Clinical Research Directory

Platelet Rich Plasma Injections In Young And Old Human Subjects

This is a randomized, double-blind, placebo-controlled phase 2 study with a secondary crossover phase at the end of the initial trial to ensure all subjects receive one PRP injection. The goal is to identify what proteins change in the blood following repeated intraarticular knee PRP injections in patients with knee osteoarthritis. The objective is to determine the protein changes resulting from a single autologous PRP injection (5 mL) in comparison to a normal saline control. About 60 subjects will take part in this study by two age groups at UCSF into the following arms: Arm A: PRP injection; Arm B: normal saline injection control. The study aims to demonstrate what benefits PRP has on knee osteoarthritis and methods to best achieve biologic effects. Subjects with a diagnosis of knee osteoarthritis ages 18-45 and 46-70 years old presenting to a University Based sports medicine clinic will be screened for potential eligibility. Subjects who meet all qualifying requirements will be recruited from UCSF's orthopedic and primary care clinics. Subjects will be on study for up to 26 weeks Screening: up to 14 days Treatment: injection of PRP or normal saline; subjects can cross over at week 12 to a PRP if originally in the control injection group Follow-up: 2 weeks post-baseline injection, 12 weeks postbaseline, (14 weeks if crossover patient), 26 weeks.

Workstation Ergonomics Program at Al-Baha University

This study evaluates a workstation ergonomics program at Al-Baha University aimed at reducing work-related musculoskeletal symptoms among university employees who use computers regularly. The program includes an ergonomics self-assessment of the workstation, individualized guidance on proper workstation setup and posture, and practical recommendations to improve daily work habits. Participants will be followed for approximately four weeks, and changes in musculoskeletal symptoms and related outcomes will be assessed before and after the program, compared with a usual-practice control group.

Mobile App-Assisted Home Exercise for Musculoskeletal Disorders

Overview This study evaluates the effectiveness of a dedicated mobile health (mHealth) application in supporting home exercise programs for patients with musculoskeletal disorders, such as neck, shoulder, back, or knee pain. The research aims to address the widespread challenge of low patient adherence to unsupervised home-based exercises. Study Design The project employs a dual-methodology approach: Clinical Trial: 30 participants presenting with neck, shoulder, back, or knee pain will be randomly assigned to either an app-assisted group or a traditional home exercise group. Both groups will undergo 4 weeks of physiotherapy. The study will compare pain intensity, physical function, and exercise adherence between the two cohorts. Retrospective Analysis: To complement the trial, the study will analyze a large-scale database containing approximately 700,000 anonymized real-world data entries. This analysis aims to observe real-time pain fluctuations before and after exercise sessions within routine clinical settings. Goal The primary objective is to determine if integrating mHealth technology into traditional rehabilitation can enhance clinical outcomes and improve patient adherence to home-based exercise routines.

Evaluation of Biomechanical Forced During the Practice of Endoscopic Submucosal Dissection

The prevalence of musculoskeletal disorders (MSDs) among endoscopists is estimated between 29 and 89%. The most common disorders are carpal tunnel syndrome, De Quervain tenosynovitis, lateral epicondylitis and neck pain. Factors associated with MSD among gastroenterologists practicing endoscopy are: the high number of procedures (more than 20/week), the procedure time (more than 16 hours/week) and the number of years of practice.With the evolution of digestive endoscopy superficial cancer can endoscopically be removed by endoscopic submucosal dissection (ESD) avoiding surgical resections. The number of procedures is increasing, with longer examination times in case of ESD (about 2 hours). This volume of hours and procedures may in the near future further increase the risk of MSDs in the population of gastroenterologists. Some good practice recommendations have been proposed to improve practitioner comfort, similar to what is recommended for digestive surgeons. It is recommended to use a height-adjustable examination table, position the screen at eye level, and use a seat during the procedure. There is little data on the biomechanical forced experienced by an endoscopist when performing endoscopy and colonoscopy, and none when performing ESD. The aim of this study is to evaluate the biomechanical forced experienced by the gastroenterologist during an ESD the practice of submucosal dissection.

Manual Therapy and Physical-sport Performance

The study aims to observe the influence of manual therapy on physical and sporting performance. Manual therapy and physiotherapy have always been associated with post-exercise or as a means of recovering from injuries. The objective is to see if a physiotherapy intervention based on manual therapy causes changes in physical and sporting performance. To do this, after a brief warm-up, a series of sports tests will be carried out, where the investigators will measure variables such as strength, range of motion, and autonomic nervous system parameters. Subsequently, a series of techniques will be applied in various anatomical regions, and finally, the sports tests will be repeated, and the results will be compared.

