Clinical Research Directory

SERENITY Study of Chronic Pain Interference in Adults

SERENITY is a remote observational study designed to characterize inter-individual differences in chronic pain among adults with chronic low back pain and adults with spinal cord injury-related neuropathic pain. Participants will complete baseline assessments and intensive longitudinal data collection using ecological momentary assessment surveys, brief cognitive tests, and passive Fitbit data collection. Ecological momentary assessment surveys will be completed 4 times per day for at least 3 weeks and will assess pain interference, pain intensity, stress, affect, sleep, body and mind awareness, agency, medication use, manual therapy frequency, and related factors. The study will use Bayesian hierarchical modeling, clustering analyses, and causal discovery approaches to identify person-specific and group-level factors associated with pain interference.

Meditation for Older Adults With Chronic Low Back Pain

This pilot randomized controlled trial aims to recruit 66 community-dwelling older adults with chronic low back pain and follow up them for 8 weeks. This study aims to test the preliminary effect of a mindfulness-based meditation (MBM) intervention on pain and symptoms among community-dwelling older adults with chronic low back pain, and also to test the effect of the MBM intervention on the host Gut-Brain Axis (GBA).

Radiofrequency and Pelvic Floor-Core Exercise for Chronic Low Back Pain in Women With Pelvic Floor Dysfunction

The goal of this clinical trial is to learn whether capacitive-resistive radiofrequency, a supervised core and pelvic floor exercise programme, or both together reduce low back pain in premenopausal women with chronic non-specific low back pain and pelvic floor dysfunction. The main question it aims to answer is: do the three treatments differ in lumbar pain intensity (0-10 visual analogue scale) 1 week after the treatment ends? Researchers will also compare pain quality, low back disability, pelvic floor symptoms, urinary incontinence, pelvic floor muscle function and lumbar mobility up to 3 months after treatment. Sixty women will be randomly assigned to one of three groups: * Radiofrequency: nine weekly 20-minute sessions applied to the lower back and, through a vaginal electrode, to the pelvic floor. * Exercise: a 12-week programme of supervised group sessions (three 30-minute sessions per week) for the core and pelvic floor muscles. * Combined: both treatments at the same time. Participants will complete questionnaires and a physical examination before treatment and 1 week, 1 month and 3 months after treatment ends.

Erector Spinae Plane Block With or Without Thoracolumbar Fascia Injection for Chronic Low Back Pain

This study aims to investigate whether adding a thoracolumbar fascia (TLF) interfascial injection to an erector spinae plane (ESP) block improves pain relief and functional outcomes in patients with chronic axial low back pain. A total of 72 patients will be randomly assigned to one of two groups. The first group will receive ultrasound-guided ESP blocks alone, while the second group will receive ultrasound-guided ESP blocks combined with TLF interfascial injections. Both groups will undergo two treatment sessions one week apart. Pain intensity, functional disability, analgesic consumption, treatment success, and adverse events will be evaluated during a three-month follow-up period.

Veterans' Intervention Blending NeuRomodulation and YogA for Chronic Low BackPaiN Treatment: VIBRANT

The objectives of this VA Merit application are to demonstrate efficacy of combined intermittent theta burst (iTBS) and yoga (iTBS+yoga) intervention on improving pain, function, analgesic use, self-efficacy, quality of life and well-being among Veterans with chronic low back pain (CLBP). This Merit project will directly benefit Veterans and VA Services by demonstrating efficacy of a new, non-medication treatment for Veterans with CLBP in need of non-opioid treatment options. Neuromodulation including iTBS is now offered at over 50 VA hospitals and yoga is among the complementary and integrative health programs being rolled out as a part of VAs Whole Health implementation efforts. Thus, should iTBS+yoga ultimately prove to be efficacious, VA facilities will be well-poised to offer this treatment. A novel, activity-based, non-medication treatment for Veterans with CLBP is of great need given the high prevalence of CLBP.

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

The investigative team will provide 27 (28 with title) 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.

Visual Feedback-Assisted Sensorimotor Training in Chronic Nonspecific Low Back Pain

Chronic nonspecific low back pain is a common musculoskeletal condition that can negatively affect physical function and quality of life. This randomized controlled trial aims to investigate the effectiveness of visual feedback-assisted sensorimotor training on pain, functional disability, sensory discrimination, and lumbopelvic motor control in patients with chronic nonspecific low back pain. A total of 70 participants aged 18-65 years will be randomly assigned to two groups: visual feedback-assisted sensorimotor training or conventional exercise therapy. Both groups will receive 12 treatment sessions over four weeks, with three sessions per week. Participants will be evaluated at baseline, immediately after the four-week intervention, and one month after treatment completion. The primary outcomes will be pain intensity and functional disability. Secondary outcomes will include two-point discrimination, lumbopelvic motor control, fear of movement, pain catastrophizing, quality of life, and disability. The study aims to determine whether visual feedback-assisted sensorimotor training provides greater improvements than conventional exercise therapy.

