Clinical Research Directory

Soft Active Back Exosuit to Reduce Workplace Back Pain

The goal of this clinical trial is to determine if a wearable back exosuit can make it safer and easier for workers who bend, lift, and lower objects in an industrial setting. Many studies have shown that wearable back exoskeletons or exosuits can provide helpful forces making a person's back muscles work less. It is believed that exosuits can lower a person's level of workplace effort and fatigue, making it less likely for them to have back pain at work. Back exosuits could be a solution to make a job easier, but how well they work in the real-world over a long period of time is unclear. The investigators want to know if workers who wear a back exosuit during the workday will have lower rates of lower back pain or injury than those who are not wearing a back exosuit. The investigators also want to know how well exosuit technology integrates into the workplace (for example, how this technology improves or hinders job performance). Participants will be randomized into an exosuit group or control group. Participants in the exosuit group will be given a back exosuit that they can use as much as they want at work. All participants will complete surveys monthly. Researchers will compare the exosuit group to the control group to see if using a back exosuit in a workplace can reduce a person's risk and impact of low back injury or pain. The investigators also want to see if a back exosuit impacts job productivity and if participants find the exosuit becomes useful or bothersome over time.

Effects of a Four-Week Active Break Program on Musculoskeletal Pain and Spinal Mobility in Office Workers

This study was designed as a two-arm, parallel-group randomized controlled trial with a 1:1 allocation ratio. A total of 55 office workers were randomly allocated to an experimental group (n = 28) or a control group (n = 27). The experimental group participated in a four-week active break program, while the control group received no intervention. Participants in both groups were instructed to maintain their usual daily activities, ergonomic setups, and health routines throughout the study. The study aimed to investigate the effects of a brief daily active break program on subjective musculoskeletal pain and spinal mobility in office workers. Assessments were conducted at baseline, after two weeks, and after four weeks to evaluate changes over the study period.

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.

Impact of Mesenchymal Stem Cells in Knee Osteoarthritis

Many patients with osteoarthritis of the knee fail non-operative measures and elect to have knee arthroplasty to improve their quality of life. If successful, intra-articular mesenchymal stem cell (MSC) injections into the knee may offer another viable non-operative treatment modality. Additionally, this modality may have reparative or regenerative potential, which could lead to the first treatment for osteoarthritis that treats the underlying disease as opposed to symptomatic control. Additionally, there are no acceptable non-surgical treatments for focal chondral defects of the knee. Surgical treatments that do exist have diminished outcomes if performed on patients older than age 30-40 years. If successful, intra-articular MSC injections into the knee would represent the first non-operative treatment for focal chondral defects and also represent a potential option for treatment in patients over the age of 30-40 years. This trial will be a prospective, single-center phase I pilot study to evaluate the safety and tolerability of a single intra-articular injection of autologous bone marrow-derived MSCs in 16 subjects, 8 who have knee osteoarthritis and 8 who have a focal chondral defect in the knee. Patients will undergo a bone marrow harvest procedure at the Dahms Clinical Research Unit (DCRU) of University Hospitals Cleveland Medical Center. MSCs will be isolated and expanded. After approximately 2-3 weeks, patients will return for an intra-articular injection of 50x106 MSCs Subsequent study visits will occur on post-injection day 7 and months 2, 6, 12, and 24. Safety of intra-articular injection of MSCs will be evaluated at study visits by interval history, physical examination and assessment of any adverse events that are observed/reported. Additionally, efficacy will be evaluated by having patients complete functional outcome measures including: Visual Analog Score (VAS) for pain, Knee Injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC) Subjective Knee Form, and Lysholm Knee Scale. These will be completed at the pre-treatment visit and then repeated at the 2, 6, 12, and 24-month follow-up visits. Lastly, T1 rho and T2 mapping on magnetic resonance imaging (MRI) will be used to assess for improved cartilage quality after intra-articular injection of MSCs. An MRI will be obtained at the pre-treatment visit. At the 12 and 24 month follow up visit, additional MRIs will be obtained and analyzed to compare the pre-treatment MRI to post-treatment MRIs.

