Clinical Research Directory

Group-Based Psychological Treatments Over Video Conference for Older Veterans With Chronic Pain

This study is being performed to compare the effects of three types of group-based psychological treatments delivered over video telehealth for chronic musculoskeletal pain in older U.S. military Veterans. The three types of psychological treatments are: Cognitive-Behavioral Therapy (CBT), Emotional Awareness and Expression Therapy (EAET), and Mindfulness Meditation (MM). In addition, the investigators will evaluate which patients respond best to each treatment and how each treatment works. The investigators are performing the study because chronic pain is a big problem among Veterans. Older Veterans are the focus because they have the highest rates of chronic pain, perhaps as high has 80%. The investigators are looking at psychological treatments because they are less risky than medications or procedures for older Veterans. Telehealth is an important aspect of the proposal, as delivery over telehealth could improve access to treatments. CBT is endorsed nationally by VA, but no standardized MM is available through VA, and only a few VA sites use EAET, which is a newer treatment focusing on how stress and emotions affect pain. The project aims to evaluate a standardized form of MM and the newer treatment, EAET, compared to the standard CBT used widely in VA.

Pain Science Education and Therapeutic Exercise in Adults With Musculoskeletal Pain

This randomized controlled pilot trial evaluated the effectiveness of adding pain neuroscience education (PNE) to a therapeutic exercise program in adults with chronic musculoskeletal pain. Participants were randomly allocated in a 1:1 ratio to an experimental group receiving therapeutic exercise plus PNE or to a control group receiving therapeutic exercise alone. The intervention lasted 8 weeks. The primary objective was to evaluate the effect of the intervention on pain intensity. Secondary objectives included evaluating its effects on kinesiophobia, fear-avoidance beliefs, and muscle strength, as well as assessing the feasibility of the study protocol to inform the design of a future larger-scale randomized controlled trial.

Pain Disengagement Training (Open Pilot)

The investigators aim to conduct an open pilot trial to determine the initial feasibility of a self-directed writing-based intervention in individuals with chronic musculoskeletal pain and elevated pain catastrophizing. The investigators will assess the feasibility of recruitment, acceptability of the treatment, credibility and participant satisfaction, treatment adherence, and feasibility of assessments following pre-specified benchmarks.

Feasibility, Acceptability And Usability Of The InControl Web Platform - A Rando Mized Parallel-Group Pilot Study of Mixed-methods

This is a randomized, parallel-group pilot study that employs mixed methods (qualitative and quantitative approaches). The purpose of this study is to assess the feasibility, usability, and acceptability of an intervention with a digital component on the InControl web platform. The intervention is based on education in pain science and exercise, with the goal of managing chronic musculoskeletal pain in older adults. The intervention will be delivered through a combination of digital and in-person components and it will be compared to the usual intervention. It will also inform the design of a randomized controlled trial to evaluate the cost-effectiveness of InControl.

Network Modeling in Knee Osteoarthritis

This project seeks to understand inter-individual differences in chronic musculoskeletal pain (cMSKP). Our long-term objective is to develop clinically-feasible decision tools that enable whole-person assessment and management of cMSKP and guide personalized primary, secondary and tertiary prevention strategies. Our secondary objective is to understand how inter-relationships between physiological, biomechanical and psychosocial factors change over time and impact the experience of living with chronic pain.

Real-world Evidence of Cannabinoid for Observed Pain Relief

Chronic muscle pain is one of the most prevalent clinical challenges in sports medicine, significantly affecting training capacity, competitive performance, and quality of life in athletes. The endocannabinoid system has emerged as a promising therapeutic target for pain modulation in the sports context. This prospective, comparative, non-randomized observational study aims to evaluate whether adjuvant topical application of a cannabinoid balm (CBD:THC 3:1 - Papa \& Barkley) provides additional reduction in chronic muscle pain intensity in athletes, compared to systemic CBD oil alone, over 90 days of follow-up in a real-world clinical practice setting. Sixty adult athletes (amateur or professional) with established chronic muscle pain (≥3 months) who receive clinical indication for cannabinoid therapy will be followed in two observational cohorts: Cohort A (n=30), receiving only systemic CBD oil (60 mg/day oral/sublingual), and Cohort B, (n=30) receiving systemic CBD oil plus the topical cannabinoid balm (CBD:THC 3:1, applied twice daily to the affected muscle area). Treatment allocation is based exclusively on the clinical decision of the principal investigator, reflecting routine medical practice. The primary outcome is the change in Brief Pain Inventory (BPI) scores from baseline (D0) to end of follow-up (D90). Secondary outcomes include pain intensity (NRS), sleep quality (PSQI), quality of life (SF-36), perceived muscle recovery (TQR scale), functional capacity (LEFS/UEFI), rescue analgesic use, and safety/tolerability of the topical formulation. The study aims to generate real-world evidence on the effectiveness and safety of adjuvant topical cannabinoid therapy in athletes with chronic muscle pain in the Brazilian clinical practice setting.