Pain Neuroscience Education and Neuromuscular Exercise in Individuals With Chronic Low Back Pain and Central Sensitization

The goal of this randomized controlled study is to evaluate the effectiveness of pain neuroscience education (PNE) combined with neuromuscular exercises (NME) in individuals with chronic low back pain and central sensitization, and to compare the effects of this combined intervention with NME alone. The main questions it aims to answer are: * Does PNE combined with NME (PNE+NME) affect pain and functional outcomes in individuals with chronic low back pain and central sensitization? * Does NME alone affect pain and functional outcomes in individuals with chronic low back pain and central sensitization? * Does adding PNE to NME affect pain and functional outcomes compared with NME alone? Researchers will evaluate changes in pain and functional outcomes from baseline to post-intervention in both the PNE+NME and NME groups. Changes in outcomes will then be compared between the two groups to determine whether adding PNE to NME affects pain and functional outcomes compared with NME alone. Participants will: * Be randomly assigned to either the PNE+NME group or the NME group. * Participate in the assigned intervention for 8 weeks, with 2 sessions per week. * Complete outcome assessments at baseline and after the 8-week intervention.

Association of Subcutaneous Fat Index, Paraspinal Muscle Characteristics, and Facet Morphology With Lumbar Facet Joint Degeneration

This prospective observational study aims to investigate the association between subcutaneous fat index, paraspinal muscle characteristics, facet morphology, and lumbar facet joint degeneration in adults with chronic low back pain. The study will use lumbar magnetic resonance imaging (MRI) obtained as part of routine clinical care. The study will evaluate whether subcutaneous fat index is associated with moderate-to-severe lumbar facet joint degeneration and will also examine the relationships of disc degeneration, facet morphology, paraspinal muscle characteristics, and pain severity with facet joint degeneration.

Chronic Pain Treatment Whith Auricular Laserpuncture

The objective of the study is to evaluate the effectiveness of a treatment protocol using auricular acupuncture point stimulation with laser, compared with the use of mustard seeds, for reducing chronic pain in older adults. With this research, the researchers hope to obtain results that will allow the establishment of a non-invasive, easy-to-apply, and painless treatment protocol to minimize chronic pain in the lumbar spine, shoulders, and knees, thereby improving the quality of life of the target population. At the first session, before the start of the treatment protocol, three questionnaires will be administered: the SF-36 to assess quality of life, the Visual Analog Scale for pain intensity, and the McGill Pain Questionnaire. The pain region will also be assessed using a thermographic camera to evaluate skin temperature and the Ryodoraku System. The same evaluation protocol will be repeated before the fifth session and after the tenth session.

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.

Physical Activity and Exercise for Disability and Improving Mental Health in Elderly With Chronic Low Back Pain

This study evaluated the effects of a combined physical activity and structured exercise program on disability and mental health in elderly individuals suffering from chronic low back pain. Chronic low back pain is highly prevalent among older adults and is often associated not only with functional limitations and disability but also with psychological issues such as anxiety, depression, and poor sleep quality. Addressing both physical and mental health aspects is essential to improve overall well-being and quality of life in this population. Participants in the study will be randomly assigned to one of three groups. The Exercise + Physical Activity Program Group received a structured exercise regimen specifically designed to improve core strength, flexibility, balance, and overall mobility. In addition to the exercise sessions, participants were provided with a tailored physical activity program aimed at promoting daily movement, reducing sedentary behavior, and enhancing functional capacity in their everyday life. The Exercise-Only Group followed the same structured exercise regimen but did not receive the additional physical activity component, allowing for comparison of the effects of exercise alone versus combined interventions. The Control Group continued with usual care, which included standard advice for managing low back pain but no structured exercise or physical activity intervention, serving as a baseline to evaluate the effectiveness of the other interventions. Outcomes were assessed in terms of disability levels, measured using validated scales, as well as mental health parameters, including symptoms of depression, anxiety, and sleep quality. Post-intervention results indicated that participants in the combined exercise and physical activity group experienced the most significant improvements in functional ability, as reflected by reduced disability scores. This group also showed the largest reductions in symptoms of anxiety and depression and improvements in sleep quality. The exercise-only group demonstrated moderate improvements, highlighting the benefits of structured exercise alone, while the control group showed minimal changes in either physical function or mental health outcomes. Measurements will be taken pre , post (8 weeks of PT interventions) and 8 weeks follow up These findings emphasize the added value of integrating general physical activity into structured exercise programs. Incorporating daily movement and functional activity beyond formal exercise sessions appears to enhance both physical and psychological outcomes in elderly individuals with chronic low back pain. The study underscores the importance of a comprehensive approach in the management of chronic musculoskeletal pain in older adults, combining targeted exercise with strategies to increase overall daily activity levels.