A Randomized Study Comparing of Three Doses Nebulized Fentanyl in Older Adults

This clinical trial compares three different nebulized fentanyl dosages for older persons experiencing severe musculoskeletal pain at the emergency department. The main objective is: Does the effectiveness of nebulized fentanyl at dosages of 2 mcg/kg, 3 mcg/kg, and 4 mcg/kg at 30 minutes differ in older patients who report to the emergency room with pain from musculoskeletal injuries? Secondary outcome are: 1. Incidence of adverse effects after drug administration at minutes 0, 15, 30, 45, 60, 75, 90, 105, 120 2. Incidence of receiving other pain relief treatments (rescue therapy) in minutes 30, 45, 60, 75, 90, 105, 120 Participants will receive an explanation of the study and possible side effects, which may take approximately 5-10 minutes, without affecting the primary treatment of the patients. Consent will be obtained in this study, along with signing or fingerprinting as evidence in the consent form.

Central Sensitization, Work-Related Stress, and Musculoskeletal Symptoms in Desk-Based Workers With and Without Migraine

Migraine is a common neurological disease causing significant disability worldwide, with an estimated global prevalence of 14.4%. It represents a significant individual and societal burden, particularly for working-age individuals, as it can significantly impact work performance, productivity, and daily living activities. Migraine is not merely a headache; it is characterized by increased excitability of neurons in the central nervous system, leading to hypersensitivity to pain. Central sensory mechanisms are thought to play a role in the pathophysiology and chronicity of migraine, causing increased pain sensitivity, allodynia, and potentially related to musculoskeletal pain. Furthermore, psychosocial factors and work stress have been identified as significant factors associated with both headaches and musculoskeletal pain. Literature indicates that neck pain is common in individuals with migraine headaches; in fact, neck pain is twice as frequent in patients with chronic migraine headaches compared to those with episodic migraine. While evidence regarding back pain is limited, it has been shown that individuals with chronic headaches report back pain more frequently. In modern work environments, sedentary work and prolonged computer use are increasing. Prolonged sitting, improper ergonomics, and repetitive movements are considered significant risk factors for musculoskeletal problems. This can lead to pain and functional limitations, particularly in the neck, shoulders, and back. Although there has been an increase in working from home, especially after the pandemic, the time spent at a desk is still similar to that spent in the workplace. It is stated that static muscle activity and improper postures maintained during prolonged computer use can lead to increased strain on cervical and upper extremity muscles, exacerbating musculoskeletal symptoms. Literature reports that headaches and neck pain are common among individuals who work at desks; for example, a study of office workers reported that approximately 80% of individuals with headaches also experienced neck pain. Furthermore, high workload, time pressure, and psychosocial stress factors have been shown to be associated with both headaches and musculoskeletal pain in individuals who work at desks. Therefore, desk-based work conditions are considered a significant environmental factor that may play a role in the onset or exacerbation of migraine and musculoskeletal symptoms. Despite this, studies examining musculoskeletal symptoms, central sensitivity, and work stress together in desk-bound migraine patients are limited in the literature. Most studies have only examined individuals with headaches or evaluated musculoskeletal findings in limited areas. Therefore, studies comparing desk-bound migraine patients with non-migraine-bound desk-bound individuals could fill a significant gap in the literature. In this context, it is believed that the planned study will contribute to a better understanding of the possible relationships between migraine and musculoskeletal symptoms, help develop protective and rehabilitative approaches to the work environment, and benefit individuals exposed to musculoskeletal risks in desk-bound work, within the scope of Sustainable Development Goals 3: ensure healthy lives and promote well-being for all at all ages. The aim of this study is to compare central sensitization, work-related stress levels, and musculoskeletal symptoms in desk-based workers according to the presence of migraine and to examine the relationships among these variables.

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.

