Clinical Research Directory

Comparative Effect of Dual Task Training and Rhythmic Stabilization in Knee Osteoarthritis Patients

Knee osteoarthritis (KOA) is a degenerative joint condition that causes pain, stiffness, reduced proprioception, impaired balance, and decreased physical function. This study aims to compare the effects of Dual Task Training and Rhythmic Stabilization Training on balance, proprioception, and physical function in patients with KOA. A randomized clinical trial will be conducted using convenient sampling, with participants randomly allocated into two groups. Both groups will receive a 15-minute hot pack followed by their respective interventions, three times per week for six weeks,12 sessions.

Biomechanical and Clinical Evaluation of a Gait Modifying Device for Treating Knee Pain

The goal of this clinical trial is to determine if gait-modification therapy via custom shoe intervention can reduce knee pain and improve gait parameters in individuals experiencing chronic (\>6 month) knee pain. The main questions it aims to answer are: * Do patient-reported outcomes related to knee pain improve with the use of gait-modifying shoes? * Do gait-modifying shoes change gait parameters (speed, step length, single limb support, and symmetry)? Participants will: * Attend an initial assessment and treatment visit lasting less than 2 hours. * Wear gait-modifying shoes daily for 12 weeks, gradually increasing the duration of wear as prescribed. * Record the daily time worn and pain levels on a provided chart. * Attend three follow-up visits, each lasting less than 1 hour, for treatment adjustments and data collection.

Tempo-controlled Low-load Resistance Training in Patients With Knee Osteoarthritis.

This randomized controlled trial aims to evaluate the effects of tempo-controlled low-load resistance training compared to conventional low-load resistance training on pain, muscle performance, and functional disability in patients with knee osteoarthritis. The study will recruit 32 participants aged 40-65 with Grade I-II knee osteoarthritis and randomly allocate them into two groups for a 6-week intervention at Ch Rehmat Ali Memorial Trust Hospital. Group A will perform strengthening exercises (such as sit-to-stand, mini squats, and leg raises) using a controlled 3-1-3 second tempo cadence (eccentric, isometric hold, concentric), while Group B will perform the same exercises at a self-selected speed; both groups will receive preparatory moist heat, warm-ups, knee isometrics, and Maitland mobilizations three times weekly. Primary outcomes-including pain intensity (NPRS), functional difficulty (WOMAC), walking endurance (6MWT), and mobility (TUG)-will be evaluated at baseline and 6 weeks to determine if tempo control offers a more effective, well-tolerated alternative for managing knee osteoarthritis.

Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis

Genicular Artery Embolization for Reducing Pain in Symptomatic Knee Osteoarthritis: A Pilot Randomized Sham-Controlled Study (SHAM-PAIN) is a NIH-NIAMS funded project designed to assess enrollment feasibility and detect any differences between GAE and a similar sham intervention in reducing KOA-related pain at 3 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscore. Additionally, this study aims to determine the magnitude of difference in pain response between GAE and sham to adequately power a larger, more definitive randomized sham-controlled trial (RCT). The influence of psychosocial and psychocognitive factors, changes in analgesic use, and conditions of knee joint cartilage and effusion will similarly be explored to determine their impacts on perceived pain response to GAE.

Patient Centered Post-Op Pain Management Software Tool Interventional Study Verses Standard of Care

The goal of this clinical trial is to learn if the Pain Coach App will result in less opioids being prescribed to and used by patients undergoing Shoulder/Hip/Knee Arthroplasty surgery while maintaining the same or better pain control versus standard of care. The main questions it aims to answer are: 1. Will elective shoulder, hip and knee arthroplasty patients using PainCoach App be prescribed and/or use less opioids, measured by total morphine milliequivalents (MME) after surgery when compared to those treated as standard of care while maintaining similar pain control? 2. Will arthroplasty surgeons using PainCoach App write more patient-specific prescriptions resulting in a reduction in opioids prescribed after surgery with no increase in further opioids prescribed in the months following surgery? 3. Will the use of Pain Coach App lead to equal or reduced healthcare system utilization after surgery? 4. Will patients and surgeons using PainCoach App find it helpful enough to use it again and recommend to colleagues, family and friends? Researchers will compare participants assigned to use Pain Coach App vs participants assigned to standard of care arm to see if there are differences in opioid prescriptions and self reported use. Participants will either use the Pain Coach App or follow standard of care instructions and be followed forward for the opioid prescriptions dispensed in community and self-reported opioids use at study end.

Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders

This pilot randomized controlled trial aims to compare the clinical effectiveness of advanced high-intensity physical therapy modalities with conventional physical therapy in patients suffering from musculoskeletal disorders. The study focuses on three anatomical areas: lower back, shoulder, and knee. Participants will be randomized into two arms and will undergo 5 therapeutic sessions.

Exercise Plus Duloxetine for Knee Osteoarthritis

This study evaluates the addition of duloxetine to aerobic exercise in the treatment of symptomatic knee osteoarthritis and depressive symptoms in adults. All participants will receive the receive the treatment protocol, which will first be evaluated in terms of feasibility and then pilot tested.

Evaluation of the Effect of Biofiller PRP Application on Knee Osteoarthritis

The aim of this study is to evaluate the effects of biofiller PRP on function, pain level, and femoral cartilage thickness in knee osteoarthritis: a randomized clinical study

Genicular Nerve Radiofrequency Ablation Versus Hyaluronic Acid Injection for Knee Osteoarthritis Pain

The goal of this clinical trial is to learn if thermal radiofrequency ablation of the genicular nerves (the nerves that carry pain signals from the knee) works better than a single injection of hyaluronic acid into the knee to relieve pain in adults with knee osteoarthritis who have not improved with conservative treatment. The study also includes patients with severe knee osteoarthritis who are not candidates for knee replacement surgery. The main questions it aims to answer are: * Does genicular nerve radiofrequency reduce knee pain during movement more than hyaluronic acid over 12 months? * Does it improve knee function and quality of life, and does its effect last longer? Researchers will compare radiofrequency ablation with hyaluronic acid injection to see which treatment gives greater and longer-lasting pain relief. Participants will: * Be randomly assigned to one of the two treatments. * If assigned to radiofrequency, first receive a diagnostic nerve block with local anesthetic. Only those whose pain decreases by at least 50% will then receive radiofrequency ablation, in a single ultrasound-guided session. * If assigned to hyaluronic acid, receive a single injection of hyaluronic acid into the knee. * Attend follow-up visits at 1, 3, 6 and 12 months, where they will rate their pain and answer questionnaires about knee function, overall status and quality of life.

Platelet-Rich Plasma, Hyaluronic Acid, or Their Combination for Knee Osteoarthritis in Athletes

The goal of this clinical trial is to learn whether a single knee injection of platelet-rich plasma (PRP) combined with hyaluronic acid (HA) works better than PRP alone or HA alone to relieve pain and improve function in physically active adults (athletes) with knee osteoarthritis. The main questions it aims to answer are: * Does PRP combined with HA improve the WOMAC total score at 12 months more than PRP alone? * How do PRP plus HA, PRP alone and HA alone compare regarding pain, function, sports activity, global improvement, satisfaction, use of rescue medication and adverse events over 24 months? Researchers will compare three groups: PRP plus HA, PRP alone and HA alone. The PRP will be leukocyte-poor, prepared fresh, standardized to at least 1,000,000 platelets per microliter and a total dose of at least 5 billion platelets, and fully characterized according to the MIBO checklist and the AAOS/NIH minimum reporting standards. Participants will: * Have a blood sample collected (all groups, so that participants do not know which treatment they receive) * Receive one ultrasound-guided injection in the target knee * Answer questionnaires (WOMAC, KOOS, IKDC, Lysholm, Tegner and pain scale) at baseline and at 3, 6, 12 and 24 months * Report any pain medication used, other treatments and side effects during follow-up

Exploration of Appropriate BIS Range and Propofol Effect-site Concentration During Total Intravenous Anesthesia With Concomitant Adjuvants.