vEAET-H for Chronic Pain Patients Using Medical Cannabis in Israel - A Feasibility Study

The goal of this clinical trial is to evaluate whether a culturally adapted, virtual, group-based emotional therapy called Emotional Awareness and Expression Therapy is feasible and whether it can help reduce chronic pain and improve emotional well-being among Israeli adults who suffer from chronic musculoskeletal pain and are treated with medical cannabis. Participants will attend a weekly 1.5-hour virtual group therapy session for 8 weeks, except for the first session, which will be held in-person at the hospital's clinic. The participants will take part in group discussions and emotional processing exercises, complete questionnaires about pain levels, mood, sleep, and quality of life, and continue their usual medical treatment as prescribed by their doctors.

Illness Perception and Treatment Expectations in Lateral Elbow Pain

This cross-sectional, correlational study aims to determine the predictors of illness perception and treatment expectations in adults with chronic lateral elbow pain. Sociodemographic characteristics, clinical findings (pain intensity, pain duration, elbow-specific function) and psychosocial variables (pain self-efficacy, fear-avoidance beliefs, pain catastrophizing) will be examined as candidate predictors of two patient-centred constructs: illness perception, measured with the Brief Illness Perception Questionnaire, and treatment expectation, measured with the Treatment Expectation Questionnaire. Data will be analysed using hierarchical multiple linear regression in three predictor blocks. The study is reported according to the STROBE statement.

Krill Oil for Pain in Elders

Chronic musculoskeletal pain contributes to mobility disability among older adults. Nutritional interventions, like omega-3 fatty acids, may help manage pain and improve physical function. Supplementation with krill oil may offer advantages to fish oil due to better absorption and additional nutrients. This pilot study aims to assess the feasibility of a clinical trial to determine the impact of krill oil supplementation on pain and function in older adults, informing future research.

Culturally Adapted EAET-H for Chronic Pain Patients Using Medical Cannabis in Israel - A Pilot Study

The goal of this clinical trial is to evaluate whether a culturally adapted group-based emotional therapy named "Emotional Awareness and Expression Therapy" can help reduce chronic pain and improve emotional well-being in Israeli adults who suffer from chronic musculoskeletal pain and are treated with medical cannabis. Researchers will compare patients who receive the emotional therapy along with their usual care to patients who receive usual care only, to see if the therapy leads to better outcomes in pain, mental health, and daily functioning. Participants will attend a weekly 1.5-hour group therapy session for 8 weeks; Take part in group discussions and emotional processing exercises; Complete questionnaires about pain levels, mood, sleep, and quality of life; Continue their usual medical treatment as prescribed by their doctors.

