Clinical Research Directory

MOTIVATE to Improve Outcomes for Older Veterans With Musculoskeletal Pain and Depression

The proposed study seeks to evaluate effectiveness, implementation processes, and cost of MOTIVATE among older Veterans with chronic musculoskeletal (MSK) pain and comorbid depressive symptoms.

Compex SP8.0 - Symptomatic Treatment of Musculoskeletal Pain

This post-market clinical study of the SP8.0 Compex device aims to comprehensively assess the safety and performance of the device when used in accordance with the approved Instructions for Use. The results of this study will also support the clinical evaluation of the next-generation wireless product currently under development. The Compex Consumer devices contain different programs, such as conditioning, fitness, recovery, massage, rehabilitation, and pain management. This study will utilize the Compex SP 8.0 pain management programs, with the aim of assessing the effectiveness of the treatment provided by the device in managing pain through different physiological mechanisms.

A Pragmatic Trial of EAET for Veterans With Chronic Pain

About one in three Veterans lives with long-term (chronic) pain, and many of them also struggle with past trauma and mental health issues like depression, anxiety, or PTSD. Emotional Awareness and Expression Therapy (EAET) is a type of talk therapy that helps people understand and express their emotions, especially those linked to past trauma. This therapy has been shown to help reduce pain and improve mental health. So far, multiple studies have tested EAET in both Veterans and civilians, and the results have been promising. EAET has helped people feel less pain, move better, and experience fewer mental health symptoms. Because of these strong results, the U.S. Department of Health \& Human Services named EAET a Best Practice for managing pain in 2019. Two earlier studies at a VA hospital in Los Angeles found that EAET worked even better than another well-known therapy called cognitive behavioral therapy for chronic pain (CBT-CP) for older Veterans. However, those studies were done in tightly controlled settings. Now, researchers want to see if EAET works just as well when it's used in everyday healthcare settings, by different types of doctors and therapists. Doctors and therapists at up to 7 VA hospitals across the country will be trained to use EAET. They will then try it out with Veterans to see how well it works and how easy it is to use in real clinics. Veterans, doctors, and other staff will be asked for feedback to learn what helps or gets in the way of using EAET.

Examining the Effectiveness of Ergonomics and Exercise Training in Caregivers

Family and formal caregivers of partially or fully dependent individuals repeatedly perform physically demanding tasks such as lifting, transferring, repositioning, and hygiene care. These tasks increase biomechanical loading and place caregivers at high risk of musculoskeletal complaints, which in turn increase perceived caregiver burden, burnout, and fatigue. Interventions for this population have most often been limited to information leaflets or theoretical instruction, and the active exercise component has usually been absent. Furthermore, teaching safe transfer techniques alone may be insufficient when caregivers lack the muscle strength, trunk (core) stability, and flexibility required to perform those techniques.

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.

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.

Empowered Relief for Caregivers

This study is testing a new program called Empowered Relief for Caregivers (ER-CY), designed to support caregivers of children and teens who live with chronic pain. ER-CY is a single two-hour class delivered online. It teaches skills for managing the stress of caring for a child in pain and for responding to a child's pain in helpful ways. Up to 80 caregivers of youth with chronic pain will take part in one ER-CY class and then complete surveys and a short interview over the following three months. The researchers want to learn two things: whether caregivers are willing and able to take part and find the program helpful and satisfying, and whether the program lowers caregiver distress and improves their child's day-to-day functioning. What is learned will help guide future programs and care for youth with chronic pain and their families.

Video Intervention for Older Adults With Chronic Pain

Chronic musculoskeletal (MSK) pain, which includes spinal pain, osteoarthritis, and fibromyalgia, is a common and costly problem for older adults and is associated with decreased quality of life. In this project, investigators propose to create Reclaim Your Day (RYD), which will consist of 6, 30-min weekly video episodes highlighting patients' inspiring and illustrative experiences living with chronic pain in order to teach current patients with chronic MSK pain how to apply ACT's evidence-based strategies. INvestigators will conduct a pilot RCT (n=100) of older adults with chronic MSK pain. All participants will receive an introductory pain education video. Participants will be randomized to receive either RYD or a comparison intervention (health education videos). Investigators will examine RYD feasibility and acceptability as well as changes over time in outcomes (pain interference, depression, quality of life) and putative mediators.

