Clinical Research Directory

Assess the Effectiveness of Pulse RadioFrequency in Patients With Chronic Lumbar Radicular Pain

Pulsed RadioFrequency (PRF) is a relatively new technique derived from a well established and proven intervention, thermal radiofrequency (RF). Both procedures are used in the treatment of chronic pain. Unlike RF treatment, PRF does no direct damage to the nerve. During PRF treatment, electrical energy is applied with a small needle to the affected nerve using a pulsed time cycle that delivers short bursts of RF current. This study is interested in looking at the efficacy of PRF for chronic lumbar radicular pain (CLR) and to assess whether a larger scale clinical study with the same methods can be used.

Generate and Test the Reliability of a PD Model of OXT on Pupillary Hippus as a Measure of CNS Activity

The purpose of this research is to evaluate the effects of oxytocin (naturally occurring hormone) given by an intramuscular (IM; into the muscle) injection, has on your parasympathetic nervous system. The parasympathetic nervous system is the part of the involuntary nervous system that is sometimes called the "rest and digest" system; the parasympathetic system conserves energy as it slightly slows the heart rate, increases intestinal and gland activity, and relaxes sphincter muscles in the gastrointestinal tract.

NonNarcotic Pain Control in Percutaneous Needle Tenotomy of Elbow

This study is a double-blind, randomized controlled trial comparing the effectiveness of oral acetaminophen, diclofenac, and tramadol in reducing the consumption of narcotic doses (primary outcome) and minimizing patients' exposure to narcotics (secondary outcome) following an ultrasound-guided percutaneous needle tenotomy procedure on the lateral elbow.

Pain Reprocessing Therapy (PRT) in a Specialist Pain Clinic: A Feasibility Study

Long-term pain, which is pain that lasts for more than three months, is a major health problem. It can severely impact a person's physical and mental well-being, quality of life, and ability to work. It also carries high costs for society, mainly due to high rates of sick leave. For many people with long-term pain, there is no clear injury or disease that fully explains why it hurts. In these cases, the pain is believed to be caused by how the brain and nervous system process pain signals. This is sometimes called "nociplastic pain." Even though there are many treatments for pain-like medications and therapies-they don't work for everyone, and many people are left without meaningful relief. Because of this, it is important to find and test new ways to treat pain. In this study, the investigators evaluate a relatively new psychological treatment called Pain Reprocessing Therapy (PRT), which has been tested in the US with promising results. PRT helps individuals with chronic pain to understand and change how they think about their pain by explaining how the brain works. The treatment focuses on teaching the difference between acute (new) pain and long-term pain. It also involves exercises to help people alter emotions related to their pain. A key part of the treatment is a technique where patients practice paying attention to what is happening in their bodies in a safe, relaxed way. The goal is to teach the brain that the pain signals are not a threat. This can help break the vicious cycle of fear, avoiding activities, and worsening pain. While many people are interested in treatments like PRT, it hasn't yet been tested in specialized care for patients with complex pain. This trial is a pilot study-a smaller, initial investigation to evaluate how well the treatment works in a clinical setting, and to determine if both patients and therapists find it acceptable and practical to use. This will give us important information to help prepare for larger studies in the future. The main goal of this pilot study is to see if PRT is a practical and accepted treatment in a Swedish pain rehabilitation setting. The investigators also want to look at whether the treatment helps reduce pain, psychological distress, negative thoughts about pain, and the fear of moving. Finally, the investigators will explore how a patient's expectations and thinking skills (such as memory and focus) might affect how well the treatment works, and take physical measurements before and after the treatment to see if the nervous system becomes better at regulating pain.

Group Music Therapy for Chronic Pain Management in Active Duty Service Members

This randomized controlled trial will evaluate the effectiveness of an 8-week group music therapy intervention for active duty service members with chronic pain. Participants will be randomized to either a group music therapy intervention plus standard care or standard care alone. Outcomes will be assessed at baseline, post- treatment (8 weeks), and 1-month follow-up. Primary outcomes include pain interference and pain intensity. Secondary outcomes include pain-related self-efficacy, depression, anxiety, positive affect, sleep disturbance, patient perception of change, and pain medication use. Qualitative interviews will be conducted with a subset of participants who receive music therapy to explore subjective experiences and perceived treatment benefits.

