Clinical Research Directory

Empowering Pain Psychology Access and Collaboration (EPPAC) to Improve Treatment Engagement Among Medicaid-insured Adults With Chronic Low Back Pain

Chronic low back pain (cLBP) is a leading cause of disability, with socioeconomically disadvantaged populations experiencing worse outcomes and lower rates of treatment initiation for evidence-based pain psychology services. Participant engagement strategies such as shared decision-making (SDM) and motivational interviewing (MI) have shown promise in improving treatment uptake, but no study has examined whether integrating these approaches into a pain psychology evaluation can improve engagement among socioeconomically disadvantaged participants or offered participants a structured choice between cognitive behavioral therapy (CBT) and emotional awareness and expression therapy (EAET), presented to participants as Pain and Emotion Reprocessing Therapy (PERT). The Empowering Pain Psychology Access and Collaboration (EPPAC) intervention, a brief, psychologist-led engagement strategy combining SDM and MI within a standard pain psychology evaluation, was developed to address this gap.

Exploring Multidimensional Trajectories in People With Low Back Pain

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. LBP 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. This 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. Established 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.

PRT for Chronic Low Back Pain

The goal of this clinical trial is to learn whether Pain Reprocessing Therapy (PRT) is a feasible and acceptable treatment to complete for working-age adults (ages 18-65) with chronic low back pain. The main questions it aims to answer are: Is PRT acceptable and feasible for people with chronic low back pain to complete? Does PRT help reduce pain intensity and interference, while improving functional outcomes in people with chronic low back pain? Researchers will compare PRT to a Monitoring and Education Program to see whether participants who receive PRT experience greater improvements in pain, daily functioning, and well-being. Participants will: * Be randomly assigned to the PRT group or the Monitoring and Education group * Participate in 8 intervention sessions over an 8-week period * Wear an activity monitor for 8 weeks * Attend a follow-up assessment after completing the intervention and another assessment 3 months later Please note that ClinicalTrials.gov will be used solely as a public study registry and not as a participant recruitment tool. The study team will not recruit participants or accept self-referrals through ClinicalTrials.gov. All participant recruitment will occur only through the Research Ethics Board (REB) approved recruitment methods.

A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight and Chronic Low Back Pain

The main purpose of this study is to evaluate the efficacy and safety of retatrutide in relieving chronic low back pain in participants who have obesity or overweight. Participation in the study will last about 80 weeks.

Bowen Therapy and McGill Stabilization Exercises in Chronic Low Back Pain

This randomized controlled trial aims to compare the effectiveness of Bowen Therapy combined with McGill stabilization exercises versus Bowen Therapy alone in individuals with chronic nonspecific low back pain. The study will evaluate changes in pain intensity, lumbar range of motion, and functional disability over a four-week intervention period. It is hypothesized that the combined intervention will produce greater improvements in clinical outcomes than Bowen Therapy alone.

Magnetic Resonance Elastography Of Chronic Low Back Pain Before And After Therapy

The purpose of this study is to quantify Magnetic Resonance Elastography (MRE)-derived mechanical property biomarkers of the lumbar paraspinal musculature and associated myofascial tissue regions before and after the intervention.

Efficacy of Antibiotic Treatment for Patients With Chronic Low Back Pain and Modic Type I Changes - Randomized Placebo-controlled Trial

The goal of this clinical trial is to learn if antibiotics (amoxicillin) work to treat chronic low back pain in adults. In some patients, this type of back pain may be caused by bacteria in the vertebrae, resulting in a condition known as "Modic type I change." The main questions the trial aims to answer are: * What is the efficacy (primary objective) of antibiotic treatment for patients with chronic low back pain and Modic type I changes? * What is the cost-effectiveness (secondary objective) of antibiotic treatment for patients with chronic low back pain and Modic type I changes? Researchers will compare amoxicillin to a placebo (a look-alike substance that contains no active drug) to see if amoxicillin works to treat chronic low back pain. Participants in the trial will: * Be invited for an MRI scan to determine if they have a Modic type I change; those who do will be included in the study. * Take either amoxicillin or a placebo daily for 100 days. * Take probiotics daily for 100 days to reduce the occurrence and impact of any side effects from the antibiotics. * Attend clinic visits at baseline (the start), 4 weeks, 3 months, and 12 months for checkups and tests. * Complete questionnaires at baseline, 3 months, 6 months, and 12 months.