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 Impact of Insomnia on Pain Sensitivity and the Trajectory of Exercise-induced Muscular Pain

Sleep is a critical determinant of physiological recovery and pain regulation. Growing evidence suggests that sleep disruption directly heightens central and peripheral pain sensitivity to sensory stimuli (e.g., mechanical pressure, thermal stimuli), serving as a significant risk factor for the onset and persistence of musculoskeletal pain. However, the precise mechanisms through which sleep quality regulates bodily sensory sensitivity and influences the onset, progression, and recovery trajectories of acute musculoskeletal pain in the general public remain insufficiently understood. This study aims to investigate the relationship between sleep condition, pain sensitivity, and musculoskeletal pain dynamics in healthy adults from the general population, regardless of their physical activity levels. Utilizing a standardized, safe, and fully reversible exercise-induced muscle soreness (EIMS) protocol as an experimental pain model, this project will continuously evaluate participants' quantitative sensory testing (QST) profiles and sleep parameters. The findings from this study will advance the mechanistic understanding of sleep-mediated pain modulation, providing evidence-based insights to inform future targeted sleep management and pain prevention interventions.

The Impact of Acute Pain on Sleep Parameters in the Insomnia Population and Healthy Controls

This study investigates how acute exercise-induced muscular pain affects sleep quality and sleep architecture in people with insomnia compared to healthy sleepers. Sleep disturbances and pain often influence each other, creating a negative cycle; however, it remains unclear how acute muscle pain - such as delayed-onset muscle soreness (DOMS) after strenuous exercise - alters continuous sleep parameters and pain sensitivity differently in clinical insomnia populations versus healthy controls. Participants will be divided into two groups: individuals with clinical insomnia and age- and sex-matched healthy sleepers. Both groups will undergo a standardized exercise protocol designed to safely induce temporary, acute muscular soreness (DOMS). Objective sleep parameters (measured via wrist Actigraphy) and subjective sleep parameters (measured via sleep diaries), will be monitored before and after the pain induction. The primary goal is to determine whether individuals with insomnia experience greater sleep disruption and altered pain recovery trajectories following an acute painful event compared to healthy individuals.

Physical Activity in Lawyers: Factors Affecting Musculoskeletal Pain

This study aims to determine the prevalence and distribution of musculoskeletal pain among lawyers registered with the Isparta Bar Association, specifically in relation to their varying levels of physical activity. The data obtained will help establish the relationships between physical activity levels, occupational factors, stress, and job satisfaction, thereby providing a foundation for developing personalized and preventive physiotherapy approaches for this specific population. Furthermore, the study will serve as a guiding resource for the ergonomic improvement of lawyers' working conditions and the formulation of occupational health policies. H1: There is a statistically significant relationship between lawyers' physical activity levels and the frequency, distribution, and severity of musculoskeletal pain in various anatomical regions of the body. H2: Physical activity level, perceived stress, occupational burnout, and job satisfaction levels are significant predictors of musculoskeletal pain among lawyers. H3: There is a statistically significant difference between lawyers' sociodemographic and professional characteristics (duration of employment, daily time spent at a desk and using a computer, etc.) and their perceived stress and job satisfaction scores. H4: Musculoskeletal complaints and functional limitations are significantly higher among lawyers experiencing high levels of perceived stress and occupational burnout compared to the group reporting low stress and burnout.

The Effect of Different rTMS Interventions on Acute Experimental Muscular Pain in Individuals Comorbid With Insomnia

Insomnia exacerbates pain sensitivity and impairs physiological recovery from acute musculoskeletal pain. Repetitive transcranial magnetic stimulation (rTMS) has emerged as a promising non-invasive neuromodulation intervention to alleviate pain and modulate central sensory processing. However, whether rTMS can effectively mitigate insomnia-induced pain hyperalgesia and accelerate the recovery trajectory of acute musculoskeletal pain remains unclear, as does the optimal neuroanatomical stimulation target. Building upon an established experimental pain model, this randomized, sham-controlled study aims to evaluate the restorative effects of three distinct rTMS interventions - targeting the left primary motor cortex (L M1), the right dorsolateral prefrontal cortex (R DLPFC), and a sham condition - on individuals experiencing insomnia. Following a standardized eccentric exercise protocol to induce muscle soreness, participants will receive three sessions of the allocated rTMS intervention at 0, 24, and 48 hours post-exercise. Pain sensitivity, recovery dynamics, and quantitative sensory testing (QST) metrics will be continuously monitored across the recovery timeframe. The findings from this trial will clarify the therapeutic efficacy of rTMS in modulating acute pain under insomnia states and identify the target-specific mechanisms of cortical stimulation, offering evidence-based non-invasive interventions for musculoskeletal pain management.