Clinical Utility of Neurophysiological Measurements of ECAP-controlled Closed-loop SCS to Guide Treatment of Chronic Pain

The purpose of this study is to evaluate the clinical utility of neurophysiological measurements of ECAP-controlled closed-loop SCS (i.e., neural panel metrics) to guide treatment of chronic pain of the trunk and/or limbs.

Managing Chronic Tendon Pain by Metformin

The purpose of the current exploratory clinical trial is to determine the effect of oral ingestion of metformin (OIM) in non-diabetic patients with chronic Achilles tendon pain. The trial has two aims; 1) to assess the effects of OIM treatment on tendon pain, and 2) to determine the effects of OIM capsules on tendon healing and repair. Twenty participants will be treated with metformin capsules for 16 weeks combined with a home exercise program. A comparison group of 20 participants will be treated with placebo tablets along with home exercise program.

Mindfulness-Based Intervention for Pain and Sleep in Adolescents and Young Adults With Sickle Cell Disease

This study examines the feasibility and acceptability of a mindfulness-based mobile intervention designed to support pain and sleep management among adolescents and young adults with sickle cell disease. Chronic pain and sleep problems are common in this population and can negatively affect daily functioning and quality of life. Participants will use a smartphone-based mindfulness program that includes structured modules and guided mindfulness exercises over an approximately 8-week period. The study aims to evaluate whether the intervention is feasible and acceptable for adolescents and young adults with sickle cell disease.

Comparing the Effects of Yoga Nidra to Yoga Nidra With Pain Acceptance Intention and Motor Imagery on Pain Outcomes

Yoga Nidra is a scripted mind-body intervention (MBI) that uses guided relaxation technique in a reproducible sequence of mechanisms that naturally produce a parasympathetic response. This is a randomized controlled trial in which participants will be randomly assigned to one of three interventions: 1) yoga nidra (Yoga Nidra Script Basic), 2) yoga nidra with pain acceptance (Yoga Nidra Acceptance Intention), 3) yoga nidra with pain acceptance and Explicit Motor Imagery (Yoga Nidra Acceptance Intention and Visualization).

Effects of Exercise Snacking on Physical Fitness, Cognition, and Pain in Institutionalized Older Adults

This study aims to compare the effects of two different exercise approaches on health and well-being in older adults living in residential care facilities. One approach, called "exercise snacking," consists of short and frequent bouts of physical activity spread throughout the day, while the other involves longer, structured exercise sessions performed a few times per week. Approximately 75 adults aged 65 years and older will be randomly assigned to one of the two exercise programs and will participate for 12 weeks. The study will examine whether exercise snacking is as effective as conventional exercise in improving physical fitness, cognitive function, chronic pain intensity, quality of life, and symptoms of anxiety and depression. The researchers hypothesize that short, intermittent exercise sessions may provide similar or greater health benefits compared to traditional exercise programs and may represent a practical and accessible strategy to promote physical activity in older adults living in institutional settings.

Full-Spectrum Cannabis Extract for Chronic Pain and Bone Health Biomarkers in Women

Chronic pain disproportionately affects women and may coexist with impaired bone health, particularly during midlife and after menopause. The endocannabinoid system is involved in pain modulation and bone homeostasis; however, clinical studies that integrate pain outcomes, bone-related biomarkers, genetic variants, and salivary endocannabinoids remain limited.This randomized, triple-masked, placebo-controlled crossover trial will evaluate the effects of a full-spectrum medicinal cannabis extract with a cannabidiol to tetrahydrocannabinol ratio of 5:1 on chronic pain in women aged 45 to 80 years with chronic pain refractory to conventional treatment. Eighty participants will be randomly assigned to one of two treatment sequences: full-spectrum cannabis extract followed by matching placebo, or matching placebo followed by full-spectrum cannabis extract. The treatment periods, washout interval, and visit schedule will follow the final approved protocol.The primary outcome is change in chronic pain intensity measured using the Visual Analog Scale. Secondary outcomes include quality of life, sleep quality, functional impact, bone health biomarkers, bone mineral density measured by dualenergy X-ray absorptiometry, salivary endocannabinoids, the association of CB and TRPV genetic variants with treatment response, and adverse events. The study aims to generate evidence on the clinical effects and biological correlates of medicinal cannabis therapy in women with chronic pain.

