Clinical Research Directory

The Ability of Chronic Pain Patients to Self-diagnose Their Chief Source of Low Back Pain

The investigative team will provide 27 slides with bullet points and images of pain referral patterns for different causes (e.g., herniated disc, facet joint arthritis) for patients seen for a new visit with a chief complaint of chronic low back pain. This material is all publicly available but has been compiled in presentation form. This will have educational benefit for patients, discussing clinical signs and symptoms, risk factors and basic treatments. There will also be a smaller control group of that gets a condensed 4-slide presentation. After review of the slides, an independent observer will ask the patient what they think are the 2 most likely causes of their LBP (in order of likelihood) and match that with the attending physician and trainee, who will independently do the same. The investigative team will then determine how concordant the patient's answers are with the physicians and also record outcomes.

Intra-discal Injection of PRP for Low Back Pain

Low back pain (LBP) is the second cause of medical visits in France. Indeed, its incidence can vary between 60 and 90%. LBP is also the leading cause of disability in the adult population in France and in the rest of the world. Its evolution towards chronicity is observed in less than 8% of cases, but it is responsible for 85% of the medical costs. Degenerative disk disease (DDD) is a major cause of chronic LBP (\> 40%). DDD can be characterized by peculiar Magnetic Resonance Imaging (MRI) features with a strong correlation between pain and inflammatory aspect of the disk, which result in the so-called active discopathy (AD) (Brinjikji et al. 2015). Modic classification based on MRI of the lumbar spine is considered as a reference. Type 1 Modic signal changes are characterised by a low-intensity signal on T1-weighted sequences and hyperintense signal on T2-weighted sequences, with gadolinium injection enhancement, corresponding to bone marrow oedema. Type 1 Modic is very rare in an asymptomatic population but may be found in 5% to 40% of chronic LBP patients underscoring its symptomatic involvement. No currently reference treatment is available for AD. PRP technology has recently been widely developed in osteoarthritis and tendon injuries. Therapeutic benefit of PRP has being evaluated. For instance, no randomized controlled trials (RCTs) have specifically evaluated the effect of PRP in AD (Modic 1 signal). The availability of PRP for intra- discal injection could become an innovative therapeutic option in humans, especially for AD forms where inflammatory process is clearly predominant. The objective of the study is to evaluate the 3-month efficacy on pain and function (by achieving 30% improvement in Oswestry Disability Index) of one intra-discal PRP injection versus placebo (saline solution) in subjects with LBP associated with AD lasting more than 3 months.

Telerehabilitation for Patients With Chronic Low Back Pain (TeleBACK Clinical Trial)

The investigators will conduct a prospective, randomized, clinical trial addressing key questions to understanding the effectiveness of telerehabilitation (physical therapy delivered via video-visits) and in-clinic physical therapy for patients with chronic low back pain (LBP). The investigators also seek to understand how patients engage with both care options and how these treatment options influence other LBP-related healthcare utilization. The investigators will explore implementation outcomes using a mixed methods approach consisting of electronic surveys and semi-structured interviews with patients, physical therapists, practice managers, and outpatient services administration focusing on perceived quality and impact on barriers to care. The investigators will enroll 1000 patients with chronic LBP seeking outpatient care at the healthcare systems in Maryland (Johns Hopkins Medicine (JHM)) and Utah (University of Utah (UU) and Intermountain Healthcare (IHC)). Eligible patients will provide informed consent and be randomized to receive telerehabilitation or in-clinic physical therapy delivered by a trained physical therapist. Primary effectiveness outcome is the difference in change in LBP-related disability (Oswestry Disability Index) after 8 weeks of treatment.

Efficacy of Cognitive Functional Therapy in Individuals With Chronic Low Back Pain After Spinal Surgery

Chronic low back pain after spinal surgery is a complex and disabling condition influenced by biopsychosocial factors. Cognitive Functional Therapy (CFT) is a promising intervention targeting these multidimensional aspects. This randomized, sham-controlled trial aims to compare the efficacy of CFT versus a sham intervention (detuned photobiomodulation) in participants with chronic low back pain after spinal surgery.