Comparative Study on SNAG From Different Positions Low Back Pain Treatment

Objectives: To compare the effects of lumbar sustained natural apophyseal glides (SNAGs) applied in loaded versus unloaded positions on pain, disability, and function in individuals with chronic nonspecific LBP. Methods: A sample of 59 participants was assigned to receive six sessions of standard intervention, with lumbar SNAGs applied in either a loaded (sitting) or an unloaded (quadruped) position. This study was conducted between November 2025 and May 2026. Outcomes measured pre- and post-intervention included pain intensity (VAS), lumbar flexion range of motion (BROM device), and functional disability (Oswestry Disability Index).

Study of Correlation Between Serum BDNF Levels and Pfirmann Grading and IL- 1β

Brain-derived neurotrophic factor (BDNF) is a protein belonging to the neurotrophin family, known to be involved in neuronal survival, growth, and synaptic plasticity. Recent studies suggest that the role of BDNF may extend beyond the central nervous system to include inflammatory responses and degenerative changes in peripheral tissues. In particular, BDNF expression has been confirmed within intervertebral disc tissue, with degenerated discs showing increased BDNF expression compared to normal discs, and this expression has been reported to increase further with the severity of degeneration Intervertebral disc degeneration is closely associated with intradiscal nerve ingrowth (neoinnervation) and the resulting generation of pain, and BDNF has been reported as a factor mediating this nerve ingrowth and pain sensitization (central/peripheral sensitization) within the disc. Interleukin-1 beta (IL-1β), a representative inflammatory cytokine of disc degeneration, is known as a key mediator that promotes extracellular matrix degradation within disc tissue and induces neoinnervation and sensitization. Because BDNF secretion from neurons and immune cells has also been reported to increase in inflammatory environments, a potential interaction between IL-1β and BDNF has been proposed Accordingly, this study aims to measure serum BDNF concentrations in patients presenting with low back and leg pain due to disc degeneration or spinal stenosis, and to analyze whether these levels show a consistent correlation with Pfirrmann grading on MRI and serum IL-1β concentration.

SENECA - Smart Therapies for Chronic Pain

This will be a randomized controlled prospective pilot study: The feasibility and usability of VIVO 2nd GEN therapy + Standard-of-Care (SoC) vs. Standard-of-Care alone will be evaluated. At baseline, after informed consent and evaluation of inclusion and exclusion criteria, evaluation of pain on Numerical and qualitative pain rating scales, quality of life (EQ-5D-5L questionnaire), mental health (HADS questionnaire), and the effect of back pain on function and daily activities (ODI questionnaire) will be performed. After that, all patients will start their multimodal treatment plan. The control group will only receive SoC multimodal therapy training (this includes specifically: physio group therapy, water therapy, strength training, Nordic walking, massages, thermos therapy, lectures and trainings, psychotherapy, local electrotherapy). The treatment group will additionally receive pVNS as add-on therapy. Within this study the next generation device VIVO 2nd GEN will be used within a pVNS proofed indication. The study documentation in both groups will be supported by a digital diary App (VIVO® Pal) and an online dashboard for physicians/therapists (Therapy Management System - TMS), allowing for pseudonymized data entries and management. Patients will remain on treatment for 4 weeks. All patients will be evaluated using questionnaires (Numerical and qualitative pain rating scales, EQ-5D-5L, HADS, ODI) at baseline, weekly during treatment for 4 weeks, by end of treatment and at 4 weeks (optional 3 months and 6 months) follow-up (e.g., via telephone or the App, see below).

Neuroimmune Responses to Exercise in Chronic Back Pain

The goal of this mechanistic clinical trial is to learn how physical exercise affects the body and brain in people with chronic low back pain. The study will examine whether a 12-week online exercise program changes these measures compared with a waitlist group. Researchers will also study immune activity and brain function in people with chronic low back pain and compare them with healthy participants. Participants will complete questionnaires, provide blood samples, and undergo brain imaging scans.

Psilocybin-Assisted Physical Therapy in Chronic Low Back Pain

The purpose of this research study is to investigate whether a single administration of psilocybin can improve interoceptive awareness (awareness of bodily sensations) in individuals with chronic low back pain undergoing physical therapy, and whether these improvements are linked to pain relief and better physical therapy outcomes.

