Clinical Research Directory

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.

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.

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).

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.

Equipping Patients Using Interventions for Pain and Depression

This project is part of the NIH Helping to End Addiction Long-term (HEAL) initiative (https://heal.nih.gov/). This randomized controlled trial (RCT) is phase 2 of a two-phase, 5-year project with the overarching goal of testing a decision aid (DA)/coaching intervention, tailored to Black patients with comorbid chronic pain and depression, to encourage use of and adherence to nonpharmacological pain treatments (NPTs). This 2-arm trial will randomize 304 patients with comorbid chronic musculoskeletal pain and depression in primary care from an urban safety-net health system (Eskenazi). After the baseline assessment, patients randomized to the intervention will be asked to participate in 4 coaching sessions over approximately 12 weeks. Sessions will use Motivational Interviewing principles to foster openness to NPTs and self-efficacy by helping patients identify their goals and priorities, understand their NPT options, prepare them to discuss and choose options with their primary care providers (PCPs), and reinforce these choices to foster maintenance of these changes. DA contents will be integrated into these sessions, which will facilitate discussion of these options with their PCP. The first 3 sessions take place prior to the patient's next scheduled PCP visit; the final session occurs after this visit. Assessments will be conducted at baseline, 3 months (i.e., after completing the final coaching session), and 6 months. Patients randomized to the wait-list control group will receive usual care (in addition to study assessments at baseline, 3 months, and 6 months). After completing the final assessment, they will then be given the DA and offered a 20-minute coaching session to walk them through it.

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.

Posture Training for Middle Schoolers

The goal of this clinical trial is to investigate if posture training can improve back pain and posture in middle school students. The main questions it aims to answer are: * Can posture training reduce back pain in middle school students? * Can posture training improve body posture in middle school students? Researchers will compare training and control groups to see if posture training reduces pain and improves body posture. Participants will; * Fill a survey assessing pain and body posture at three time points: before the training, immediately after, and at the 1st and 3rd months * Attend three sessions of training on correct body posture and spinal health and its importance, and exercises to be done for spinal health

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.

Supraspinal Processing of Sensory Aspects of Pain

The goal of this basic science study is to learn about the brain mechanisms of chronic pain across different chronic pain syndromes in pediatric patients. The main questions it aims to answer are: * Are there shared and distinct brain systems engaged by different forms of pediatric chronic pain? * What are predictors of recovery from chronic pain? * What brain systems are associated with the spread of pain? For this study participants will undergo: * Functional Magnetic Resonance Imaging (fMRI) * Quantitative Sensory Testing * Psychological Assessments

Translation and Validation of the Limbs, Pain, Autonomy, Depression, Anxiety and Quality of Life Scales in Albanian

The cross-cultural adaptation will be performed according to the internationally recommended methodology, using the following guidelines: translation, back-translation; revision by a committee, questionnaire diffusion and data collection and analyzing. The psychometric properties will be evaluated by administering the questionnaire to approximately 300 participants. Reliability will be estimated through stability and homogeneity assessment

The PROACTIVE Study for Black Elders

Chronic musculoskeletal pain (CMP), while a leading cause of physical disablement, is a neglected national health disparity issue in Black communities. The purpose of this study is to test a novel culturally congruent pain self-management intervention. A total of 120 persons aged 50-92, self-identifying as Black or African American having CMP will be invited to participate in this study. The primary outcome measured throughout this 3-year study is movement-evoked pain (MEP).

The PROmoting Pain Self-Management (PROs) Trial: Holistic Pain Care in the Military Health System

The goal of this study is to improve pain care in the MHS by identifying effective, whole-person, non-pharmacologic interventions for persons with chronic musculoskeletal pain. The investigators will evaluate two promising, evidence-based holistic health interventions and compare them to usual care.