Non-invasive Vagus Nerve Stimulation for Chronic Musculoskeletal Pain

Chronic musculoskeletal (MSK) pain affects an estimated 20-33% of the global population and is frequently associated with autonomic nervous system dysfunction, characterised by symptoms such as orthostatic intolerance, palpitations, gastrointestinal dysmotility, and fatigue. Conventional treatments often fail to address this autonomic component, limiting their effectiveness. This pilot study investigates whether non-invasive vagus nerve stimulation (nVNS) using the gammaCore Sapphire device can reduce autonomic symptom severity and improve pain in adults with chronic MSK pain and confirmed autonomic dysfunction. RESTORE-MSK is a randomised, single-blind, sham-controlled, crossover pilot study. Twelve participants with chronic MSK pain (lasting 12 weeks or longer) and autonomic dysfunction (COMPASS-31 score of 17 or more) will be recruited from musculoskeletal clinics at Chapel Allerton Hospital, Leeds. Participants will be randomly allocated to receive either active nVNS or sham stimulation first, followed by a 2-week washout period, then crossover to the alternative treatment. Each treatment period lasts 14 days, with participants self-administering the device twice daily (morning and evening). The primary outcome is change in autonomic symptom severity measured by the Composite Autonomic Symptom Score-31 (COMPASS-31). Secondary outcomes include physiological response to the NASA Lean Test, pain severity and interference (Brief Pain Inventory), anxiety and depression (Hospital Anxiety and Depression Scale), quality of life (EQ-5D-5L), intervention acceptability, and recruitment feasibility. This pilot study aims to establish feasibility and proof of concept for a larger randomised controlled trial investigating nVNS as a non-pharmacological treatment option for chronic MSK pain with autonomic dysfunction.

Effectiveness of Communication-Focused Pain Neuroscience Education in Chronic Musculoskeletal Pain

This randomized controlled trial aims to evaluate the effectiveness of the "Algo(S)Therapy" Pain Neuroscience Education (PNE) program in patients with chronic musculoskeletal pain. The study will assess whether the integration of communication skills training for physiotherapists enhances the outcomes of PNE. Participants will be randomly assigned to one of three groups: (1) PNE with communication-focused delivery, (2) PNE without communication emphasis, or (3) standard- usual physiotherapy care. The primary objective is to determine whether PNE combined with enhanced communication skills leads to greater improvements in pain, function, and psychosocial outcomes compared to the other interventions.

Assessing Pain, Patient Reported Outcomes and Complementary and Integrative Health

The APPROACH Study (Assessing Pain, Patient-Reported Outcomes and Complementary and Integrative Health) assesses the effects of use of practitioner-delivered CIH therapies alone compared to the combination of self-care and practitioner-delivered CIH therapies among Veterans with chronic musculoskeletal pain. The APPROACH study is predominately conducting a secondary analysis of patient-reported data being collected by the Veterans Health Administration's (VA) Office of Patient Centered Care and Cultural Transformation among Veterans receiving care at one of 18 VA medical centers. Those 18 facilities received funding to expand availability of CIH therapies as part of the Comprehensive Addiction and Recovery Act of 2016. That patient-reported data is being supplemented with VA electronic health record data and data on the 18 medical centers' business practices (nudges, the instrumental variable). Practitioner-delivered therapies under study include chiropractic care, acupuncture, and therapeutic massage; self-care therapies include Tai Chi/Qigong, yoga, and meditation. The primary outcomes are improvement in pain severity and pain interference, assessed using the Brief Pain Inventory (BPI), six months after initiating CIH therapies compared to baseline. Patients will enter treatment groups based on the CIH therapies they use, as randomizing patients to specific therapies would require withholding therapies routinely offered at VA. The investigators will address selection bias and confounding by using sites' variations in business practices and other encouragements (nudges) to receiving different CIH therapies as a surrogate for direct randomization using instrumental variables econometric methods.

Active Coping Program for Chronic Musculoskeletal Pain: A Controlled Clinical Study

Chronic musculoskeletal pain is a highly prevalent condition that is often associated with persistent pain, physical disability, and maladaptive psychosocial factors such as pain catastrophizing, fear of movement, and central sensitization. These factors can contribute to pain persistence and reduced quality of life, highlighting the need for multimodal, non-pharmacological interventions that address both physical and psychological dimensions of pain. The purpose of this study is to evaluate the effectiveness of an active coping program for patients with chronic musculoskeletal pain compared with usual care. The intervention is designed to promote active pain management strategies through education, movement-based exercises, and behavioral approaches aimed at improving pain coping, reducing disability, and addressing psychosocial contributors to chronic pain. This is a controlled interventional study in which adult patients with chronic musculoskeletal pain will be allocated to either an intervention group receiving the active coping program or a control group receiving usual care. Outcome measures will be assessed at baseline and after completion of the intervention. Primary and secondary outcomes include pain-related disability, pain catastrophizing, fear of movement, symptoms of central sensitization, and health-related quality of life, measured using validated questionnaires. The findings of this study are expected to provide evidence on the clinical effectiveness of an active coping approach in the management of chronic musculoskeletal pain and to support its implementation in routine clinical practice within primary care settings.