Observational Prospective PMCF Study to Confirm Performance and Safety of Intelect® Devices in Real World

DJO UK Ltd (ENOVIS) is conducting this study to confirm the performance and safety of the Chattanooga Intelect® devices in real world use. This study will record post market clinical data on the use of a number of MDR-CE marked devices that are part of the Chattanooga Intelect® device family to ensure the continued acceptability of the benefit-risk ratio, and to identify possible systematic misuse or off-label use of the devices (Intelect® Mobile 2 Combo, Intelect® Mobile 2 Ultrasound, Intelect® Mobile 2 Electrotherapy (Stim), Intelect® Transport 2 Combo and Intelect® Transport 2 Ultrasound).

Analysis of Neuromodulation as a Complementary Treatment to Evidence-based Clinical Intervention in Subjects With Musculoskeletal Pathology of the Lower Limb: a Double-blind Randomized Clinical Trial

This project aims to analyze the use of neuromodulation within a treatment protocol for musculoskeletal conditions of the lower limb, as well as to determine the difference between two and three sessions per week. Study participants will be divided into four intervention groups: the first will receive two sessions per week for a period of six months, while the second will receive three sessions per week for the same period. The treatment protocol will consist of therapeutic physical exercise focused on the muscles and joints of the lower limb, stretching of the involved muscles, and neuromodulation of the nerve root of the lumbosacral plexus, which innervates the affected structures. The third and fourth intervention groups will receive the same treatment as mentioned above, but without neuromodulation. The third group will receive three sessions per week, while the second group will receive two sessions per week. Two different types of measurement variables will be used: objective variables will be used to measure range of motion and muscle strength. Subjective variables will also be used through validated questionnaires, covering physical activity, health-related quality of life, lower limb function, and a visual analog scale for pain perception.

Analysis of Neuromodulation as a Complementary Treatment to Evidence-based Clinical Intervention in Subjects With Musculoskeletal Pathology of the Upper Limb: a Double-blind Randomized Clinical Trial

This project aims to analyze the use of neuromodulation within a treatment protocol for musculoskeletal conditions of the upper limb, as well as to determine the difference between two and three sessions per week. Study participants will be divided into four intervention groups: the first will receive two sessions per week for a period of six months, while the second will receive three sessions per week for the same period. The treatment protocol will consist of therapeutic physical exercise focused on the muscles and joints of the lower limb, stretching of the involved muscles, and neuromodulation of the brachial plexus nerve root, which innervates the affected structures. The third and fourth intervention groups will receive the same treatment as mentioned above, but without neuromodulation. The third group will receive three sessions per week, while the second group will receive two sessions per week. Two different types of measurement variables will be used: objective variables will be used to measure range of motion and muscle strength. Subjective variables will also be used through validated questionnaires, covering physical activity, health-related quality of life, upper limb function, and a visual analog scale for pain perception.

Effect and Cost of a Physiotherapy-led Care Model in Emergency Departments for Patients With Minor Musculoskeletal Injuries

Both in Denmark and internationally, emergency departments have been overwhelmed for several years by a growing number of patients, combined with a shortage of doctors and nurses. This problem is expected to continue because the number of elderly people with multiple health problems is increasing. To keep providing good quality care in emergency departments, we need to consider new ways of organizing treatment. In Canada, Australia, and the UK, some hospitals have tried a model where specially trained physiotherapists examine and treat patients who come in with muscle and joint injuries and pain. Since these patients make up about 25% of all those referred to emergency departments, this model could help take some pressure off doctors and nurses. That way, doctors and nurses can spend more time caring for seriously ill patients who need urgent help. Several studies on these physiotherapist-led models show benefits for both patients and the healthcare system. Patients report being more satisfied and better informed about their injury and treatment. They wait less, have fewer unnecessary tests, and need fewer repeat visits to the emergency department. However, similar studies have never been done in Scandinavia, even though some Danish emergency departments have tested similar models. Healthcare systems and the education of physiotherapists differ between Scandinavian countries and the countries mentioned above. So, we don't know if we would see the same benefits here. Also, there has been no research on whether this model is cost-effective, which is important for decision-makers when planning future healthcare budgets. With this research project, we want to test a model in Danish hospitals where specially trained physiotherapists take care of examining, treating, and discharging patients with muscle and joint pain and injuries. We will look at how this model affects patient experiences (like pain and satisfaction) and clinical outcomes (like repeat emergency visits and use of imaging tests), compared to the usual practice where doctors handle these patients. We will also study whether the model is cost-effective, meaning whether the benefits of using this approach are worth the costs, or even greater than the costs. The study will be conducted at 4-5 hospitals, where a total of 800 patients with minor musculoskeletal injuries will be included in connection with their visit at the emergency department. Patients will receive questionnaires at 1, 4, 12 and 26 weeks after injury regarding patient reported outcomes. Register data will be retrieved at 26 weeks regarding the patients' health care use during follow-up.