RCT of a Weighted Blanket to Reduce Pain in Veterans With Chronic Pain

Chronic pain is a major health concern for returning Veterans and is associated with decreases in quality of life. In addition, chronic pain is often accompanied by significant disturbance in sleep. Sensory interventions may offer effective, low-cost complementary tools for chronic pain and sleep disturbance in Veterans. Weighted Blankets (WB)- blankets sewn with weighted material inside to provide widespread pressure to the body- are a low-cost wellness product used for anxiety and sleep. WBs have demonstrated large reductions in insomnia, and the investigators have also shown that they can reduce the severity of chronic pain. However, effects and mechanisms of longer WB use have not been examined in individuals with pain and sleep disturbance. The investigators therefore propose a randomized controlled trial examining the effects of WBs on pain and sleep quality in Veterans. the investigators will recruit Veterans with chronic pain and sleep disturbance from the VA San Diego Healthcare System (VASDHS) and VA San Francisco Healthcare System (VASFHS) and randomize 160 Veterans to receive either a light (3-lb; N = 80) or heavy (15-lb; N = 80) blanket. The investigators will remotely collect measures of pain (primary), pain catastrophizing, and pain medication use, as well as sleep disturbance (primary) and sleep efficiency and total sleep time over 6 weeks of overnight home use of the assigned blanket. The investigators will also explore physiological effects of WBs on sleep quality using actigraphy (exploratory) in VASDHS participants. Ecological momentary assessment (EMA) methods will be deployed via smartphone to capture study adherence.

Hyperbaric Oxygen Therapy in Complex Regional Pain Syndrome

The aim of the study is to investigate the efficacy of hyperbaric oxygen therapy as an adjunct in the management of severe complex regional pain syndrome.

Mindfulness-Based Cognitive Therapy Vs. the Health Enhancement Program for Chronic Pain and Early Cognitive Decline; The Feeling of Being Pilot RCT

The goal of this clinical trial is to pilot a randomized controlled trial comparing an adaptation of mindfulness-based cognitive therapy to the health enhancement program for chronic pain and early cognitive decline. The main questions it aims to answer in a later fully powered randomized controlled trial are: * Is an adaptation of mindfulness-based cognitive therapy for older Black adults able to improve quality of life? * Will an adapted mindfulness based cognitive therapy reduce pain interference to a greater degree than a traditional health enhancement program?

Mindfulness for Pain and Suicide

The proposed study will assess the feasibility and acceptability of a mindfulness-based intervention to reduce functional impairment from chronic pain and risk of suicide.

Outpatient Midline Catheter in Patients Receiveing Lidocaine Infusion Series.

This study will assess the efficacy, safety and practicality of using midline catheters for repeated intravenous lidocaine infusions in an outpatient pain management setting. Adult patients requiring serial lidocaine infusions for chronic pain will be enrolled and receive treatment through midline catheters over ten sessions. The study will investigate if the midline catheters are a safe and effective option for delivering repeated lidocaine infusions in the outpatient setting, offering a balance between ease of placement, acceptable complication risk and good patients' comfort.

Mindfulness-based Cognitive Therapy vs the Health Enhancement Program for Chronic Pain and Depression; The Quiet Focus Study

The goal of this clinical trial is to pilot a randomized controlled trial comparing an adaptation of mindfulness-based cognitive therapy to the health enhancement program for chronic pain and depression. The main questions it aims to answer in a later fully powered randomized controlled trial are: * Is an adaptation of mindfulness-based cognitive therapy for older Black adults able to improve quality of life? * Will an adapted mindfulness based cognitive therapy reduce pain interference to a greater degree than a traditional health enhancement program?

Action Observation and Motor Imagery Training in Cervical Disc Herniation

Cervical disc herniation is a common degenerative spinal disorder associated with chronic neck pain, impaired cervical function, reduced motor control, and decreased quality of life. Although conventional physiotherapy is widely used, innovative rehabilitation strategies that enhance motor learning may improve treatment outcomes. This randomized controlled trial aims to investigate the clinical effectiveness of Action Observation (AO) and Motor Imagery (MI) training as an adjunct to conventional physiotherapy in individuals with cervical disc herniation and chronic neck pain. Thirty-six participants diagnosed with cervical disc herniation will be randomly assigned to one of two groups. The control group will receive conventional physiotherapy combined with sham observation consisting of neutral nature videos, while the experimental group will receive conventional physiotherapy plus AO and MI training. The intervention period will last six weeks. Clinical outcomes will be assessed before and after the intervention. Primary and secondary outcome measures will include pain intensity, pressure pain threshold, neck disability, kinesiophobia, cervical motor control and endurance, and cervical proprioception using validated assessment tools. The findings of this study are expected to provide evidence regarding the effectiveness of AO and MI training as complementary rehabilitation approaches for individuals with cervical disc herniation and to support the integration of motor learning-based interventions into clinical physiotherapy practice.

