Clinical Research Directory

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.

Noninvasive Neuromodulation in the Management of Post-COVID Musculoskeletal Pain

Brief Summary: The post-Covid syndrome is a problem that affects a significant number of people in the world. Among the most common symptoms is pain, and although there is no specific data on neuropathic pain and Covid, due to under-diagnosis, they may be closely related. Non-invasive neuromodulation acts on the Central Nervous System through the bioelectrical stimulation of nervous tissue and modulation of the system nervous, and can be useful in acute, chronic and musculosqueletal pain, and in symptoms such as stress, anxiety and sleep disturbances. The objective of this clinical trial is to assess the efficacy of non-invasive neuromodulation in the treatment of post-Covid musculoskeletal pain. Subjects will be randomly divided into two groups: an experimental group in which non-invasive neuromodulation will be applied and a sham group to which it will be applied off. The variables to be studied before, during and after treatment will be neuropathic pain with the DN4 questionnaire, pain intensity with the EVA scale, sleep quality with the Pittsburgh Sleep Quality Index, level of stress and anxiety with the HADS questionnaire and quality of life with the SF12.

Effectiveness of the Healthy Workplace Participatory Program With Peer-led Teams in Public Sector Healthcare Facilities

Safety \& Health through Integrated, Facilitated Teams (SHIFT) is an intervention study to enhance employee health, safety, and well-being in public sector healthcare institutions in New England. The investigators will evaluate the effectiveness of an adapted form of the Center for the Promotion of Health in the New England Workplace (CPH-NEW) Healthy Workplace Participatory Program (HWPP) for strengthening cohesiveness, engagement, and impact of pre-existing joint labor-management health and safety committees. The sites are enrolled in three pairs, matched by agency and type of services. For each pair of sites, one will be randomly selected for immediate HWPP coaching. The paired organization will serve as a control until the study mid-point, at which time all sites will be coached. Process evaluations will examine barriers to and facilitators of program uptake, reach, and effectiveness. Survey data and injury records will be examined in intervention and control groups to describe the frequencies of workplace and non-occupational exposures of selected health outcomes.

Mindfulness-based Rehabilitation in a University Museum Setting to Reduce Pain and Improve Quality of Life in Women With Fibromyalgia: a Randomized Controlled Trial

This research study aims to investigate whether art and integrative medicine, within a unique setting like a university museum, can offer a new approach to help women suffering from fibromyalgia. Fibromyalgia is a chronic condition causing widespread pain and other symptoms such as fatigue and sleep disturbances. The question this study seeks to answer is: Is an 8-week rehabilitation program, based on mindfulness and body awareness techniques, conducted at the University Museum of the G. d'Annunzio University, effective in reducing pain and improving the quality of life (physical and mental well-being) and coping abilities in female fibromyalgia patients? Participants will be randomly assigned to either receive this program in the museum or to a control group.

A Clinical Study to Assess the Safety and Effectiveness of Dharasana Lep in Patients With Mild to Moderate Muscular, Joint, or Rheumatic Pain

A Prospective, Open-Label, Single-Centre Interventional Study to Evaluate the Efficacy and Safety of Dharasana Lep in Patients with Mild to Moderate Musculoskeletal Pain and Rheumatoid Arthritis.

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.

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.

Analgesic Effect of a Biophotonic Foot Massage Cream

This study aims to evaluate the effectiveness of a biophotonic cosmetic massage cream in reducing musculoskeletal foot pain in adults. Participants with pain in one or both feet attending the Podiatry Clinical Area of the University of Seville will be randomly assigned to receive either the investigational cream or a placebo cream with similar characteristics. The assigned product will be applied topically to the painful area twice daily for 10 consecutive days. Pain intensity, pressure pain threshold, foot function, and health-related quality of life will be assessed during the study.

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.

Personalizing Veteran Pain Care: Adapting Coaching Interventions to Support Maintenance of Self-Care

Half of all Veterans who seek care from the Veterans Health Administration (VHA) experience chronic musculoskeletal pain. First-line treatment for chronic pain should include nonpharmacological interventions. Although Veterans have access to these interventions, there is no standardized process to personalize them to meet the needs of individual Veterans despite the fact that personalization and self-care are key components of the VHA's Stepped Care Model for pain management. This proposal seeks to adapt and evaluate a coaching intervention that will be a personalized approach to help Veterans develop and maintain pain self-care plans. The proposed research responds to VHA's strategic objectives to tailor service delivery (obj. 2.2) and develop or adapt interventions that improve Veteran outcomes (obj. 2.4).