Efficacy of Electroacupuncture Combined With Auricular Acupressure for Chronic Low Back Pain.

Chronic low back pain (CLBP) due to lumbar spondylosis is a leading cause of disability, significantly impacting the quality of life in middle-aged and elderly populations. While electroacupuncture (EA) and auricular acupressure (AA) are recognized as safe, non-pharmacological therapies, high-quality clinical evidence specifically evaluating their combined effects on CLBP patients with TCM "Kidney Yin deficiency" syndrome remains limited.This randomized controlled trial aims to evaluate the efficacy and safety of combining EA with AA (utilizing Vaccaria segetalis seeds) compared to EA combined with sham AA. The study will focus on 76 eligible patients at Le Van Thinh Hospital. Primary objectives are to measure changes in pain intensity (VAS) and functional improvement (ODI) at three intervals: baseline (T0), after 7 days (T1), and upon completion of the 14-day intervention (T2). The findings are expected to provide an evidence-based foundation for an integrated treatment approach to manage chronic lumbar pain effectively.

Biologic Injection For Adults With Lumbar Disc Herniation

The goal of this clinical trial is to find out whether adding a bone-marrow aspirate concentrate (BMAC) injection during surgery can improve recovery in adults undergoing lumbar microdiscectomy for a lumbar disc herniation. The main questions it aims to answer are: * Does the BMAC injection lead to better disc tissue health after surgery (as seen on MRI scans)? * Does the BMAC injection lead to greater improvement in pain and disability compared to surgery alone? Participants will be adults aged 18 and older who are scheduled for lumbar microdiscectomy surgery. Researchers will compare one group of participants receiving the standard-of-care surgery plus the BMAC injection with another group receiving the same surgery without the injection to see if the injection offers added benefit. Participants will: * Have surgery (microdiscectomy) with or without the injection. * Complete pain and disability questionnaires at several times over 2 years. * Undergo MRI scans at baseline and follow-up to assess disc structure and tissue health. * Provide samples of leftover disc or bone-marrow tissue (as applicable) from surgery for analysis.

Chronic Low Back Pain Comorbidities: Unravelling Impaired Glucose Metabolism

Chronic low back pain (CLBP) is a global health problem. The first step for developing effective treatments is a better understanding of underlying mechanisms, including its comorbidities. Cumulative findings, including breakthrough findings from our own group, point to impaired glucose metabolism as an important CLBP comorbidity. In addition to its metabolic role, the insulin-like growth factor 1 (IGF1)/ growth hormone (GH) axis plays a key role in pain modulation. Therefore, the project aims to examine whether DNA methylation and functional protein levels predicts postprandial glycemic responses to standardized drinks, standardized meals, and real-life meals in patients with CLBP. This will be examined using two (i.e., 1 in CLBP and 1 in healthy controls) double-blind, randomized cross-over experiments (high versus low glycaemic index beverages). After the 14-day experimental phase, all participants will be studied for an additional week to examine whether the experimental findings have ecological validity, i.e., whether they can be confirmed in response to real-life meals in their home environment. Genome-wide changes in DNA methylation will be studied using whole genome bisulfite sequencing and targeted next-generation sequencing. The project allows identification of a biomarker for a potentially very significant CLBP comorbidity, including identifying targetable mechanisms to develop innovative, personalized treatments.

Effectiveness of ELDOA Stretching Combined With Standard Physiotherapy in Adults With Chronic Low Back Pain and Dural Hypomobility; A Randomized Controlled Trial.

Adults with chronic low back pain (CLBP) frequently experience persistent pain, functional disability, and reduced quality of life despite receiving conventional physiotherapy. Dural hypomobility has been proposed as a contributing factor in some individuals with CLBP by limiting normal neural tissue mobility and increasing mechanosensitivity. ELDOA (Étirements Longitudinaux avec Décoaptation Ostéo-Articulaire) is a targeted stretching technique designed to improve spinal decompression, fascial mobility, and neural tissue mobility. However, evidence regarding its effectiveness in patients with CLBP and dural hypomobility remains limited. This randomized controlled trial aims to evaluate the effectiveness of ELDOA stretching combined with standard physiotherapy compared with standard physiotherapy alone in adults with chronic low back pain and dural hypomobility. Participants will receive treatment three times per week for six weeks. Pain intensity, disability, and dural mobility will be assessed using the Numeric Pain Rating Scale (NPRS), Oswestry Disability Index (ODI), and Slump Test before and after the intervention. The findings may provide evidence regarding the additional benefit of ELDOA as an adjunct to conventional physiotherapy in the management of chronic low back pain associated with dural hypomobility.