A Controlled Study to Evaluate the Effects of a Topical Cream on Symptoms of Arthritis, Joint, and Muscle Pain

This is a randomized, triple-blind, controlled clinical trial evaluating the effects of Saje Pain Release Joint \& Arthritis Cream on symptoms of arthritis, joint pain, and muscle pain in adults aged 20-65. The trial is conducted virtually over seven days, with 80 participants randomized equally into an intervention arm (active topical cream) and a control arm (matched control product). Participants apply their assigned product three times daily to affected areas (knees, elbows, wrists, or ankles) and complete questionnaires at Baseline, 30 minutes after the first application, and at the end of Day 7. The primary objective is to assess changes in arthritis and musculoskeletal pain symptoms, while secondary objectives assess participants' perceptions of joint pain, stiffness, function, comfort, flexibility, mobility, and overall quality of life.

Comparison of Eccentric Muscle Training and Proprioceptive Neuromuscular Facilitation Techniques in Neck Pain

This trial compared eccentric exercise training and the proprioceptive neuromuscular facilitation (PNF) technique, each added to a common cervical stretching and stabilisation programme, in individuals with non-specific neck pain. Outcomes were neck-related disability, multidimensional pain, cervical range of motion, deep cervical flexor endurance, kinesiophobia and health-related quality of life, assessed at baseline and after 6 weeks.

Multimodal Management of Neck and Back Pain in the Emergency Department (Multi-ED)

The purpose of this study is to assess the feasibility and acceptability of psychologically-informed physical therapy (PIPT) in the ED in a pilot study of ED patients with neck or back pain. We will conduct a single-site, prospective trial comparing the combined program in one group with a usual care-only group. Primary outcomes will focus on feasibility based on recruitment and retention rates, and acceptability based on a 5-point patient satisfaction scale, while secondary outcomes will include pain severity, pain interference, anxiety, physical function, opioid use, repeat ED visits, and hospitalizations at 1 hour and at 24 hours, 1 month and 3 months after ED discharge. We will use pilot study results to develop a protocol for a larger pragmatic randomized clinical trial designed to rigorously evaluate PIPT in the ED combined with Spine Health follow up for ED patients with neck or back pain. We will perform a process evaluation of our proposed clinical trial study design, including characterizing and quantifying the degree of CBT and PT components used by treating PTs while in the ED and during Spine Health follow up, number of Spine Health visits attended in the first month, and integration into usual ED care. Qualitative interviews will be used to identify facilitators, barriers and potential solutions to intervention and research study procedures based on the patients' experience.

Effectiveness of Health Education Program on Musculoskeletal Pain Management in Primary School Students

Musculoskeletal pain during childhood can negatively affect school attendance, physical activity, and social participation. This study will evaluate the effectiveness of the school-based health education program 'SocLaLola', which uses a comic-based narrative to introduce children to pain science concepts and promote healthy lifestyle habits. The intervention will be compared with a standard program focused on sedentary behavior prevention. Students aged 8 to 11 years from two primary schools will participate. The primary objective is to determine whether SocLaLola is more effective than the comparison program in improving children's knowledge about pain and in reducing fear-avoidance beliefs related to physical activity.

Kinesiotaping Versus Physiotherapy for Post-Covid-19 Back Pain

Objective: This study aims to compare and evaluate the effectiveness of kinesiotaping and traditional physiotherapy methods, which are frequently used in the treatment of musculoskeletal diseases, on mid-back pain (MBP) developed after COVID-19. Study Design and Methods: Patients aged 18 or older who have been diagnosed with COVID-19, have completed their medical treatment, and whose isolation period has ended are included in the study. The patients' age, sex, and body mass index (BMI) are recorded. The participants are assigned to receive one of two interventions. In the first group, kinesiotapes are applied and left on the patient's back for a total of 10 days. The second group is treated with traditional physiotherapy methods, specifically Vacuum Interferential Current Therapy and Hot Pack Therapy. Clinical evaluations are performed using the Visual Analogue Scale (VAS), Pain Quality Assessment Scale, LANSS Neuropathic Pain Scale, and Nottingham Extended Activities of Daily Living Index. Measurements are taken at two time points: baseline (pre-treatment) and at the end of the 10th day (post-treatment).,

