Clinical Research Directory

Fear-Avoidance Beliefs and Physical Function in Patients With Lumbar Disc Herniation

Lumbar disc herniation is one of the most common causes of low back pain and is associated with substantial functional limitations and reduced quality of life, particularly among working-age individuals. Displacement of disc material toward the spinal canal may result in mechanical compression and inflammation of the nerve roots, leading to pain, restricted movement, and reduced functional performance. The course of low back pain cannot be explained solely by biomechanical and anatomical factors. Psychosocial factors also play an important role in symptom persistence and functional outcomes. Within this context, the fear-avoidance model provides an important theoretical framework, suggesting that individuals may develop fear of movement and avoid physical activities because they believe these activities may increase pain or cause further injury. Over time, avoidance behaviors may contribute to physical deconditioning, reduced muscle function, and increased functional impairment. The Fear-Avoidance Beliefs Questionnaire is commonly used to assess individuals' beliefs regarding the relationship between pain, physical activity, and work-related activities. Higher levels of fear-avoidance beliefs have been associated with greater pain severity, increased disability, and poorer physical performance in individuals with low back pain. Trunk muscle endurance plays a key role in maintaining spinal stability. Adequate endurance of the paraspinal and abdominal muscles supports mechanical stability of the spine and contributes to the safe performance of functional movements. The Biering-Sørensen Test and plank test are commonly used to assess trunk muscle endurance in clinical and research settings. The Biering-Sørensen Test evaluates the endurance of the trunk extensor muscles, whereas plank-based tests assess the endurance of the anterior and lateral trunk musculature. Functional impairment in individuals with low back pain can be evaluated using the Oswestry Disability Index, a self-reported questionnaire that assesses limitations experienced during activities of daily living. Functional mobility and performance may also be evaluated using the Timed Up and Go test, which involves standing up from a chair, walking a short distance, turning, returning to the chair, and sitting down. This test reflects mobility, dynamic balance, and functional performance during daily activities. Postural control and balance may also be affected in individuals with low back pain. Reduced static balance performance can negatively influence functional activities and mobility. The Single-Leg Stance Test is a practical clinical measure used to assess postural stability and static balance. Although previous studies have examined associations between psychosocial factors and functional status in individuals with low back pain, studies evaluating the relationship between fear-avoidance beliefs, trunk muscle endurance, balance, and functional performance together remain limited. Identifying these relationships may contribute to the development of more comprehensive rehabilitation programs for individuals with lumbar disc herniation.

Comparison of Clinical Effectiveness of Full Endoscopic Lumbar Discectomy (FELD) and Microdiscectomy (MD) in Patients With Lumbar Disc Herniation

The goal of this clinical trial is to compare the clinical effectiveness of Full Endoscopic Lumbar Discectomy (FELD) and Microdiscectomy (MD) in patients aged 18-85 with single-level lumbar disc herniation who have not undergone prior lumbar surgery. This study also aims to perform a radiological analysis of MRI scans before and after treatment to optimize patient selection and surgical strategies. The main questions it aims to answer are: * Does FELD provide superior early postoperative pain relief (measured by VAS) compared to MD? * Does FELD offer better functional recovery (measured by COMI and ODI scores) postoperatively compared to MD? * Can radiological analysis of pre- and post-operative MRI images help optimize patient qualification and guide surgical strategies? Researchers will compare patients undergoing FELD to those undergoing MD to see if endoscopic techniques result in faster recovery and lower early postoperative pain while maintaining similar long-term outcomes. The study will also analyze how MRI findings correlate with clinical outcomes to refine operative decision-making. Participants will: * Undergo either FELD or MD surgery * Complete VAS, COMI, and ODI questionnaires at pre-specified follow-up intervals (1, 3, 6, and 12 months post-surgery) * Have MRI scans 24 hours before surgery, 24 hours after surgery, and at each follow-up to assess disc recurrence, residual pathology, and to optimize surgical strategies.

Neural Control and Mechanosensation in Spine Muscle

Low back pain (LBP) is a condition that affects a majority of the US population and is responsible for a significant proportion of health care costs and utilization. Lumbar spine muscle is compromised in LBP, and do, and do not, respond to exercise based physical therapy program depending on measurements representing activation capacity of lumbar muscle. Here, we will characterize the neurological and muscle specific features that may contribute to limited activation in an attempt to identify sources of resistance to recovery in patients with chronic disc injury and identify precision rehabilitation approaches for this complex population of individuals.

Discogen for Low Back Pain

This study will be a double-blinded, two-arm, prospective, randomized controlled pilot feasibility study in 40 evaluable subjects (20 in each arm) at one study site within the United States. Subjects in Arm 1 will receive unilateral Discogen treatment; subjects in Arm 2 will receive unilateral sham treatment (control). Treatment in both arms can include medications, e.g. NSAIDs or muscle relaxants for axial or radicular pain.

Safety And Performance Of Disc Care To Prevent Lumbar Disc Herniation Recurrence

The goal of this clinical investigation is to learn about DISC Care, an Hernia Blocking System, in patients who have undergone lumbar disc hernia surgery. The main questions it aims to answer are: * if the implant (DISC Care) prevents disc herniation recurrence * if DISC Care is a safe device Participants will be implanted with DISC Care and followed up for two years (7 visits).

Adjacent Level Anterior Cervical Fusion: SeaSpine Shoreline Versus Removal of Previously Implanted Plate and Replating

The purpose of this study is to evaluate the efficacy of SeaSpine Shoreline device in surgery of the cervical spine.

Caudal Neuroplasty Using Epidural Catheter Combined with Pulsed Radiofrequency (versus Pulsed Radiofrequency Alone

Evaluating the superiority of caudal neuroplasty using epidural catheter (Perifix® Complete Set 16 G) combined with Pulsed Radiofrequency (PRF) versus Pulsed Radiofrequency (PRF) alone targeting the dorsal root ganglion In patients with lumbar radicular pain on pain reduction and quality of life within six months follow up.

PREventing Pain After Surgery

The present study aims to adapt and modify a brief presurgical Acceptance and Commitment Therapy (ACT) intervention aimed at preventing the transition to Chronic Post-Surgical Pain (CPSP) and reducing long-term opioid use. Investigators will then assess the acceptability, feasibility, and preliminary efficacy of the finalized intervention to prevent the transition to CPSP and reduce post-surgical opioid use six months following lumbar spine surgery. Finally, investigators will identify psychosocial and psychophysical phenotypes associated with response to this intervention.

Silent Lumbar Disc Herniation Syndrome

LDH is a common phenomenon that is often described in association with various pathological processes affecting the neuromuscular and locomotor systems. It is not only associated with pathology but it can also be observed in healthy individuals with no evidence of any dysfunction. Since LDH is observed in such a large percentage of healthy subjects, it is probably more appropriate to perceive it as a physiological phenomenon with silent clinical biomechanical changes

Applying Artificial Intelligence in Developing Personalized and Sustainable Healthcare for Spinal Disorders

The primary objective is to use machine learning methods on large survey and health register data to identify participants with different treatment trajectories and health outcomes after surgical and/or conservative treatment for spinal disorders. Secondary objectives are to 1) conduct external validation of the prediction models, and 2) explore how the prediction models can be implemented into AI-based clinical co-decision tools and interventions.

Effects of Cognitive Intervention Therapy on Postoperative Delirium

This study is a prospective, single-center, randomized controlled trial to compare whether applying cognitive intervention therapy before and after surgery in elderly patients aged 65 years or older undergoing non-cardiac surgery can reduce the incidence of postoperative delirium compared to conservative treatment.