Effectiveness of Thoracolumbar Fascia Mobilization and Ultrasound-Guided 5% Dextrose Injection in Chronic Low Back Pain

The aim of this study is to investigate the effects of thoracolumbar fascia mobilization and ultrasound-guided thoracolumbar interfascial 5% dextrose injection on pain, range of motion, disability, quality of life, proprioception, and fascial thickness and echogenicity in patients with nonspecific chronic low back pain. -Primary Objective: The primary objective is to evaluate the effects of these interventions on pain, functional status and range of motion. -Secondary Objective: The secondary objective is to assess the long-term effects on quality of life, proprioception, fascial thickness, and echogenicity.

Personalized and Automated Digital Coaching in People With Non-specific Chronic Low Back Pain

The investigators hypothesize that a personalized and automated digital coaching could reduce activity limitations in people with chronic low back pain as compared to usual care

Sequential and Comparative Evaluation of Pain Treatment Effectiveness Response

VETERANS ONLY. Chronic low back pain (cLBP) is common. Most Americans will have at least one episode of low back pain in their lifetimes. Approximately 50% of all US Veterans have chronic pain, and CLBP is the most common type of pain in this population. This study will use a sequential randomized, pragmatic, 2-step comparative effectiveness study design. The main goal is to identify the best approach for treating cLBP using commonly recommended non-surgical and non-pharmacological options. The first step compares continued care and active monitoring (CCAM) to internet-based pain self-management (Pain EASE) and an enhanced physical therapy intervention that combines Pain EASE with tailored exercise and physical activity. Patients who do not have a significant decrease in pain interference (a functional outcome) in Step 1 and those desiring additional treatment will be randomized in Step 2 to yoga, spinal manipulation therapy (SMT), or therapist-delivered cognitive behavioral therapy (CBT). Participants proceeding to randomization in Step 2 will be allowed to exclude up to one of the three Step 2 treatments based on their preferences. The investigators' primary hypothesis for the first treatment step is that an enhanced physical therapy intervention that combines pain self-management education with a tailored exercise program will reduce pain interference greater than internet-based pain self-management alone or CCAM in Veterans with cLBP. The primary outcome is change in pain interference at 3 months, measured using the Brief Pain Inventory (BPI) pain interference subscale. Study participants will be followed for one year after initiation of their final study treatments to assess the durability of treatment effects. The study plans to randomize 2529 patients across 20 centers.

Chronic Low Back Pain and Neck Pain Prospective Study

This prospective observation multifaceted study aims: 1. To perform a large prospective study and identify multiple "omics" biomarkers in chronic low back pain 2. To validate identified biomarkers for progression of acute to chronic low back pain 3. To validate identified biomarkers and test their heritability/validity in additional cohorts 4. To identify pathways and relevant individual variations for generation, propagation and subsidence of pain 5. To identify new imaging biomarkers related to chronic low back pain 6. To develop a registry of neck and low back pain subjects to help monitor the health-care management and utility to improve protocols and patient outcomes.

Virtual Reality-Based Rehabilitation Versus Conventional Therapy in Patients With Chronic Low Back Pain

This study aims to evaluate the effectiveness of rehabilitation using virtual reality compared with conventional physiotherapy in patients with chronic low back pain. The study will be conducted as a prospective, randomized controlled trial including 80 patients aged 40-65 years diagnosed with chronic low back pain lasting at least three months. Participants will be randomly assigned to two groups: an experimental group receiving conventional rehabilitation supplemented with non-immersive virtual reality training using the Tecnobody Homing Studio system, and a control group receiving conventional rehabilitation alone. Both groups will participate in a four-week rehabilitation program. The virtual reality training will replace a portion of conventional exercises and will focus on improving movement quality, postural control, coordination, and functional mobility through interactive tasks with visual and auditory biofeedback. The system utilizes a 3D camera enabling markerless motion analysis and real-time visual feedback to support movement correction and identification of functional deficits. Outcome measures will include assessments of balance, posture, joint mobility, lower limb strength and endurance, pain intensity, pressure pain threshold, kinesiophobia, perceived stress, anxiety and depression, functional disability, quality of life, and motivation for physical activity. Measurements will be conducted at baseline, immediately after completion of the four-week rehabilitation program, and at an eight-week follow-up. The results of this study are expected to provide clinical evidence regarding the effectiveness of virtual reality-assisted rehabilitation in patients with chronic low back pain and may contribute to the development of evidence-based rehabilitation strategies incorporating digital technologies.