Lumbar Extension Strengthening in Addition to Manual Therapy and Exercise for Chronic Low Back Pain

The goal of this clinical trial is to determine the effect of adding lumbar strengthening exercises to a program of manual therapy and motor control exercises (standard therapy) in adults with chronic low back pain (cLBP). Researchers will compare individuals with cLBP that receive lumbar extensor strengthening in addition to standard therapy compared to standard therapy alone to determine if there are differences in patient reported outcomes, lumbar multifidus thickness, low back endurance, and healthcare utilization between the groups. All participants will engage in 8-weeks of physical therapy, receiving manual therapy and motor control exercises. Those in the intervention group will have additional low back strengthening exercises.

Egoscue and Core Stabilization for Chronic Low Back Pain

Chronic low back pain is a widespread musculoskeletal condition that limits mobility and affects quality of life. It is often caused due to the poor posture, hyperlordosis and weak core muscles. This randomized clinical trial aims to evaluate the effectiveness of egoscue based postural correction combined with core stabilization exercises compared to core stabilization exercises alone in managing chronic low back pain. The primary outcomes measures includes numeric pain rating scale (NPRS), disability (Oswestry Disability Index), while secondary outcomes includes range of motion (Inclinometer), and posture (flexicurve Ruler).

Impairment Based Treatment Versus Modified Functional Restoration Program in Chronic Low Back Pain Patients

The aim of this feasibility study is to evaluate the practicality of conducting a future randomized controlled trial comparing two rehabilitation approaches for older adults with degenerative chronic low back pain: impairment-based treatment (IBT) and a modified short Functional Restoration Program (FRP). Impairment-based treatment is an individualized approach in which interventions are tailored to the patient's specific physical deficits, such as limitations in mobility, strength, and motor control. In contrast, the Functional Restoration Program is a structured, standardized approach focusing on improving overall functional capacity through progressive exercise, movement retraining, and activity-based rehabilitation. Participants will be randomly allocated to one of the two groups. Both interventions will be delivered by trained physiotherapists following standardized protocols over a 6-week period, with supervised sessions conducted according to a predefined rehabilitation schedule.

Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain

The goal of this clinical trial is to learn whether the Spinery® RF Generator and its sterile single-use accessories can safely lower disability and pain in adults with long-term low back pain that is thought to come from changes inside the vertebral bones of the lower spine. This type of pain is called vertebrogenic chronic low back pain. The study will include adults whose low back pain has lasted for at least 6 months and has not improved enough with non-surgical care. Participants must also have specific changes on spine magnetic resonance imaging (MRI), called Modic type 1 changes or selected Modic type 2 changes, at one or more levels between L3 and S1. The main questions this study aims to answer are: * Does the treatment improve daily function 3 months after the procedure? * Does the treatment lower low back pain? * Does the treatment improve quality of life? * What medical problems happen during or after the procedure? * Does the 6-week MRI show that the treatment reached the intended area inside the vertebra? All participants will receive treatment with the Spinery® RF Generator and accessories. There is no untreated comparison group. Participants will be assigned by chance to one of three ways of performing the radiofrequency ablation procedure. Radiofrequency ablation uses controlled heat to treat a small target area. In this study, the target is the basivertebral nerve, a nerve inside the vertebral body that may contribute to low back pain in some people. Participants will: * have screening tests, including spine MRI; * complete questionnaires about pain, daily function, and quality of life; * undergo the radiofrequency ablation procedure with the Spinery® RF Generator and accessories; * have an MRI about 6 weeks after treatment; * attend follow-up visits at 3 months and 6 months; * report any medical problems or changes in pain treatment during the study.