Integrated Healthy Lifestyle and Pain Care for People With Musculoskeletal Conditions Living in Rural Areas.

This study aims to compare the effects of an in-person physiotherapist-led lifestyle-focused pain care intervention with a virtual multidisciplinary lifestyle-focused pain care intervention on pain impact in people with musculoskeletal conditions and lifestyle risks. Adults residing in rural and regional locations in New South Wales (AUS) with musculoskeletal conditions (low back, knee or hip pain) recruited from hospital outpatient services (physiotherapy, emergency or orthopaedics) or in response to social media advertisements. Eligible consenting participants will be randomised in a 1:1 ratio to receive either in-person physiotherapy lifestyle intervention or the virtual enabled multidisciplinary intervention. Randomisation will be conducted using an electronic central randomisation service to ensure concealment of treatment allocation. Participants in both arms (in-person and virtual care) will have up to 10 consultations over six months and follow similar principles based on the previous Healthy Lifestyle for Pain (HeLP) intervention, but differ in their mode of delivery and access to multidisciplinary care. Participant data will be collected at baseline and weeks 12, 26, 39 and 52. The primary outcome will be Pain Impact measured using the Patient-Reported Outcomes Measurement Information System (PROMIS-29). The secondary outcomes will include participant's health behaviors and mediating outcomes, economic outcomes, process outcomes and adverse events.

Comparing Reports Recorded by the Patients at the Time at Which They Feels Pain to What Patients Report at Monthly Visits to Assess Symptoms of Musculoskeletal Diseases.

Patients will be introduced to the use of a mobile application for their smartphone to record the Ecological Momentary Assessment (EMA). This app will ask the patients to assess their pain and function two times daily for 2 months. After 1 month and at the end of the 2 months, follow-up visits will be performed and patients will be asked to retrospectively evaluate the pain that they suffered and the level of function they had during the last month.

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.

Active Coping: Interdisciplinary Program for Chronic Pain, Physiotherapy Unit (Spain)

The goal of this observational intervention study is to evaluate the impact of a multidisciplinary active coping program for chronic back pain in adults referred from Primary Care to the Physiotherapy Unit of Teruel Ensanche. The main questions it aims to answer are: * Does the program improve physical function, measured through gait speed, balance, and chair stand tests? * Does it reduce pain-related psychological factors such as kinesiophobia, catastrophizing, anxiety, and depression? * Does it improve quality of life and sleep quality, and reduce analgesic medication use? Participants will attend group sessions on pain neuroscience education, followed by sessions on healthy habits, nutrition and sleep hygiene and group psychological intervention focused on emotional wellbeing tools, and will complete therapeutic exercise sessions over the course of the program. They will also complete validated questionnaires and physical assessments at three timepoints: at baseline, at the end of the program, and at a 6-month follow-up.

Piloting a Novel Peer Support Pain Self-Management Intervention (Project CONNECT)

The proposed study will test the feasibility and acceptability of an 8-week home-based reciprocal peer support pain self-management intervention (CONNECT) for women Veterans with chronic musculoskeletal pain. The use of this format will improve the accessibility of treatment to women Veterans who experience logistical, healthcare delivery and psychosocial barriers to care. To address these barriers women Veterans who enroll in CONNECT will be paired and work together to learn/practice pain coping skills, set meaningful activity goals, and participate in a graduated walking program; they will exchange nightly text messages and engage in a weekly 20 minute phone call to reinforce each other and provide support for pain self-management efforts. This is a single-arm pilot project; all eligible and interested women with chronic musculoskeletal pain will receive CONNECT. The primary outcome will be post-treatment and long-term follow-up retention rates.

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.

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.

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.

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.