Mapping Stress and Pain Interactions (G072323N)

The over-arching goal of this observational (case-control, with a cross-sectional and longitudinal arm) study is to comprehensively map stress system (dys)function (including reactivity and recovery) in people with primary musculoskeletal (MSK) pain and a pain-free control group. * The primary objective is to characterize stress systems functioning and their relation to pain in individuals with subacute versus chronic, and localized versus widespread MSK pain, and compare to pain-free controls. * The secondary objective is to define the contribution of stress system functioning to trajectories of MSK pain, including pain chronification or recovery from pain. Researchers will compare primary musculoskeletal pain groups with pain-free controls. Participants will: * Fill out online questionnaires. * Provide a sample of hair and saliva to assess chronic and acute stress hormone levels, respectively. Saliva samples will be collected both in the lab and at home. * Be subject to psychophysiological monitoring. * Partake in quantitative sensory testing measuring pain thresholds, tolerances and pain modulation of pressure and heat. These tests will be repeated twice: before and after an acute-stress induction task. * Partake in a series of stress-inducting tasks. * Be subject to MRI-scans of the brain, including structural and functional MR acquisitions (e.g., during rest and during pain inductions). Participants will be invited for a second session of the same assessments six months later to observe possible connection between pain trajectory and stress system (dys)function.

Pilates and Resistance Training for Pain, Disability, and Sleep in Chronic Low Back Pain

This study will investigate the effect of Pilates and resistance training on pain, disability, and sleep quality in patients with chronic low back pain and sleep disturbances. Participants will be randomly assigned into three groups: Combined intervention group: Pilates plus resistance training Single intervention group: Pilates alone Control group: Advices only All interventions will be delivered 3 times per week for 8 weeks, with outcome measures assessed at baseline, post-intervention (8 weeks), and follow-up (16 weeks). It is expected that the combined intervention group will show the greatest improvements in pain, disability, and sleep quality, while the single intervention group will demonstrate moderate benefits compared with usual care.

Assessment of Pain Perception and the Impact of Central Sensitization on Biopsychosocial Manifestations During Physical Activity in Patients With Chronic Low Back Pain

The goal of this prospective observational study is to evaluate changes in cognitive and behavioural markers associated with central sensitisation between the start and end of an exercise retraining programme on an exercise bike, in adult patients suffering from chronic lower back pain associated with an untreated degenerative spine, worth or without referred pain. The main changes it will evaluate are: \- Changes in cognitive and behavioural markers associated with central sensitisation between Day 0 and Day 40 during exercise retraining on an exercise bike as part of a rehabilitation programme for chronic low back pain Participants will undergo the followings: * A calibration test used to define moderate exertion on an ergocycle, corresponding to a perceived exertion of 4-5/10 on the modified Borg scale * Exercise-induced pain intensity assessment tests to detect changes in the intensity of pain during physical activity and the activity's potential to cause pain, realised on ergocyle * Exercise rehabilitation on an ergocycle * Final tests to assess cognitive and behavioural markers related to central sensitisation and pain intensity, as at baseline.

Effect of Alexithymia on Treatment Response to Transforaminal Epidural Steroid Injections in Chronic Low Back Pain

Low back pain and lumbosakral radiculopathy represent common clinical challenges substantially diminishing health-related quality of life and work productivity. Transforaminal Epidural Steroid Injection (TFESI) is widely performed in routine practice to reduce radicular pain, enhance functional capacity, and mitigate the need for surgery. However, clinical response to TFESI remains notably heterogeneous, indicating that biomedical parameters alone may not fully account for treatment efficacy and that psychosocial variables play a critical role. Alexithymia, defined as difficulty in identifying and describing emotions coupled with an externally oriented cognitive style, is prevalent among individuals with chronic spinal pain and linked to heightened pain perception and affective distress. This prospective observational cohort study aims to investigate the influence of baseline alexithymia levels (measured by the 20-item Toronto Alexithymia Scale \[TAS-20\]) on treatment response (defined as pain relief and functional improvement) following routine clinically indicated TFESI in patients with chronic low back pain and radiculopathy.

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.

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.

Durability of Yoga for Veterans With Low Back Pain

Chronic low back pain is a prevalent condition among VA patients, but many current treatment options have side effects or limited effectiveness. Veterans with chronic low back pain (cLBP) experience increased disability, functional challenges, and reduced quality of life. A prior VA funded study of Yoga for VA patients with cLBP found that yoga can reduce pain and disability at 3 and 6 months after enrollment. However, the long-term effects and maintenance of yoga practice is unknown. The current study will test an intervention designed to promote long-term yoga practice and long-term health outcome benefits at 12 and 18 months after enrollment.

