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NCT07661407
This randomized placebo-controlled trial aims to evaluate the effectiveness of High-Intensity Laser Therapy (HILT) as an adjunct to standard outpatient physiotherapy in patients with knee osteoarthritis. Seventy-two participants will be randomly assigned to receive either conventional physiotherapy combined with active HILT or conventional physiotherapy combined with sham HILT. Outcomes related to pain, knee function, physical performance, muscle strength, range of motion, psychosocial factors, quality of life and body composition will be assessed at baseline, after the intervention, and at 8-week follow-up.
NCT07642258
Osteoarthritis (OA) of the knee, also referred to as degenerative joint disease, is normally due to wear and tear and progressive cartilage loss in the articular cartilage. Osteoarthritis is most prevalent condition among older adults. The objective of the study will be to compare the effects of Sahrmann's approach versus conventional treatment on pain, valgus angle and functional disability in patients with knee osteoarthritis.
NCT07634302
Obesity is a major modifiable risk factor for knee osteoarthritis and is associated with chronic low-grade inflammation, pain, functional impairment, and cartilage degradation. Weight reduction is recommended as a core component of osteoarthritis management, while resveratrol has demonstrated anti-inflammatory and chondroprotective properties in experimental and clinical studies. However, the potential additional benefit of resveratrol supplementation when combined with dietary intervention remains uncertain. This randomized controlled trial evaluated the effects of 150 mg/day trans-resveratrol supplementation as an adjunct to a low-calorie diet in postmenopausal women with obesity and knee osteoarthritis. Ninety-seven participants were randomized to receive either a low-calorie diet alone or the same diet combined with resveratrol for 10 days. Outcomes included pain intensity, functional status, urinary C-terminal telopeptide of type II collagen (CTX-II), anthropometric parameters, body composition, metabolic markers, lipid profile, and inflammatory biomarkers.
NCT07625150
This project aims to develop an \[18F\] fluorodeoxyglucose (FDG) positron emission tomography (PET) / magnetic resonance imaging (MRI) method to locate the painful inflammation in PFJ OA associated with joint loading. \[18F\] FDG PET/MRI is an emerging pain imaging approach with enhanced sensitivity to painful hypermetabolic inflammation through evaluation of intracellular glucose utilization rate via (\[18F\]FDG PET) and fine anatomy details (MRI). The investigative group has shown its promise in revealing previously unidentified or unspecified pain generators in various musculoskeletal pain conditions. The investigators have also demonstrated the feasibility of visualizing the structural changes between unloaded and loaded knee joints with MRI, which can be easily adopted in the current PET/MRI setting. The main challenge in the proposed \[18F\]FDG PET/MRI approach is to differentiate the normal uptake of FDG for metabolic changes by weight-bearing from abnormal changes indicating eventual pain aggravation by weight-bearing and knee-flexion. The investigators have garnered the following two aims to validate the proposed method by comparing unloaded and loaded knee imaging results between PFJ OA pain patients and asymptomatic, matched controls.
NCT05112926
The purpose of this research study is to evaluate the effectiveness and safety of a permanent embolic (Embosphere Microspheres) for embolization of the geniculate artery for the treatment of moderate to severe knee osteoarthritis.
NCT07298798
Investigator study aims to compare the benefits of isometric exercise and closed kinetic chain exercises in strengthening programs to lessen pain along with enhance functionality in patients with PFP that are being associated with osteoarthritis and the assessment of PFP pertains to its recognition and the determination of significant therapeutic techniques. 70 Participants from the department of physiotherapy, Civil Hospital Karachi CHK and Dow University of Health Science (DIPMR) will be randomly assigned into two groups, an experimental group receiving closed kinetic chain exercise, and a control group receiving isometric exercises. The therapy will last four weeks, consisting of twelfth sessions. There will be 35 to 40 minutes in each session, Patients will be evaluated on primary outcome measure, pain intensity and functional limitation using various scales, including the numerical pain rating scale (NPRS) and Kujala/anterior knee pain scale (AKPS)
NCT07434011
Knee osteoarthritis is a common, chronic degenerative condition that causes pain, functional limitations, and reduced quality of life, especially in adults older than 50 years. Although clinical practice guidelines recommend therapeutic exercise and physical therapy as the first-line treatment, many patients do not receive or adhere to the recommended programs. Digital health tools may help expand access and improve adherence by supporting home-based exercise. This study is a parallel-group, randomized controlled clinical trial designed to evaluate the effectiveness of an artificial intelligence (AI)-assisted therapeutic exercise program delivered through a web-based app compared with a conventional home exercise program provided on paper in adults with knee osteoarthritis. The primary goal is to determine whether the AI-assisted program produces greater improvements in pain and knee-related function. Secondary goals include assessing changes in health-related quality of life and patient-perceived overall improvement, and comparing implementation outcomes like adherence, usability, satisfaction, self-efficacy for exercise, and use of the prescribed exercise resource (paper vs web platform). Participants will be recruited from the Department of Physical Medicine and Rehabilitation at Hospital Universitario 12 de Octubre and randomly assigned to either the AI-assisted exercise group or the conventional exercise group. The AI-assisted web app will adjust exercise dose and progression based on participant-reported pain and perceived exertion, using decision rules informed by clinical practice guidelines and high-quality research evidence. Both groups will complete a 6-week home-based exercise program and will also attend weekly in-person group sessions that will be held separately by study arm (experimental and control groups will not mix) to reduce cross-contamination and support masking procedures. These sessions will be used to address questions, reinforce the protocol, and monitor for adverse events. Clinical outcomes will include pain intensity (visual analog scale), knee-related disability and function (WOMAC), health-related quality of life (EQ-5D), and patient global rating of change (GROC). Physical performance outcomes (30-second Chair Stand Test and Stair Climb Test) will be assessed at baseline and 1 week after completion of the 6-week intervention. Assessments will be conducted at baseline, one week after the 6-week intervention, and at 3 and 6 months after the intervention, with the exception of physical performance outcomes, which will be assessed at baseline and 1 week post-intervention.