Investigating Novel Interventions for Low Back Pain in US Military Veterans: A Randomized Controlled Adaptive Phase II Trial

Chronic pain symptoms are very common among U.S. Military Veterans and have a profound negative impact on mental health symptoms and quality of life, in addition to increasing risk for suicidal ideation and suicidal behaviors. There are currently extremely few safe and effective pharmacological treatments for chronic pain disorders, and the clinical need to develop new therapeutics for pain has never been more urgent. Fueled by the worsening opioid crisis and further exacerbated by the COVID-19 pandemic, opioid and other drug overdose deaths have climbed to staggeringly high levels. The rapid development of medications for the management of chronic pain conditions that are safe, well-tolerated, efficacious and non-addicting is thus of paramount importance. The two neurosteroid candidates to be investigated in this trial are naturally occurring molecules enriched in human brain and potentially ideal candidates for safe and effective chronic pain treatment.

Ultrasound-Guided Lumbar Facet Joint Injections for Facet-Related Pain: A Randomized Comparison of Saline, Steroid, and 5% Dextrose

This study aims to evaluate the effectiveness of prolotherapy using 5% dextrose compared to steroid and saline injections in patients with lumbar facet joint-related low back pain. The study is designed as a randomized, double-blind clinical trial conducted in a tertiary physical medicine and rehabilitation center. Participants will be randomly assigned to receive one of the three treatments. Clinical outcomes including pain intensity, functional status, and physical performance will be assessed at baseline, 1 month, and 3 months. The results of this study may help determine the short-term effectiveness of prolotherapy as a treatment option for chronic low back pain.

Assessing Central Aspects of Pain

BACKGROUND: Chronic pain continues for more than 12 weeks despite medication or treatment. Chronic pain is the main symptom of muscle and joint problems, rarely explained by damage to the muscle and joints alone. Activity in the central nervous system (CNS; nerves, spinal cord, and brain) pathways governs our ability to describe pain intensity and our emotional response to pain. Musculoskeletal conditions (e.g., inflammatory arthritis, osteoarthritis, low back pain, fibromyalgia) share altered CNS pathways, acknowledged by recent classifications of 'primary' and 'nociplastic' pain. Clinically useful tools to diagnose and measure activity and reveal abnormalities in these CNS pathways are needed to improve clinical decisions and accelerate new treatment development. Laboratory pain sensitivity testing and brain imaging confirm the CNS as a primary contributor to pain. These assessments are less acceptable or unfeasible for clinical practice. Simpler clinical pain sensitivity assessments are being developed. The investigators simple Central Aspects of Pain (CAP) questionnaire detects some people with pain sensitivity and knee, rheumatoid arthritis or low back pain. Combining the CAP questionnaire reflecting emotional processing and simpler pain sensitivity assessment, combining two different dimensions should be better than either approach alone. PURPOSE: To optimise diagnosis and measurement of CNS as the primary contribution to chronic musculoskeletal pain by using the CAP questionnaire and simpler pain sensitivity assessments to ensure timely, effective diagnosis and treatment. OBJECTIVES: 1. Assess the ease, ability and performance of the combined CAP questionnaire and simpler pain sensitivity assessments to identify CNS as the primary contributor to chronic pain across musculoskeletal conditions. 2\. Use the CAP questionnaire alone or with substitute measures of activity in CNS pathways, demographic, and clinical variables to indicate pain levels at six and twelve weeks. 3\. Understand the relationship between CAP and simpler pain sensitivity assessment with laboratory pain sensitivity assessments as a tool to inform the current CNS activity contributing to pain. 4\. Evaluate associations between the CAP questionnaire and simpler pain sensitivity assessments with patient outcomes.

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.

MBM and taVNS for Low Back Pain and Depressive Symptoms

This two-arm randomized controlled trial aims to test the preliminary effect of home-based mindfulness-based meditation and transcutaneous auricular vagus nerve stimulation on managing pain and depressive symptoms among community-dwelling older adults with chronic low back pain and depressive symptoms; and the effect of home-based mindfulness-based meditation and transcutaneous auricular vagus nerve stimulation on the host Brain-Gut Axis.