Correlation Between Diagnostic Nerve Block Response and Cryoneurolysis Outcome in Chronic Musculoskeletal Disorders

The clinical study is titled the CRYONIC PROTOCOL, which stands for Cryotherapy for Neurolysis In Chronic Pain. It is structured as a prospective, multi-cohort observational study. Purpose of the Study: The overarching purpose of the CRYONIC PROTOCOL study is to assess the Correlation Between Diagnostic Nerve Block Response and Cryoneurolysis Outcome in Chronic Musculoskeletal Disorders. The study focuses on evaluating the effectiveness of ultrasound-guided peripheral nerve cryoneurolysis, a minimally invasive technique that uses extreme cold to induce temporary nerve blocks, for patients with treatment-resistant chronic musculoskeletal pain. The study also seeks to determine if cryoneurolysis itself leads to meaningful improvements in both pain intensity and functional ability in the included patient cohorts.

Neural Mobilization to Improve Chronic Musculoskeletal Pain in Older Adults

The goal of this clinical trial is to discover whether performing active neural mobilization exercises works to manage chronic musculoskeletal pain in older adults. The main question it aims to answer is: Can an active neural mobilization program improve pain intensity and functional capacity? Participants will: * Perform active neural mobilization exercises for 8 weeks (twice a week), under the in-person supervision of a physiotherapist; * Visit the clinic twice a week for 9 to 12 weeks for consultations, examinations, and symptom monitoring; * Keep a diary of their symptoms and frequency of analgesic use.

PainTrain-AI Pilot: Feasibility, Usability (SUS) and Concept-Shift in Primary Care and a Specialized Setting

This pilot will assess feasibility and usability (SUS) and explore concept shift (reduction of neurophysiology misconceptions) after exposure to a behavioral educational intervention (PainTrain AI), a digital clinical simulation "fenced" by evidence (RAG) for safe, non diagnostic training. The study will be conducted in Primary Care and in a specialized comparative setting, without patient data collection. Primary endpoint: SUS score. Secondary endpoints: concept shift, adherence to micromodules, and interaction latency as friction metric. The platform does not generate clinical advice; it retrieves validated teaching content.

Multimodal Intervention for Persistent Musculoskeletal Pain in Primary Care

This multicenter randomized controlled trial aims to evaluate the effectiveness of a multimodal intervention for the active management of persistent musculoskeletal pain in primary care. The intervention combines pain neuroscience education, therapeutic exercise, and the promotion of self-care and healthy lifestyle habits to improve health-related quality of life in adults with persistent nonspecific musculoskeletal pain lasting at least six months. A total of 146 participants aged 18 to 70 years will be recruited from five primary care centers in the Comunitat Valenciana (Spain) and randomly assigned to either the experimental group or the control group. The primary outcome is health-related quality of life measured using the SF-36 Health Survey. Secondary outcomes include pain intensity, pain catastrophizing, kinesiophobia, central sensitization, emotional symptoms, perceived social support, medication use, and lifestyle-related variables. Assessments will be conducted at baseline, post-intervention, 6 months, and 12 months follow-up.

Diagnostic and Prognostic Biomarkers for High-impact Chronic Pain: Development and Validation

To identify diagnostic and prognostic biomarker signatures of recovery versus having persisting high-impact chronic pain and functional disability in adults with Chronic Musculoskeletal Pain.

The Effect of a Technology-Mediated Integrated Walking and Tai Chi Intervention on Physical Function in Veterans With COPD and Chronic Musculoskeletal Pain

Persons with COPD benefit from being physically active, but they are often limited by chronic musculoskeletal pain. This project will determine whether a non-pharmacologic, integrated, technology-mediated walking and Tai Chi mindfulness intervention can improve physical function in Veterans with COPD and chronic musculoskeletal pain. The proposed research addresses VA Rehabilitation R\&D Service's high priority area of improving health-related quality of life by reducing disease burden and maximizing function in Veterans with chronic disease.

Functional and Occupational Rehabilitation of Troops

The proposed implementation science project will evaluate the factors that support or hinder the successful implementation of the FORT Functional Restoration Program at six Military Treatment Facilities (MTF) across the Military Health System. It will also evaluate the associated effectiveness outcomes related to chronic musculoskeletal pain management in active-duty military personnel.