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of resO™ Bone and Joint Support Postbiotic on Physical Function, Pain Interference, and Mobility in Adults With Joint Discomfort

This randomized, double-blind, placebo-controlled study evaluates the effects of resO™ Bone and Joint Support Postbiotic on physical function, pain interference, mobility, and recovery in adults aged 18-75 years experiencing joint discomfort, stiffness, or reduced mobility. Participants will be randomized to receive either resO™ or placebo for 4 weeks. Outcomes will be assessed using validated patient-reported outcome measures, including PROMIS Physical Function, PROMIS Pain Interference, Duke Activity Status Index (DASI), International Physical Activity Questionnaire-Short Form (IPAQ-SF), and pain numeric rating scales. The primary objective is to evaluate whether resO™ improves physical function and reduces pain interference compared with placebo.

AI-Assisted Camera-Based Progressive Muscle Relaxation for Office Workers

This randomized controlled trial evaluates the effectiveness of an AI-assisted, camera-based progressive muscle relaxation application in office workers aged 20 to 40 years. Participants are randomly allocated to an intervention group or a control group. The intervention group completes a 4-week progressive muscle relaxation program using the PhysioTR Academic application, which provides camera-based real-time movement analysis and exercise guidance. The control group continues their usual daily routine and completes baseline and post-intervention assessments only. Outcomes include pain/tension intensity, musculoskeletal symptoms, perceived stress, neck disability, work productivity, functionality, and AI-based adherence metrics.

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.

Neural Mechanisms of Light Driven Analgesia

The goal of this study will be to understand the biological mechanisms that are responsible to light-driven analgesia. Light presented to the retina has been shown to have pain relieving properties in pre-clinical and clinical studies. In this study the investigators will evaluate the functional connectivity between subcortical visual areas and non-image forming brain areas that are involved in pain sensation. The investigators will also evaluate how three colored light stimuli presented to the retina results in changes in whole brain evoked activation patterns in participants with chronic musculoskeletal pain and in healthy controls. The investigators will also assess while brain evoked activation patterns in response to a pressure pain stimulus in the presence of three light stimuli in individuals with chronic musculoskeletal pain and healthy controls.

Emergency Department Acupuncture for Acute Musculoskeletal Pain Management

The purpose of this project is to determine the feasibility, acceptability and effectiveness of acupuncture in the Emergency Department (ED) for treating acute musculoskeletal pain. The overall goal is to reduce acute and subacute opioid use by improving acute pain, anxiety and disability with non-pharmacologic treatment options at a critical entry point for patients into the healthcare system. This full-scale randomized controlled trial (RCT) has been statistically powered to test the effectiveness of ED-based acupuncture for both one-hour (Stage 1) and one-month (Stage 2) pain reduction outcomes. The feasibility will be assessed based on patient recruitment and retention rates, while the acceptability will be assessed using patient reported outcomes and qualitative semi-structured interviews. Stage 1 is a 2-phase study design. Phase (1): Enrolled subjects will be randomized to auricular (ear) acupuncture, peripheral acupuncture, or the control group receiving no acupuncture. Subjects assigned to an acupuncture arm will receive information and access to acupuncture in an outpatient clinic for the 4 weeks following ED visit. Subjects may also have a blood draw for biomarker analysis during their ED visit. A planned interim analysis of the first 60 patients (2/3 of the Phase 1 arm completed) will be completed to select the more effective and/or acceptable arm for Phase 2. At interim analysis, it was determined by the DSMB that neither arm was superior, so the recommendation was to continue Stage 1 Phase 2 unchanged with 3 arms. Stage 1 is complete, and we will proceed with Stage 2 powered to the 4-week pain score outcome. Stage 2 will proceed with the same procedures as stage 1, only powered to a different outcome.

Life-Style Medicine for Chronic Musculoskeletal Pain in Older People

The goal of this clinical trial is to determine the clinical effectiveness of lifestyle medicine in reducing chronic musculoskeletal pain in older adults, as measured by pain intensity, pain interference, self-management efficacy, stress level, sleep quality, healthier diet, better quality of life, and cost-effectiveness, compared to a waitlist control group. Participants will be randomly assigned to either the intervention or the waitlist group. The intervention group will meet the health coach face-to-face for four sessions to negotiate and set personalized health goals. The waitlist control group will continue to receive usual care without any additional intervention for 24 weeks. Both groups will complete three assessments: at the start of the study, one month after the intervention, and three months after the intervention. The waitlist control group will be offered the same intervention after completing the study.