to complete a short series of questionnaires and a motion assessment test.

Trial-based Economic Evaluation of a Mobile Health Intervention for Individuals With Chronic Non-specific Low Back Pain

The aim of this trial is to assess the effectiveness and cost-effectiveness of a supervised and more personalised mhealth intervention compared with conventional exercise therapy in people with chronic non-specific low back pain.

Transcutaneous Electrical Nerve Stimulation (TENS) for the Treatment of Low Back Pain (LBP) in Adults

The goal of this clinical trial is to assess the effects and safety of transcutaneous electrical nerve stimulation (TENS) in adults with myofascial low back pain. Eligible participants will receive TENS treatment 5 times per week for 4 weeks. Pain intensity and functional outcomes will be assessed at baseline and weekly during the 4-week treatment period, and adverse events will be recorded.

Sodium Aescinate for the Treatment of Low Back Pain (LBP) in Adults

The goal of this clinical trial is to assess the clinical efficacy and safety of sodium aescinate in treating low back pain (LBP) in adult participants.

LLLT to Reduce Low Back Pain

The purpose of this research study is to gather information on the effectiveness of the Trident low-level laser therapy (LLLT) in combination with clinical patient education manuals to reduce lower back pain.

The Relationship Between Transversus Abdominis Muscle Architecture and Upper Extremity Function in Patients With Chronic Low Back Pain

Core stability is the ability to control the position and movement of the trunk for optimal production, transfer, and control of forces in the upper and lower extremities during functional activities. Studies have shown that TrA activation is delayed in individuals with low back pain. The relationship between core stability and the lower extremity has been frequently studied in the literature, and according to Kibler's 'Kinetic Chain' theory, loss of proximal stability is known to lead to dysfunction in distal segments; however, the relationship between the upper extremity and core stability is still unclear. The aim of our study is to investigate the upper extremity reach capacity and scapular stability of individuals with low back pain in relation to TrA involvement and to compare them with healthy individuals without low back pain.

Dronabinol as an Adjunct for Reducing Pain

This exploratory, proof-of-concept study is a double-blind (participants and investigators will be blinded), placebo-controlled, randomized, two-arm clinical trial of Marinol \[dronabinol, synthetic Δ9-tetrahydrocannabinol (THC)\] for chronic low back pain (cLBP) with a 2:1 allocation ratio. Up to 75 subjects will be enrolled in this pilot study and randomized to receive doses of THC (up to 30 mg/day), orally, over 8 weeks. This study will be conducted at a single site; it does not include any stratifications, and there is no interim analysis planned. Notably, the goal is to determine whether there is enough evidence of the safety of THC to support the development of later-phase clinical trials. Thus, detailed developmental plans are contingent on the outcomes of this study.

Physical Exam, Static & Dynamic Ultrasound Assessment, & Treatment of Thoracolumbar Fascia (TLF) Mediated Low Back Pain

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: Vincent 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. This 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. DoD: Machine Learning Analysis of Ultrasound Images for the Investigation of Thoracolumbar Myofascial Pain and Therapeutic Efficacy of Hydrodissection. The primary objectives of the proposed project are to: 1. develop reliable, quantitative image analysis approaches to objectively distinguish images from subjects with acute or chronic TLF pain from those without pain and 2. to assess the preliminary clinical efficacy of hydrodissection of the TLF as a novel therapeutic treatment for chronic LBP. AOA: Assessment of the Therapeutic Efficacy of OMT on Chronic Low Back Pain: An Integrated Sonographic and Machine Learning Analysis of Thoracolumbar Fascia Glide Impairment. The primary objectives of the proposed project are to: 1. assess the preliminary clinical efficacy of OMT as a therapeutic treatment for CLBP of TLF origin and 2. develop reliable, quantitative image analysis approaches to objectively distinguish images from subjects with TLF pain from those without pain. These 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. This 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. All 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. At 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. In 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. Specific Aim 1: Compare sonographic TLF imaging characteristics in individuals with acute versus chronic pain to those without low back pain. Specific Aim 2: Develop a machine learning (ML) classification algorithm to reliably distinguish abnormal myofascial tissue in acute versus chronic pain stages from healthy tissue. Specific Aim 3: DoD Study: Assess the preliminary therapeutic efficacy of hydrodissection as a novel treatment for TLF pain using quantitative US imaging and ML tools. AOA Study: Assess the preliminary therapeutic efficacy of OMT as a treatment for CLBP using quantitative US imaging and ML tools.

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.

Erector Spinae Plane Block for Acute Back Pain in the Emergency Department

The goal of this clinical trial is to learn if an erector spinae plane block (ESPB; a type of nerve block) works to reduce pain in adults presenting to the emergency department with low back pain. It will also learn if the ESPB reduces pain, disability, and return to work at 7 days. The main questions it aims to answer are: 1. Does the ESPB reduce short-term pain in participants with low back pain? 2. Does the ESPB reduce longer-term pain, reduce disability, and improve return to work and activities in participants with low back pain? Researchers will compare ESPB to a placebo (an injection that does not involve a nerve block) to see if ESPB works to treat low back pain. Participants will: Receive either the ESPB or a placebo injection in the emergency department Report their pain scores for up to 120 minutes Report their pain, disability, and return to work at 7 days

Effectiveness of Pilates on Postural Correction, Core Strength and Flexibility in Younger Individuals With Non-specific Low Backache

The aim of this clinical trial is to study the effects of Pilates intervention versus conventional therapy on postural correction, core strength and flexibility in young individuals with complaint of non-specific low backache. The main question is whether the Pilates has better improvement as compared to the conventional therapy on postural correction, core strength and flexibility moreover to compare the effectiveness of two intervention. Participants of age 18-25 years and with complaint of non-specific low backache will be recruited. 50 participants will be enrolled. Participants will perform Pilates and conventional therapy for 3 times per week for six weeks. Participants will be randomly allocated to two groups and assessor blinding will be done to take baseline assessment. Assessor blinding is done to minimize biasness. Pre and Post assessments will be taken by the assessor. SPSS will be used for the analysis of the data.

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.

Lumbar and Gluteal Motor Control in Chronic Low Back Pain

The present study aims to evaluate the effectiveness of an 8-week combined lumbar motor control and gluteal muscle strengthening program in individuals with chronic non-specific low back pain

Time to BBVNA Relief

Basivertebral nerve ablation (BVNA) is a minimally invasive procedure approved for vertebrogenic low back pain. While early studies support its efficacy, real-world evidence is still evolving, particularly regarding the trajectory of pain relief and functional improvement over time, and predictors of clinical response. This study aims to evaluate clinical outcomes longitudinally following BVNA and identify baseline predictors of response.

The Role of Proprioceptive Deficits, Psychosocial Factors and Inflammation in Pregnancy-related Pelvic Girdle Pain

A large proportion of pregnant women develop pregnancy-related low back and/or pelvic girdle pain (PPGP), which often does not recover spontaneously postpartum. As a result, 10% of women with PPGP are thus crucial. However, the underlying mechanisms of PPGP are still poorly understood. The main objective of this study is to investigate whether lumbar proprioceptive deficits, a disturbed body perception at the lumbar spine, psychosocial factors (incl. pain-related fear of movement, depression, anxiety and stress) and increased serum concentrations of specific inflammatory mediators are associated with (1) a reduced postural control and (2) the development and/or persistence of PPGP in multiparous women during the first and third trimester of pregnancy, and six weeks and six months postpartum.