Clinical Research Directory

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.

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.

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.

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.

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.

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.

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.

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.

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.

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, we 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. We 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). We will examine RYD feasibility and acceptability as well as changes over time in outcomes (pain interference, depression, quality of life) and putative mediators.

Online Yoga vs Acceptance and Commitment Therapy for Treating Chronic Musculoskeletal Pain

This study will compare online yoga with Acceptance and Commitment Therapy (ACT), an established treatment for chronic pain. We will compare the efficacy of the two treatments for reducing chronic musculoskeletal pain in veterans.

Examining the Impact of a Digital Health Program and TENS Device for Patients With Chronic Low Back Pain

The goal of this study is to examine the extent to which Hinge Health, a digital musculoskeletal program, and Enso, a wearable pain relief device, have clinically significant impact on the pain, function, and health care use among patients undergoing non-imperative care for chronic lower back pain.

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.

Insomnia in Patients Participating in Interdisciplinary Pain Rehabilitation

The main purpose of this project is to conduct a prospective cohort study in order to better understand the importance of insomnia symptoms in patients referred to interdisciplinary rehabilitation due to chronic pain. Moreover, this project will also raise awareness on how insomnia symptoms, alone, and in interplay with factors such as function, psychological distress, physical activity, and fatigue impact on patient's prognosis and work ability. Our aim is that this knowledge can be used to design new interventions and improve rehabilitation programs for this patient group.

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.

Kinesiophobia and Physical Function in Elderly With Musculoskeletal Pain

This study aims to investigate how kinesiophobia (fear of movement), pain intensity, and physical performance are related in older adults experiencing musculoskeletal pain. Musculoskeletal pain is highly common in the elderly due to age-related degenerative changes, such as osteoarthritis, chronic low back pain, osteoporosis, and muscle weakness. These conditions often lead to reduced mobility, impaired balance, and limitations in daily living activities. As a result, many older adults may avoid physical activity due to fear of pain or reinjury, which may further decrease their functional capacity. The primary purpose of this study is to understand whether kinesiophobia contributes to lower physical performance in elderly individuals who have musculoskeletal pain. The study will also examine how pain intensity relates to balance, upper and lower limb strength, and overall functional ability. Participants aged 65 years and older will complete a set of standard assessments in a single 30-minute session. Kinesiophobia will be measured using the Tampa Scale of Kinesiophobia, a 17-item questionnaire designed to assess fear of movement and avoidance behaviors. Balance will be evaluated with the Berg Balance Scale, which includes 14 tasks commonly performed in daily life. Lower limb strength will be assessed with the 30-Second Sit-to-Stand Test, while upper limb strength will be measured with a handgrip dynamometer. Understanding these relationships may help clinicians design better rehabilitation programs that reduce fear, improve physical performance, and support healthy aging. The findings of this study may also contribute to strategies for preventing disability and promoting independence in older adults with musculoskeletal pain.

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.

PEACE: Comparing Chronic Pain Treatment Options

The purpose of this study is to compare two types of acupuncture with usual care on treating chronic pain. This study has three groups. Two groups will received acupuncture. One group will receive usual standard of care for 12 weeks and then will receive acupuncture. Acupuncture is an ancient Chinese technique of using very thin needles inserted in the skin to treat different symptoms and illness, and to promote healing. Each group will undergo a different method of needle administration.

Group Medical Visits and Chiropractic Care for Older Adults With Chronic Spine Pain

Chronic spine pain is one of the most common and conditions in adults over the age of 65. Treatments for pain that are non-pharmacologic (do not use over-the-counter or prescription drugs) are recognized as some of the most important to study. Chiropractic care has shown to be effective at reducing chronic pain, and growing research supports the use of group visit programs for the management of chronic pain. There is reason to believe that combining the two could enhance the benefit previously demonstrated by these treatments individually. There are no studies that have examined the combined delivery of chiropractic care and group visit programs for adults over the age of 65. The investigators plan assess the feasibility of treating adults over the age of 65 with chronic spine pain with chiropractic care and a group visit program. A battery of biopsychosocial outcomes will be collected to inform a more definitive trial.

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