Sensory Stimulation Belt for Chronic Low Back Pain in Office Workers

This randomized, double-blind, sham-controlled trial will evaluate the effectiveness of a sensory stimulation belt in office workers with chronic nonspecific low back pain. Participants will first complete baseline clinical and sensorimotor assessments and will then be randomly assigned in a 1:1 ratio to receive either an active sensory stimulation belt or a sham belt. Participants will wear the assigned belt during their usual office work for at least 4 hours per day, 5 days per week, for 4 weeks. Daily belt use, pain intensity, adherence, skin reactions, and device-related problems will be recorded in a study logbook, with weekly follow-up by the research team. Clinical outcomes will include pain intensity, frequency and intensity of low back pain or discomfort episodes, low back pain-related disability, work-related musculoskeletal discomfort, tactile acuity, and pressure pain threshold. Mechanistic outcomes will include corticospinal excitability, somatosensory cortical responses during unstable sitting, postural control, lumbar multifidus motor-unit behavior, and lumbar multifidus contractile response. The primary objective is to determine whether 4 weeks of active lumbar sensory stimulation produces greater improvements in clinical outcomes than a sham intervention and whether clinical changes are accompanied by changes in sensorimotor and neuromuscular outcomes.

Optimization of Lumbar Sensory Stimulation Parameters in Office Workers With Chronic Low Back Pain

This study aims to determine the optimal parameters of lumbar sensory stimulation in office workers with chronic nonspecific low back pain. Participants will attend two laboratory sessions. The first session will characterize baseline clinical and sensorimotor function using clinical assessments, transcranial magnetic stimulation, functional near-infrared spectroscopy during unstable sitting, inertial measurement units, decomposition electromyography, and rehabilitative ultrasound imaging. The second session will use a randomized within-participant crossover design in which participants receive eight combinations of lumbar vibration frequency, amplitude, and direction while bilateral primary somatosensory cortex hemodynamic responses are continuously measured using functional near-infrared spectroscopy. The primary objective is to identify vibration parameters that produce a favorable and consistent cortical response while meeting predefined comfort, safety, and technical criteria.

Treating Negative Affect in Low Back Pain Patients

This study will examine how the use of antidepressant, physical therapy, and combination of both affects pain, function, and depression outcomes in chronic low back pain patients.

Study of Correlation Between the Level of Intradiscal Periostin Expression and Pfirrmann Grading

Intervertebral disc degeneration (IVDD) is a well-recognized musculoskeletal condition that imposes a substantial socioeconomic burden and is an important cause of low back pain. IVDD can result from a variety of factors, including aging, obesity, genetic predisposition, degeneration of the multifidus and psoas muscles, osteoporosis, inflammation, and oxidative stress. The intervertebral disc (IVD) within the spine is composed of a gel-like nucleus pulposus (NP) at its center, a surrounding annulus fibrosus (AF), and cartilaginous endplates above and below. The NP and AF produce a water-rich extracellular matrix (ECM), which contributes to normal functioning of the spinal column. Various internal and external stimuli cause dysfunction of the NP and AF, and excessive metabolic activity of the endplates leads to endplate degeneration and calcification, ultimately resulting in disc degeneration. In addition to aging and mechanical overload, increased oxidative stress and inflammatory cytokine release further accelerate IVDD. Periostin is a component of the ECM that is associated with mechanical stress, inflammation, and aging, and has been closely linked to the development and progression of IVDD. Periostin binds to ECM molecules within the IVD and is involved in disc maintenance and repair; however, excessive ECM turnover induces and accelerates disc degeneration. Periostin affects IVD degeneration through pathways related to mechanical stress and inflammation, and serum periostin levels have been reported to be elevated in patients with more advanced disc degeneration. A recent study demonstrated a strong correlation between serum periostin concentration and the Pfirrmann grading system. However, measuring periostin concentration through blood sampling has limitations, as serum periostin levels can also increase similarly in patients with a history of head and neck cancer or allergic disease. Therefore, it is necessary to directly assess the degree of periostin expression within the intervertebral disc itself and to determine whether it shows a meaningful correlation with the Pfirrmann grading system. In addition, periostin is known to be more abundant in the AF than in the NP, but this has not previously been demonstrated through actual staining of disc tissue; this study therefore aims to compare the degree of periostin expression between the NP and AF using immunohistochemical staining. Pfirrmann et al. developed a reliable, MRI-based grading system that is the most commonly used method for evaluating IVDD. The Pfirrmann grading system is based on analysis of T2-weighted MR sagittal images of the IVD, incorporating disc homogeneity, morphology, the distinction between the AF and NP boundary, T2 signal intensity, and disc height.

Prospective Case Series Evaluating 6-Month and 12-Month Outcomes After Cryoneurolysis for Chronic Pain

To prospectively describe patient-centered and health utilization outcomes through 12 months after cryoneurolysis performed as routine clinical care for chronic pain at Yale.