Personalized Care Management Model (GAP-421) for Chronic Pain in Primary Care Physiotherapy

This multicenter pilot study evaluates the feasibility, implementation fidelity, and preliminary effects of the GAP-421 (Personalized Care Management) model for chronic pain management in primary care physiotherapy. The GAP model is a time-limited organizational modality that reconfigures schedules, resources, and professional roles during a defined 6-week window to organize care around the individual patient and their trajectory, formalizing coordination work that previously occurred informally. The study uses a convergent mixed-methods design across three primary care health centers in the Southeast Healthcare District (DASE) of the Community of Madrid, Spain. The quantitative component is a prospective multicenter pre-post case series with 3-month follow-up (n=66 patients, 22 per center). The qualitative component includes semi-structured interviews (n=12) and focus groups (3 groups, n=6 each). Integration occurs through Joint Display, Pillar Integration Process, and a 9-type legitimation framework. The primary outcome is patient-perceived care coordination measured on a 0-10 numerical scale (PREM). Secondary outcomes span five domains: patient-reported outcomes (EQ-5D-5L, Graded Chronic Pain Scale, pain intensity), professional outcomes (coordination burden, role clarity), system sustainability (avoidable re-consultations, emergency department use), implementation fidelity, and feasibility indicators. Results will generate feasibility parameters, intraclass correlation coefficient estimates, and process indicators essential for designing definitive cluster-randomized trials testing organizational interventions in primary care physiotherapy.

The Prevalence of Neck and Low Back Pain in FMSTRC Staff At the UWI Mona

The purpose of this study is to determine the prevalence of neck and low back pain among full-time staff at the Faculty of Medical Sciences Teaching and Research Complex (FMSTRC), The University of the West Indies, Mona. It also seeks to assess staff members' knowledge, attitudes, and practices regarding spine health and to evaluate the effectiveness of an eight-week standardised spine-specific exercise programme in reducing musculoskeletal discomfort among those experiencing neck and low back pain. The study will be conducted in two phases using a descriptive cross-sectional design followed by a prospective randomised controlled trial, in which participants reporting pain will be allocated to either a spine-specific exercise intervention group or a non-spine-specific exercise control group for comparative analysis of outcomes.

Phase 1 Pilot of 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. This new project will happen in two parts, but we will only focus on the first part in this entry: In the first part (a 1-year phase), 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.

Neck and Low Back Pain in Physical Therapy Students at The University of the West Indies, Mona, Jamaica

The purpose of this study is to determine the prevalence of neck and low back pain among physical therapy students enrolled at The University of the West Indies, Mona. It also aims to assess students' knowledge, attitudes, and practices regarding spine health and to evaluate the effectiveness of an eight-week standardised spine-specific exercise programme in reducing musculoskeletal pain and improving functional status among those reporting symptoms. The study will be conducted in two phases, beginning with a descriptive cross-sectional assessment of prevalence, followed by a prospective randomised controlled trial in which students experiencing neck and/or low back pain will be allocated to either a spine-specific exercise intervention group or a non-spine-specific exercise control group for comparative analysis of outcomes.

Low Back and Neck Pain in Nursing Students at The University of The West Indies

The purpose of this study is to identify the prevalence of neck and low back pain in nursing students enrolled at the University of the West Indies, Mona; to assess their knowledge, attitude and practice of good spine health and to determine the outcome of a standardised spine exercise program on nursing students experiencing neck and low back pain, using a prospective randomised control design.

Association of High PainDETECT Scores With Pain Region and Diagnosis in Patients Attending a Musculoskeletal and Sports Medicine Clinic

This observational study aims to evaluate the relationship between PainDETECT questionnaire scores, pain regions, and clinical diagnoses in patients presenting to a musculoskeletal and sports medicine clinic. Patients attending the clinic will complete the PainDETECT questionnaire, and their pain localization and clinical diagnoses will be recorded. The findings are expected to contribute to a better understanding of neuropathic pain components in musculoskeletal conditions.

Musculoskeletal Outcomes Using Tylenol/Ibuprofen vs. Oral Steroids in New Injuries

In this pilot study, the investigators aim to compare two short-term pain relief methods administered over the course of 6 days in the setting of acute musculoskeletal (MSK) pain: 1. Methylprednisolone((Medrol)dose pack- standard taper per dose pack instructions 2. Standard of Care (SOC) which includes a combination of Acetaminophen (Tylenol)+Ibuprofen (Motrin) The investigators are interested in studying pain relief regimens for acute injury of any body part among an adult orthopaedic urgent care population.

Multicomponent Care for Aromatase Inhibitor-Related Musculoskeletal Symptoms

Breast cancer patients who receive endocrine therapy particularly aromatase inhibitors often experience aromatase inhibitors associated symptoms (AIMSS) such as joint and muscle pain along with stiffness and fatigue that can disrupt with daily activities and lead some patients to stop treatment early. A structured intervention program named AIMSS-CARE (Aromatase Inhibitor-associated Musculoskeletal Symptoms-Comprehensive Adapted Rehabilitation Evaluation) developed in China that combines exercise, education, symptom monitoring, and follow-up has been shown to reduce these symptoms and improve treatment adherence. This study will adapt this program for use in Ethiopia while testing its effectiveness to enhance pain management, treatment adherence and quality of life among Ethiopian breast cancer patients receiving endocrine therapy. The study will be conducted at Tikur Anbessa Specialized Hospital in Addis Ababa, Ethiopia. Eighty-eight patients will be randomly assigned to either the adapted intervention program or usual care. The research will also examine the feasibility and acceptability of the intervention to patients and healthcare providers, and what factors influence its successful implementation. Results will help determine whether this program can be used more widely in Ethiopia and other African cancer centers.