PRISM: The PRimary Care Individual Social Norms MSK Data Dashboard: a Feasibility Trial

Background: 20 million people in UK have musculoskeletal (MSK) aches and pains. They commonly see their GP about this problem, but practices are so busy that it can mean a long wait for appointments. First Contact Practitioner (FCPs) are now working in the GP practices to see patients with MSK problems instead of their GP. A national evaluation has found this to be working well. For FCPs working in GP practices there is more clinical risk. The patients have not been previously screened by a doctor to ensure there is no medical cause for their pain. The Chartered Society of Physiotherapists (CSP) has advised that all FCPs be clinicians with the highest level of experience, known as Advanced Practitioners. However the demand for FCPs far outweighs the number of Advanced Practitioners available so physiotherapists being hired have less experience. Evidence shows that clinicians of different experience levels have different decision-making strategies which may cause unwarranted variation in care. A new method is needed for oversight and support of the FCPs. Clinical supervision is commonly utilised in the NHS and in physiotherapy teams. It is a space to reflect on a clinician's performance and create learning opportunities. This research suggests an individual data dashboard, shared only with individuals and their supervisor, that feeds back a clinician's own decision-making data to them, relative to their peers. For example, the participant is "in the top 20% of MRI requesters" or "in the top 20% of those referring to social prescribing". This type of feedback is known as 'social norms' feedback. It has been proven to be an effective way to change healthcare workers behaviour. The intervention will be called PRISM: Primary Care Individual Social Norms MSK Data Dashboard. Aims To explore the feasibility of a randomised clinical trial comparing the clinical decision-making behaviour of FCP services using the PRISM Dashboard and a usual service with no clinician feedback. Design \& Methods: This research is a feasibility trial, a process to assess whether a future full scale clinical trial within the NHS would work. It will take place across 4 different Primary Care commissioning areas to determine the possibility of recruitment, retention, outcome collection and whether people will use the intervention. PPIE for this research included one primary care PPI rep, one digital interventions PPI rep and 3 Healthwatch PPI reps. Engaging different PPI sources enabled participation from different social , cultural and ethnic backgrounds. Dissemination I will communicate research updates and outputs in conferences, via social media, blogs, newsletters and podcasts. I will use my own network as well as the reach of collaborators in this work, ie. Healthwatch, NHS England/Improvement, The (CSP), the physiotherapy digital network, Keele University and UCL research networks.

Effects of Musculoskeletal Rehabilitation Courses on Work Ability

The goal of this observational study is to learn about the effects of two different musculoskeletal rehabilitation programs in working-age people with musculoskeletal disorders. The main question it aims to answer is: Do musculoskeletal rehabilitation programs A or B improve work ability in people with musculoskeletal disorders? Participants starting in rehabilitation programs A and B will answer survey questions about their work ability and related factors three times: when starting, immediately after the rehabilitation ends, and 4 months after ending the rehabilitation. Participants in study group C will answer the same questions during the same time period. Researchers will compare participants in rehabilitation programs A and B to participants in group C, who have musculoskeletal disorders but will not participate in rehabilitation programs. The comparison is done to see if there are differences in the changes in work ability and related factors, such as pain or quality of life.

Prevalence of Musculoskeletal Disorders

This observational cross-sectional study aims to determine the prevalence of musculoskeletal disorders (MSDs) among Egyptian students in the Faculty of Applied Arts. Using the Arabic version of the extended Nordic Musculoskeletal Questionnaire (NMQ-E), the study will assess the prevalence, distribution, and associated factors of musculoskeletal symptoms over the last 12 months and 7 days. A sample of 250 participants, aged 20-22 years and of both genders, will be recruited. Exclusion criteria include obesity, pregnancy, history of neuropathy, unstable medical conditions, or trauma-related musculoskeletal problems. The results will provide insights into MSD prevalence and help guide interventions for this population.

Mesenchymal Stem Cells for the Treatment of Various Chronic and Acute Conditions

This multi-arm, multi-site study investigates the safety, tolerability, and efficacy of stem cell therapy for the treatment of various acute and chronic conditions. Clinically observed initial findings and an extensive body of research indicate regenerative treatments are both safe and effective for the treatment of multiple conditions.