Pain Neuroscience Education for Chronic Pain

Chronic pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage, with a high prevalence in Spain (25.9%) and an average duration of 6.83 years, highlighting its significant health and social impact. Among its manifestations, chronic low back pain (CLBP) is the most common, affecting 58.1% of individuals with chronic pain, while fibromyalgia (FM) accounts for 10.4%. In both cases, a relevant proportion of patients do not present a clear organic cause, which complicates diagnosis and treatment and reflects the complexity of nonspecific chronic pain. CLBP is associated with a high functional and occupational impact, being one of the main causes of temporary disability. FM, on the other hand, is characterized by widespread musculoskeletal pain accompanied by fatigue, sleep disturbances, and emotional symptoms, constituting a condition with systemic involvement. Both conditions can occur throughout the lifespan, with variations in prevalence depending on age, sex, social class, and the presence of comorbidities. Aging introduces relevant differences in pain experience and treatment response. At the physiological level, changes occur in the musculoskeletal system, such as the progressive loss of muscle mass (especially type II fibers) and decreased bone mineral density, which increases the risk of sarcopenia and frailty. In contrast, young adults show greater anabolic capacity, better hypertrophic response, and higher neuromuscular efficiency, favoring faster adaptations to exercise. These differences justify the need to consider age as a key factor in the therapeutic approach. In addition to structural changes, central sensitization plays a fundamental role in the chronification of pain. This process involves sustained hyperexcitability of the central nervous system, with a reduced pain threshold and altered inhibitory mechanisms, contributing to the persistence of pain even in the absence of significant tissue damage. Therapeutic exercise (TE) is one of the main non-pharmacological interventions for chronic pain and has demonstrated effectiveness in reducing pain and improving functionality. However, its long-term effects are limited, largely due to adherence issues related to pain, as well as psychological, social, and educational factors. Educational level influences both the understanding of the intervention and adherence, generally being higher in young adults, which may affect treatment outcomes. In this context, Pain Neuroscience Education (PNE) has emerged as a complementary strategy aimed at improving understanding of pain mechanisms and promoting adaptive behavioral changes. The combination of PNE and TE has shown positive effects in patients with CLBP and FM, especially in variables related to pain and psychosocial factors. However, there is a lack of evidence regarding the impact of this combination on objective functional parameters, such as spinal movement during functional activities. Therefore, it is necessary to investigate the effectiveness of the combined intervention of PNE and TE not only on pain but also on biomechanical variables such as range, velocity, and quality of movement, using precise measurement instruments.

Focal Extracorporeal Shock Wave Therapy With Two Different Dosing Regimens for Chronic Low Back Pain

The purpose of this clinical trial is to evaluate and compare the efficacy of two different dosing regimens of focal extracorporeal shock wave therapy (F-ESWT) in patients diagnosed with chronic mechanical low back pain. Participants will be randomly assigned to one of two experimental groups to receive different parameters of shock wave intervention. The main objective is to determine which dosing scheme provides a more significant reduction in pain intensity and a better recovery of lumbar function.

A Mediation Analysis Investigating Dry Needling Treatment Mechanisms in a Chronic Low Back Pain Population

Low back pain is a common problem that many adults experience at some point in their lives. One treatment being studied is dry needling, a technique where a small needle is inserted into a specific area of muscle to help relieve pain. So far, the research on dry needling for low back pain hasn't been clear, and it's hard to know when and for whom it will work best. This study aims to figure out how dry needling works to help people with chronic low back pain by looking at the underlying factors. By understanding how dry needling helps people, we can develop a more targeted approach to treatment, which could lead to better outcomes for people with chronic low back pain. The goal of this study is to identify the factors that make dry needling effective for people with chronic low back pain, so that this this information can be used to provide more personalized and effective care. Eligible participants will attend 5 research sessions lasting approximately 1 hour and complete 2 online surveys. At 3 of those sessions, participants will receive dry needling to their low back. As part of the research, participants will complete questionnaires related to how pain effects their life. Participants will also undergo testing for muscle stiffness, low back mobility and strength, and pain sensitivity. To be included in this study participants must: * Be 18-65 years of age * Have low back pain for at least 3 months

Pain Resilience Therapy for Low Back Pain.

Chronic pain affects about 20% of adults in the U.S. and can lead to serious personal, social, and economic challenges. It is often treated with medications, including opioids, which carry risks of dependence. While pain education (PE) helps people better understand their pain and may reduce symptoms, it generally has only modest effects when used alone. The purpose of this study is to explore whether combining pain education with other treatments-such as physical therapy, cognitive behavioral techniques, and healthy lifestyle strategies-in a multi-modal resilience approach can offer greater benefits. The study aims to answer the following question: Can a combined, whole-person approach improve outcomes in people with chronic pain more effectively than pain education alone?