NCT07151300
Brief Summary: This single-blind, randomized controlled trial will investigate the efficacy of bee venom phonophoresis in managing pain and improving mobility in patients with knee osteoarthritis. Thirty adults aged 40-75 years with clinically and radiographically confirmed knee osteoarthritis will be randomly assigned to receive either bee venom phonophoresis or placebo phonophoresis with a neutral gel. Ultrasound parameters will be standardized for all participants. Primary outcomes are pain reduction, measured by the Visual Analog Scale (VAS), and functional mobility, assessed by the Timed Up and Go (TUG) test. The secondary outcome is walking endurance, measured by the Six-Minute Walk Test (6MWT). Assessments will be conducted at baseline and post-intervention. The study is designed to determine whether bee venom phonophoresis offers greater clinical benefit compared to placebo phonophoresis, potentially providing a non-invasive, adjunctive treatment option for knee osteoarthritis. Ethical approval has been obtained from the Faculty of Physical Therapy, Sinai University, and all participants will provide written informed consent.
NCT07066514
This study aims to evaluate the effectiveness of an artificial intelligence (AI)-supported mobile application that supervises home-based exercise programs in patients with knee osteoarthritis. A total of 80 participants aged 40 to 80 will be randomly assigned to one of two groups: a mobile application exercise group or a home exercise booklet group. Both groups will receive the same standardized stretching, strengthening, and range of motion exercises designed for knee osteoarthritis. The mobile app provides real-time feedback and supervision using the device's camera and artificial intelligence algorithms to track and guide exercise performance. Participants in the app group will perform exercises with supervision via the app interface, while the control group will follow the same exercises using printed instructions. Both groups will exercise 3 to 4 times per week for 4 weeks. The study will compare pain levels, physical function, and balance before and after the intervention using validated outcome measures such as the WOMAC Index and the Visual Analog Scale. This study may help determine whether AI-supported digital tools can improve exercise adherence and outcomes in patients with knee osteoarthritis.
NCT06647446
Osteoarthritis is a very prevalent pathology after the fifth decade of life. It usually appears in the hip and hand, although its presence in the knee is even greater, with a prevalence in subjects over 45 years of age of 19% radiographically (radiographic findings without taking symptoms into account) and 7% in the symptomatic population, for those over 60 years of age, 37% radiographic and 12% symptomatic and finally, for those over 75 years of age there was 50% of osteoarthritis of the knee diagnosed by radiographs and 33% were symptomatic. There are gender differences: the lifetime risk of suffering knee osteoarthritis is estimated at 40% for men and 47% for women. Furthermore, the impact of this pathology is significant, being the most frequent cause of gait-related disability in adults in the United States. Different approaches have been proposed for the treatment of knee osteoarthritis. Currently, clinical practice guidelines place therapeutic exercise and education as the first line of treatment, reserving joint replacement surgery in case of failure of conservative treatment and only if there is severe disability. In recent years, due to the pandemic, there has been an accelerated development of telemedicine and telerehabilitation in all its aspects. Applications and websites have been developed for online rehabilitation. An example of this is TRAK, a telerehabilitation web tool that allows the creation of a profile for each patient and the design of personalized exercise programs and the periodization of the sessions to be carried out. During the execution of the exercises, the screen of the split phone will appear, displaying on one side the execution of the exercise by a model and on the other side, the patient sees himself performing the exercise. This tool allows the monitoring of the therapeutic exercise without the need to go to a consultation or to be in front of a physiotherapist, reducing the economic and time investment. Thus, the present work tries to compare the treatment with exercises monitored by means of the TRAK application with the performance of the same exercises, without the help of this tool.