Work And Vocational advicE Study - Effectiveness of Adding a Brief Vocational Support Intervention to Usual Primary Care

Maintaining the population's fitness for work is a priority for the UK Government. People with poor health often struggle at work and take sick leave. Work brings financial, social and health benefits. Few employees receive support to manage their health at work, known as vocational advice, so when their health affects work they visit their general practitioner (GP). The investigators have recently shown the benefits of providing vocational advice for adults consulting in primary care with musculoskeletal pain. The WAVE study research question is: in patients consulting in general practice who receive a fit note for time off work, does a brief vocational advice intervention lead to fewer days lost from work than usual primary care, and is it cost-effective? WAVE includes a feasibility phase to adapt a vocational advice intervention for a broader group of patients and test it in a small sample of patients; followed by a pragmatic, multi-centre, two-arm, parallel-group randomised (1:1) trial with internal pilot phase, mixed methods process evaluation and health economic analysis. Patients will be randomised to either (i) vocational advice intervention plus usual care, or (ii) usual care alone. The vocational advice intervention is designed as a stepped care model based on the principles of case management and delivered by trained Vocational Support Workers (VSWs). The investigators will also interview patients, General Practitioners (GPs), VSWs and employers to understand their views about the intervention and return to work. Participants in the trial will be followed-up over 6 months with fortnightly text messages and postal questionnaires at 6 weeks and 6 months.

Virtual Reality (VR) Self-Hypnosis Software

This single-site study of self-hypnosis software using an off-the-shelf virtual reality (VR) device (OculusGo™) to determine the software's safety, usability, and preliminary efficacy in pain relief for HIV-associated chronic pain patients. This is funded under the i Prism Funding through Mount Sinai Innovations.

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.

Regenerative Medicine for Joint Hypermobility and Instability

This clinical trial is designed to evaluate whether a stepwise injection-based treatment approach can reduce pain and improve function in adults with joint hypermobility, connective tissue laxity, and joint instability. Joint hypermobility occurs when joints move beyond their normal range, often because of looser connective tissue. For some patients, this can contribute to chronic pain, recurrent instability, reduced function, and disability. This study focuses on adults with hypermobile Ehlers-Danlos syndrome (hEDS), hypermobility spectrum disorder (HSD), or joint instability after injury who have already completed physical therapy without adequate relief. The main question this study aims to answer is whether the first treatment step, dextrose prolotherapy, can reduce pain by 40% or more two weeks after the second injection. Participants will receive treatment in a step-by-step sequence, based on their response: Step 1: Dextrose prolotherapy A dextrose-based injection used to stimulate a healing response in ligament, tendon, or joint-supporting tissue. Step 2: Platelet-rich plasma (PRP) An injection prepared from the participant's own blood, designed to support tissue repair and recovery. Step 3: Doxycycline injections A low-dose injectable treatment used in this study to help protect joint-supporting tissue. It is not being used to treat infection. Alternative option: Hyaluronic acid injections An injection into the joint that may be offered if the earlier treatment steps do not provide enough improvement. Each treatment step begins with two injections, given approximately two weeks apart. If a participant improves by 40% or more, they may continue with that treatment pathway. If they do not improve enough, they may be offered the next step in the study. Participants will be followed for up to 12 months, with study visits used to monitor pain, function, treatment response, and safety.

Using the Cholinergic Anti-Inflammatory Pathway to Treat Systemic Lupus Musculoskeletal Pain

Systemic Lupus Erythematosus (SLE) is a chronic autoimmune, inflammatory disease and musculoskeletal pain is one of the most common symptoms. This study will investigate whether transcutaneous stimulation of the vagus nerve will decrease lupus musculoskeletal pain. This study will additionally investigate the biologic effects of vagus nerve stimulation on inflammation. It will be the first clinical study using one of the body's own pathways of modulating the immune system and inflammatory response, the cholinergic anti-inflammatory pathway, in SLE.

Mechanisms and Modulation of Pain Modulatory Capacity

This project proposes to understand the sources of pain variability, and demonstrate that pain variability represents fluctuation in natural pain management. The project further proposes to determine if endogenous capacity to modulate pain can be trained to maximize their body's ability to manage pain, much as the way in which athletic performance can be trained.