Clinical Study of Myofascial Trigger Points(MTrPs) Injection in the Treatment of Shoulder Osteoarthritis(OA)

Chronic musculoskeletal pain (CMP) is a common disease in China, with a high incidence among the elderly, and has a significant impact on patients' quality of life. Shoulder osteoarthritis is a common type of CMP. Currently, both domestic and international studies have confirmed that glucocorticoid injection at myofascial trigger points(MTrPs) can alleviate patients' pain symptoms. MTrPs injection is safe and easy to operate, and can improve the clinical management efficiency of patients with shoulder osteoarthritis. Therefore, we designed a prospective, randomized controlled, blinded outcome, non-inferiority study to compare the long-term clinical efficacy of glucocorticoid injection at myofascial trigger points and complex intra-articular injection in treating shoulder osteoarthritis. Patients will be randomly divided into two groups and receive either glucocorticoid injection at MTrPs or joint cavities. After treatment, patients will be followed up for 2 years. Their NRS scores, WOMAC scores, Patient Global Impression of Change(PGIC) scale, and adverse reactions will be recorded at 2 weeks, 4 weeks, 8 weeks, 12 weeks, and 24 weeks. If the results indicate that the clinical efficacy of myofascial trigger point injection for shoulder osteoarthritis is not inferior to that of injection at intra-articular injection, it will provide a safe and simple treatment option that is easy to promote for patients who do not respond to conservative treatment.

Clinical Study of Myofascial Trigger Points(MTrPs) Injection in the Treatment of Knee Osteoarthritis(OA)

Chronic musculoskeletal pain (CMP) is a common disease in China, with a high incidence among the elderly, and has a significant impact on patients' quality of life. Knee osteoarthritis is a common type of CMP. Currently, both domestic and international studies have confirmed that glucocorticoid injection at myofascial trigger points(MTrPs) can alleviate patients' pain symptoms. MTrPs injection is safe and easy to operate, and can improve the clinical management efficiency of patients with knee osteoarthritis. Therefore, we designed a prospective, randomized controlled, blinded outcome, non-inferiority study to compare the long-term clinical efficacy of glucocorticoid injection at myofascial trigger points and complex intra-articular injection in treating knee osteoarthritis. Patients will be randomly divided into two groups and receive either glucocorticoid injection at MTrPs or joint cavities. After treatment, patients will be followed up for 2 years. Their NRS scores, WOMAC scores, Patient Global Impression of Change(PGIC) scale, and adverse reactions will be recorded at 2 weeks, 4 weeks, 8 weeks, 12 weeks, and 24 weeks. If the results indicate that the clinical efficacy of myofascial trigger point injection for knee osteoarthritis is not inferior to that of injection at intra-articular injection, it will provide a safe and simple treatment option that is easy to promote for patients who do not respond to conservative treatment.

Clinical Study of Myofascial Trigger Points(MTrPs) Injection in the Treatment of Hip Osteoarthritis(OA)

Chronic musculoskeletal pain (CMP) is a common disease in China, with a high incidence among the elderly, and has a significant impact on patients' quality of life. Hip osteoarthritis is a common type of CMP. Currently, both domestic and international studies have confirmed that glucocorticoid injection at myofascial trigger points(MTrPs) can alleviate patients' pain symptoms. MTrPs injection is safe and easy to operate, and can improve the clinical management efficiency of patients with knee osteoarthritis. Therefore, we designed a prospective, randomized controlled, blinded outcome, non-inferiority study to compare the long-term clinical efficacy of glucocorticoid injection at myofascial trigger points and complex intra-articular injection in treating hip osteoarthritis. Patients will be randomly divided into two groups and receive either glucocorticoid injection at MTrPs or joint cavities. After treatment, patients will be followed up for 2 years. Their NRS scores, WOMAC scores, Patient Global Impression of Change(PGIC) scale, and adverse reactions will be recorded at 2 weeks, 4 weeks, 8 weeks, 12 weeks, and 24 weeks. If the results indicate that the clinical efficacy of myofascial trigger point injection for knee osteoarthritis is not inferior to that of injection at intra-articular injection, it will provide a safe and simple treatment option that is easy to promote for patients who do not respond to conservative treatment.