NCT07565298
This pilot trial aimed to estimate preliminary clinical effects and to assess the feasibility of adding group-based pain neuroscience education (PNE) to exercise in women aged ≥60 years with medically diagnosed knee osteoarthritis and current knee pain. Participants were randomized to either 10 weeks of community-based exercise plus PNE or exercise alone. All participants attended weekly group exercise sessions, and those in the intervention group also participated in five in-person group-based PNE sessions lasting 30 minutes each. Physical fitness tests were administered, and participants completed questionnaires assessing disability, pain intensity, and pain neurophysiology knowledge.
NCT07562646
The current study is a single-blind, parallel-group randomized controlled trial involving 18 participants with knee osteoarthritis. The trial will compare a program of two-bar knee off-load brace combined with non-weight bearing strength training with a program of standard knee off-loader brace combined with non-weight bearing strength training. Interventions will be delivered three times per week for six weeks. The primary outcomes are pain, stiffness, and patient satisfaction. Assessments will be conducted at baseline and after six weeks. The trial will be carried out at Water and Power Development Authority Hospital Complex and Fatima Memorial Hospital, Lahore. The hypothesis is that the two-bar knee off-load brace combined with non-weight bearing strength training will result in greater reductions in pain and stiffness as well as improved patient satisfaction compared with the standard knee off-loader brace with non-weight bearing strength training.
NCT04682652
The purpose of this clinical trial is to determine whether genicular artery embolization (GAE) is an effective way to treat knee pain from osteoarthritis. Pain from arthritis is often due to underlying inflammation in the joint. The inflammation is associated with increased abnormal blood flow going to the specific area of pain. If the investigator can reduce the blood flow, the inflammation can be reduced and the pain can be controlled. The GAE procedure is an experimental procedure to decrease the blood flow (embolize) to the specific region of the knee that is causing the pain. This will be done by infusing microscopic spheres into the specific blood vessel (genicular artery) supplying the area of pain in the knee. This is done through a procedure which is called an angiogram, which is done entirely through a pinhole at the creased of the thigh, using twilight (conscious) sedation. The investigators have already completed an initial trial at UCLA, and shown that this procedure is safe and effective. The purpose of this new trial is to compare outcomes of people undergoing the GAE procedure to those who do not undergo the procedure. A total of 120 patients will be enrolled, and 2/3 of the patients will be randomly selected to undergo the GAE procedure. 1/3 will not undergo the procedure. This is known as a randomized trial. During the trial, all subjects will also get MRIs and fluid withdrawn from their knee joints at various timepoints in order to precisely figure out how the procedure works on a closer (microscopic) level.
NCT06755697
Osteoarthritis (OA) is a serious worldwide public health concern, causing increased disability-adjusted life years (DALY), the reasons of which include rising prevalence of obesity and increasing older populations. The knee is one of the most easily injured joint in the body, and knee OA can become a chronic and disabling condition that pose a threat to not only the patient but also his or her caretakers and healthcare resources. The prevalence of knee OA is 5% - 15% in men over 60 years, and 10% - 25% in women aged more than 60. Knee OA can result from injuries, diseases, or wear and tear from overuse. It refers to structural changes that affect subchondral bone, articular cartilage, menisci, ligaments, synovium, and other joint structures. Currently, there are several conservative management of knee OA, including physiotherapy (therapeutic exercise, diathermy, electrotherapy), oral or topical medications, intra-articular and extra-articular injections, and radiofrequency. There are various substances used in injections for knee OA, among which are corticosteroid, platelet-rich plasma (PRP), AmnioFix, exosome, dextrose, and hyaluronic acid (HA). Compared with PRP, AmnioFix, exosome, and HA, which are not covered by the health insurance system, dextrose is a readily available and cost-effective substance. The principle of hypertonic dextrose injection, "prolotherapy", is injection of small volumes of the irritant solution at or around the lesion in order to stimulate fibroblast and vascular proliferation, local tissue healing, reduction of joint instability, thus resulting in pain relief. Previous studies have demonstrated that prolotherapy resulted in clinically meaningful sustained improvement of function and pain in knee OA, and there were no severe adverse events related to hypertonic dextrose injection. A study in 2023 showed that among various dextrose concentrations, higher concentrations demonstrated greater improvement of knee OA, thus 20% dextrose is recommended. Regarding the site of dextrose injection in knee OA, previous studies demonstrated comparable effects of intra-articular and extra-articular injections. The periarticular injections include points around the knee where periarticular nerves exit the joint capsule, and acupuncture points at upper medial and