Impact of Leisure Activities on Quality of Life in Low Back Pain

Chronic low back negatively impacts upon physical and mental quality of life. The relationship between pain, physical function and physical activity levels has been largely studied in low back pain. However the impact of leisure activities on the quality of life of patients with low back pain is unknown. In other patient populations, a high engagement with leisure activities has been associated with better health-related quality of life.

Efficacy of Low-Dose Laser Acupuncture for Low Back Pain

This study will evaluate whether low-dose laser acupuncture can reduce pain and improve daily function in adults with chronic low back pain. The trial is a double-blinded, randomized, two-arm, parallel, multi-centred study.

Study of the Contribution of Osteopathic Treatment to Classic Medical Management in Patients With Chronic Low Back Pain

The management of chronic low back pain is now part of a multi-disciplinary set of proposals with the aim of adapting for each patient orientations of both medicated and non-medicated care. Very classically, analgesic treatment of stage I or II is of use, reinforced by the occasional use of NSAIDs in the absence of contraindication. In this medical attempt of the control of the pain associates a physical care (supervised exercises, physiotherapy care), cognitive and behavioral therapy, multidisciplinary care. Osteopathic treatment is a specific manual diagnostic and therapeutic procedure. This study aims to evaluate the relevance of providing osteopathic treatment in combination with classical medical treatment in the management of patients with chronic non-specific low back pain.

Treatment of Chronic Lower Back Pain With a Combination of Electrical Stimulation, LED, and Laser Therapy

This study will evaluate the impact of the Neurolumen medical device on chronic low back pain.

Phenotyping Response to Spinal Cord Stimulation in Chronic Low Back Pain

Chronic low back pain (CLBP) is a debilitating condition and costly to treat. Long-term drug treatment often fails due to habituation, breakthrough of pain, or adverse effects of drug treatment. Opioid use to manage this pain has contributed to the opioid epidemic. Spinal cord stimulators have emerged as a promising treatment and reduces reliance on drugs. However, response to spinal cord stimulation (SCS) is unpredictable. It is difficult to predict which patients will respond positively to SCS because the physiological mechanism for treatment responsiveness is unclear. Therefore, the aim of this study is to investigate how spinal cord stimulators affect functional measures in patients with CLBP, including functional MRI, neurophysiology, gait analysis, and questionnaires. The results of this study can lead to the widespread adoption of spinal cord stimulators as a safe and effective therapy for CLBP, reducing the reliance on opioids and mitigating the opioid epidemic's impact.

Validation of a Virtual Reality Timed Up and Go Test in Adults With Chronic Non-Specific Low Back Pain

This study evaluates whether an immersive virtual reality (VR) version of the Timed Up and Go (TUG) test can accurately measure functional mobility in adults with chronic non-specific low back pain. The standard TUG test measures the time needed to stand up from a chair, walk 3 meters, turn around, walk back, and sit down. In the VR version (VR-TUG), participants perform the same movements while wearing a VR headset that displays a virtual environment. We will examine: (1) whether VR-TUG results are similar to the standard TUG, (2) whether VR-TUG is reliable when repeated about one week later, and (3) whether VR-TUG performance is associated with pain, disability, and fear of movement. Participants will complete questionnaires (VAS, ODI, and TSK), perform standard TUG and VR-TUG at baseline, and repeat VR-TUG 7 ± 2 days later. Results will help determine whether VR-based functional mobility testing is a practical assessment tool for people with chronic low back pain.

The Effect of ESWT Added to Conservative Treatment on Pain, Disability, and Ultrasonographic Outcomes in Chronic Low Back Pain