Living in Full Even With Pain Study

This project will increase our understanding of the mechanisms underlying changes in opioid medication use associated with three psychosocial chronic pain (CP) treatments. These treatments are: (1) Cognitive Therapy (CT), (2) Mindfulness Meditation (MM), and (3) Behavioral Activation (BA). The sample will be adults with CP who are at risk of opioid misuse. The purpose of this study is to understand the specific ways these treatments work for reducing opioid use. In addition, the investigators are interested in examining moderators of treatment response. The findings will potentially inform the future streamlining of psychosocial treatments, as well as the development of algorithms for matching individuals with CP who are at risk for opioid misuse to the specific treatment most likely to efficiently optimize benefit.

Combined Physical Activity and Education Intervention for Neck and Shoulder Pain in Children

Neck and/or shoulder pain is increasingly reported among school-aged children and may affect their physical activity, daily life, psychological well-being, and quality of life. This study aims to evaluate the effects of a school-based physical activity and education intervention on neck and/or shoulder pain and related health outcomes among primary school children in Shijiazhuang, China. Participants will be primary school children aged 10 to 12 years. They will be allocated to one of four groups: a physical activity group, an education group, a combined physical activity and education group, or a control group. The intervention will last for six weeks. The physical activity intervention will include structured game-based activities and neck-shoulder exercises, while the education intervention will include health education related to posture, screen use, physical activity, and pain prevention. The study will assess changes in neck and/or shoulder pain, pain intensity, physical activity, sedentary behavior, sleep quality, psychological factors, quality of life, and physical activity enjoyment before and after the intervention.

Multidisciplinary Health Monitoring for Esports Players

This study aims to develop a holistic, multidisciplinary health monitoring/screening module that evaluates the health and performance parameters of esports players, and to apply and assess the effectiveness of an individualized multidisciplinary preventive intervention program (PIP) based on the screening findings. Esports players are frequently exposed to prolonged sitting, repetitive movements, high screen time, and irregular lifestyle habits, which can lead to musculoskeletal problems, visual strain, increased cardiovascular load, sleep disturbances, and psychological effects. Comprehensive, systematic, and multidisciplinary screening models addressing these risks remain limited in the literature. Amateur and/or professional players from the Yeditepe University Esports Club will undergo a multidimensional baseline assessment covering cardiovascular and respiratory parameters, musculoskeletal analysis, visual strain, nutritional status, cognitive function, and mental status. Participants will then be allocated to a control group or an intervention group. The intervention group will complete a 12-week individualized preventive exercise protocol in addition to their usual training, while the control group continues their usual training routine. All measurements will be repeated after 12 weeks to evaluate the effectiveness of the program.

Weighted Blanket Use for Adults With Chronic Pain

Chronic pain is a common condition that can affect sleep, daily functioning, and overall quality of life. Many individuals living with chronic pain seek non-medication approaches to help manage their symptoms. Weighted blankets are commonly used to promote relaxation and comfort during sleep, but there is limited research examining their potential role in supporting people with chronic pain. This pilot study will explore the experiences of adults with chronic pain who use a weighted blanket during sleep. The study aims to better understand whether nightly use of a weighted blanket may be associated with changes in pain, sleep, and daily functioning. Findings from this study will help inform future research on non-medication approaches to managing chronic pain. Approximately 44 adults with chronic pain will participate in the study. Participation will last about five weeks. After completing a virtual enrollment visit and baseline questionnaires, participants will receive a weighted blanket sized to approximately 10 percent of their body weight. Participants will first complete a 7-day adjustment period using the blanket while sleeping. If they tolerate the blanket and use it nightly during this period, they will continue into a 4-week study phase in which they will use the weighted blanket each night. During the study, participants will complete brief online surveys about their experiences and adherence to using the blanket. Pain and quality-of-life questionnaires will be completed at multiple time points, including at the start and end of the study. Participants will also provide feedback about their experience using the weighted blanket. Results from this pilot study will help researchers better understand how weighted blankets may be used by adults with chronic pain and may help guide the design of future studies evaluating non-pharmacologic approaches to pain management.

Symptom Severity, Posture, Pain, and Physical Activity in Gastroesophageal Reflux Disease

This study is a cross-sectional research designed to investigate symptom severity, posture, musculoskeletal pain, and physical activity levels in individuals with gastroesophageal reflux disease (GERD).