lateral parts of knee joint. A study in 2024 revealed that prolotherapy combining intra-articular with peri-articular perineural injection resulted in better pain alleviation and improvement in knee joint function in knee OA. There are several choices of imaging modality for recognizing the sites of lesion in knee OA, such as X-ray, ultrasound (US), and magnetic resonance imaging (MRI). Radiography is used to assess osteophytes, joint space narrowing, and subchondral sclerosis, but it has limited ability to detect synovial inflammation, joint effusion, soft tissue abnormalities, and early cartilage damage. US can be used to evaluate synovial fluid and cartilage thickness, but not deep structures (e.g. subchondral bone change, meniscus tear, and ACL tear, etc.). On the other hand, MRI is an optimal and accurate imaging choice for visualizing soft tissue as well as deep structures (e.g. ACL, meniscus, etc) in knee OA. The MRI findings of knee OA includes cartilage damage, meniscus tear, bone marrow lesions, synovitis, ligamentous laxity, and osteophytes. The detection of bony lesions can aid intraosseous Infiltrations, and signs of ligamentous laxity also provides target for ligaments injection. However, there is no current evidence on the effectiveness of prolotherapy targeting knee OA lesion sites according to MRI findings. Because the effectiveness of prolotherapy targeting lesion sites according to MRI findings has not been well established, the investigators aim to investigate whether injecting dextrose into MRI-positive lesion sites is more beneficial for knee OA comparing to intra-articular injections. The investigators hypothesize that MRI could be a good choice for the guidance of prolotherapy targets.
NCT07327190
This single-center randomized controlled trial aims to evaluate the effects of motor imagery and action observation training on pain, functionality, balance, and fear of movement in patients after total knee arthroplasty (TKA). The study will be conducted at Simav Doç. Dr. İsmail Karakuyu State Hospital Orthopedics Department with a minimum of 40 participants meeting the inclusion criteria. Participants will be randomly assigned to one of three groups: (1) standard physiotherapy, (2) standard physiotherapy plus motor imagery training, or (3) standard physiotherapy plus action observation training. All interventions will last six weeks. Standard physiotherapy will include ankle pumping, active-assisted hip and knee flexion, isometric and stretching exercises, cryotherapy, gait, and stair training. The motor imagery group will perform guided imagery sessions using audio recordings describing the physiotherapy exercises and daily activities. The action observation group will observe exercise videos corresponding to the physiotherapy program. The primary outcomes will include pain, functional level, balance, and kinesiophobia. The study aims to determine whether the addition of mental simulation techniques to standard physiotherapy can enhance postoperative recovery and improve functional outcomes in patients undergoing total knee arthroplasty.
NCT07544693
This study aims to examine the effects of moderate-intensity strength training, performed with or without an unloading knee orthosis (valgus-corrective or sham mode), on muscle function, motor unit behavior, and force modulation in patients with moderate knee osteoarthritis
NCT01586130
Knee osteoarthritis (O.A. from now on) is associated to muscular weakness of inferior limbs, especially the quadriceps; leading to disease progression. Advantages of muscular strength training for the treatment of this kind of O.A. is now well established. In this therapeutic field, isokinetic exercises seem to have a better efficiency than other, more frequently used, kinds of exercises such as isometric or isotonic exercises. Functional impairment caused by knee O.A. is mainly affecting walking. Walking induces muscles to work in eccentric mode. The hypothesis of this study is that muscular strengthening using isokinetic exercises in eccentric mode would have a more important benefit than isokinetic exercises in concentric mode. Such an hypothesis, if verified, could lead to a better management of rehabilitative knee exercises in the treatment of knee O.A.
NCT06000410
This study is being conducted to evaluate the efficacy and safety of ASA compared to placebo in the management of osteoarthritis (OA) symptoms of the knee.
NCT07539948
Problem: Total knee replacement (TKR) surgeries are increasing due to ageing populations. Current rehabilitation has a gap - patients do unsupervised exercises at home for 2-3 weeks between hospital discharge and outpatient appointments, leading to poor compliance and complications. Current Issues: 25% of patients don't achieve meaningful functional improvement for 6+ months, and 20% still have significant limitations after 2 years. Proposed Solution: Deploy a robot-aided device for intensive, self-paced home rehabilitation exercises to help patients return to near-normal function within 1 month. Goals: Improve early functional recovery, increase exercise compliance, reduce costs, and enhance long-term quality of life for knee osteoarthritis patients.
NCT07225829
This phase 2a trial is an international, multicenter, randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of one single intra-articular (IA) injection of 4P004 or placebo in: * patients between 40 and 80 years of age, * with synovitis and grade 2 to 4 osteoarthritis (OA) of the knee according to Kellgren and Lawrence (KL) classification.