Tapentadol vs Tramadol in Arthroscopic Rotator Cuff Repair

Compare the effectiveness of tapentadol and tramadol as part of a multimodal analgesia treatment for Arthroscopic Rotator Cuff Repair Surgery.

A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Chronic Low Back Pain

The main purpose of this study is to test the safety and efficacy of study drug for the treatment of chronic low back pain (CLBP). This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292), which is a protocol to accelerate the development of new treatments for chronic pain.

National Survey of Chronic Occupational Pain in Thai Anesthesia Providers

The purpose of this nationwide cross-sectional survey is to determine the prevalence, multidimensional impacts, and associated factors of chronic occupational pain among anesthesiologists and nurse anesthetists in Thailand. Due to the physically demanding nature of anesthesia practice-such as prolonged standing, awkward postures during airway management, and high-stress environments-work-related musculoskeletal disorders are highly prevalent but often underreported. This study aims to collect self-reported data via an anonymous online questionnaire to assess pain severity, specific anatomical locations, economic burdens (including absenteeism and presenteeism), and the overall impact on the health-related quality of life. Ultimately, the findings from this study will help establish a national evidence-based database to improve workplace safety, inform occupational health policies, and enhance the overall well-being of anesthesia providers in Thailand.

A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Osteoarthritis Pain

The main purpose of this study is to test the safety and efficacy of study drug for the treatment of knee pain due to osteoarthritis (OA). This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292), which is a protocol to accelerate the development of new treatments for chronic pain.

Prospective Assessment of Integrative Therapies for Neuromusculoskeletal Pain (PAIN)

With vast numbers of active-duty members restricted from their specific duties or deemed unfit for deployment because of low back pain, both the mission of the Department of Defense and overall military workflow can be significantly impacted. More than restriction from duty or being barred from deployment, studies have shown musculoskeletal conditions were among the top reasons for medical disability retirement in the Army and Marine Corps (Niebuhr; Sikorski). Given the significant time, money, and resources invested in training these members, each day of inactivity or disability detrimentally affects the execution of the military's mission. Therefore, precise diagnosis and effective treatment modalities are paramount to foster healing and reduce recovery time. From an operational standpoint, the United States Department of Defense (DoD) is specifically interested in using tailored integrative medicine modalities to manage chronic conditions encountered in the military health system. Not just chronic pain, but polytrauma and the triad of conditions it encompasses; traumatic brain injury and post-traumatic stress disorder combined with chronic pain (Madsen, Kim, Bedard). The DoD's goal is also to decrease opioid prescribing and the addiction and altered state associated with opioids. AT the Nellis Integrative Medicine Clinic, physicians, a chiropractor, and nurses are engaged in the treatment of patients. All personnel are trained in the various modalities available in the clinics. A variety of modalities are utilized in the clinic. This prospective study will evaluate the effectiveness of the many modalities used in the Integrative Medicine Clinic (such as acupuncture, myofascial therapies, microcurrent therapies, LASER therapy, extracorporeal shockwave therapy, and pulsed electromagnetic therapies). Most patients receive treatments using multiple modalities. DoD goals align with our experiences in the Integrative Medicine Clinic at Mike O'Callaghan Military Medical Center. Many servicemembers and dependents in our clinic are trying to avoid surgery, or their pain medications - opioid or not - are no longer working. Additionally, many patients are trying to avoid Do Not Fly status caused by pharmacologic approaches. Patient experiences at our IMC also correlate with a study where 80% of people surveyed felt integrative medicine should be routinely offered at all MTFs (Ross). While our patients generally are not on opioids, we have anecdotally noted a reduction or cessation of opioids in several patients. The impacts of such a reduction in opioid usage for military readiness is clear (Madsen).

Targeted Realtime Assessment of Chronic Pain in Youth

The purpose of this study is to evaluate the feasibility and acceptability of using wearable digital health technology for continuous monitoring of physiological, sleep, and physical activity data in adolescents with chronic musculoskeletal (MSK) pain. This research aims to develop objective digital endpoints of the pain experience to improve diagnosis, prevention, and treatment outcomes.