Chronic low back pain (CLBP) is a major public health concern worldwide, leading to reduced quality of life and significant work loss. It is defined as pain lasting more than 12 weeks between the lumbar and sacral spinal segments. The global prevalence of CLBP ranges from 13.1% to 20.3%, and the number of affected individuals has increased from 370 million in 1990 to 570 million in 2017. Core muscles, including the multifidus, erector spinae, transversus abdominis, psoas major, and quadratus lumborum, play a key role in spinal stabilization. In patients with CLBP, dysfunction and loss of synergy among these muscles can compromise spinal balance. Prolonged poor posture can reduce the strength and endurance of the lumbar erector spinae, multifidus, and transversus abdominis, leading patients to compensate by overusing the erector spinae, rectus abdominis, and oblique abdominal muscles. This compensation is considered one of the primary contributors to chronic low back pain. These deep core muscles can be objectively evaluated using ultrasonography (USG), a non-invasive, inexpensive, and accessible imaging method. Strain elastography, a quantitative ultrasonographic technique, is increasingly used to assess tissue stiffness and monitor structural changes in muscle over time. Conventional treatments for CLBP include pharmacotherapy, exercise, and physical therapy. In recent years, extracorporeal shock wave therapy (ESWT) has emerged as a non-invasive, easily applicable, and low-risk treatment method. ESWT is widely used in various musculoskeletal conditions such as lateral epicondylitis, patellar tendinopathy, and calcific tendinitis of the shoulder. Studies have shown that ESWT provides pain relief and functional improvement in patients with CLBP through its angiogenic, anti-inflammatory, analgesic, and tissue-regenerative effects. Several studies have demonstrated the positive impact of ESWT on pain reduction and functional recovery in CLBP. A recent meta-analysis reported that ESWT significantly reduces pain in CLBP patients and may be superior to other conservative treatments. Yue et al. (2021) highlighted the short-term benefits of ESWT in reducing pain and disability, while also emphasizing the need for well-designed randomized controlled trials (RCTs) to establish high-quality evidence. Similarly, Wu et al. (2023) underscored the necessity of including objective outcomes in future RCTs to better evaluate the efficacy of ESWT. Although numerous studies have assessed the effects of ESWT on pain, disability, and functional outcomes in CLBP, to date, no study has objectively evaluated its effectiveness using ultrasonographic strain elastography focusing on the elasticity and stiffness of core muscles. This study aims to be one of the first to assess the long-term effects of ESWT using objective measures. Its contribution to the literature lies in evaluating the efficacy of ESWT, when added to conventional physical therapy, through long-term monitoring with ultrasonographic strain elastography in patients with CLBP.

RenewDisc Trial: Endoscopic Discectomy and Autologous Stem Cell Therapy for Discogenic Low Back Pain

he RenewDisc Trial is a prospective observational clinical study evaluating outcomes in patients with confirmed discogenic low back pain who undergo standard clinical care using endoscopic spine procedures. The study observes and compares clinical, functional, and imaging outcomes following endoscopic discectomy, endoscopic discectomy combined with autologous mesenchymal stem cell therapy, or standalone endoscopic application of autologous mesenchymal stem cells. Participants are treated according to routine clinical decision-making, and no interventions are assigned by the study protocol. Data are collected prospectively at predefined follow-up intervals to assess pain intensity, functional disability, quality of life, and structural changes on magnetic resonance imaging.

Active Music-Based Intervention in Patients With Chronic Low Back Pain

The goal of this clinical trial is to learn if active music-based intervention works to treat patients with chronic low back pain. The main questions it aims to answer are: 1. Does active music-based intervention improve cognitive function? 2. Does active music -based intervention improve sensitivity to stimuli? 3. Does active music-based intervention improve pain catastrophizing behavior? 4. Does active music-based intervention improve quality of life? Participant will visit the clinic for 5 sessions of assessments and active music-based intervention over 2 weeks. On the first visit, it will take each participant 45 minutes to complete the pre-intervention assessments followed by a 45-minute active music-based intervention. The active music-based intervention will last about an hour for the remaining 4 visits. On the 5th or last visit, after the one-hour intervention, it will take another 30 minutes for each participant to complete the post-intervention assessments.

Pain Neuroscience Education Combined With Lumbar Stabilization Exercises on Disability and Kinesiophobia Among Patients With Chronic Low Back Pain

This study will investigate the effect of adding Pain Neuroscience Education (PNE) to a standard lumbar stabilization exercise program on disability and kinesiophobia among patients with chronic low back pain in the Gaza Strip. Participants will be randomly assigned into two groups: Control group - will receive lumbar stabilization exercises only. Experimental group - will receive lumbar stabilization exercises in addition to PNE delivered once weekly for 8 sessions. Both groups will undergo an 8-week intervention, and outcome measures will be collected at baseline, post-intervention (8 weeks), and at a follow-up assessment (16 weeks) to evaluate the persistence of treatment effects. It is expected that the experimental group will show greater improvements in disability and kinesiophobia compared with the control group, indicating that integrating PNE with stabilization exercises may provide enhanced and sustained benefits for patients with chronic low back pain.