The goal of this clinical trial is to determine the appropriate Bispectral Index (BIS) range and propofol effect-site concentration required to maintain adequate anesthesia depth during total intravenous anesthesia (TIVA) combined with midazolam, dexmedetomidine, or esketamine in patients undergoing unilateral knee replacement surgery. The main questions it aims to answer are: 1. What are the appropriate BIS range and propofol effect-site concentration for maintaining adequate anesthesia depth when combined with each of the three medications (midazolam, dexmedetomidine, or esketamine) during TIVA? 2. How these combination regimens affect the quality of recovery and postoperative pain in patients？ Participants will: 1. Receive one of four anesthesia regimens during surgery: propofol alone, propofol combined with midazolam, dexmedetomidine, or esketamine. 2. Undergo a stepwise reduction of propofol effect-site concentration towards the end of surgery. 3. Have their consciousness assessed using the isolated forearm technique, while BIS, EEG signals, and vital signs are continuously monitored throughout the procedure. 4. Have their recovery quality and postoperative pain assessed after surgery.

The Effect of Theory-driven Physiotherapy on Physical Activity in Knee OA.

Knee osteoarthritis (OA) is a leading cause of pain, disability, and reduced physical functioning worldwide. Although physiotherapy and physical activity are recommended as first-line treatments, many individuals with knee OA do not achieve or maintain recommended levels of physical activity. As a result, the benefits of evidence-based physiotherapy are often not fully realized. To improve physical activity participation, effective behaviour change interventions are needed. Theory-informed interventions have the potential to enhance physiotherapy outcomes by targeting the psychological determinants that influence physical activity behaviour. One well-established framework is the Theory of Planned Behaviour (TPB), which proposes that behaviour is primarily influenced by behavioural intention, attitude, subjective norms, and perceived behavioural control. To translate these determinants into intervention content, behaviour change techniques (BCTs) can be systematically selected using tools such as the Behaviour Change Intervention Ontology (BCIO), Mechanisms of Action Ontology (MoAO), and Theory and Techniques Tool (TaTT). This approach may improve the effectiveness and sustainability of behaviour change interventions. The present study therefore aims to evaluate the potential of a TPB-based behaviour change intervention as an addition to guideline-recommended physiotherapy for individuals with knee OA. The primary objective is to determine whether this theory-driven intervention can improve physical activity levels and reduce sedentary behaviour. A secondary objective is to explore the behavioural mechanisms through which these changes occur. The study will employ a randomized, concurrent, multiple-baseline single-case experimental design (SCED). Participants with knee OA will receive a six-week physiotherapy intervention consisting of usual guideline-based care supplemented with a TPB-based behaviour change component. Physical activity and sedentary behaviour will be continuously assessed using ActiGraph accelerometers. In addition, behavioural determinants, pain, and functional limitations will be repeatedly measured to evaluate potential mechanisms of action and clinical effects. Findings from this study may contribute to the development of more effective, theory-informed physiotherapy interventions aimed at promoting sustainable physical activity behaviour in people with knee OA.

Autologous Adipose-Derived Stem Cell Injections for Knee Osteoarthritis

This multicenter, prospective, randomized, active-controlled, single-blind (assessor-blinded) clinical trial aims to evaluate the efficacy and safety of intra-articular injection of autologous adipose-derived mesenchymal stem cells (ADMSCs) compared with active comparator hyaluronic acid (HA) in patients with Kellgren-Lawrence grade II to III knee osteoarthritis. A total of 165 participants across 3 centers (Severance Hospital, Seoul National University Hospital, Inha University Hospital) will be randomly allocated to either the ADMSC group (1.0 x 10\^8 cells, single injection) or the HA group (Synovian, 3 mL) in a 2:1 ratio and followed for 6 months post-injection.

Comparison of Music and Ambient Noise Cancellation in Patients Undergoing Total Knee Arthroplasty (TKA)

The aim of this clinical trial is to compare the effects of music and ambient noise cancellation during total knee arthroplasty and to analyse the effects on patients. The study will also collect information on patients' functional knee scores and anxiety levels. The main questions to be answered are the following: Does the blocking of music or ambient noise, which is predicted to reduce anxiety, reduce people's anxiety levels? To what extent are participants affected by ambient noise? Does music or ambient noise blocking lead to an improvement in patients' functional scores? The researchers will work with 3 groups of patients who will be exposed to ambient noise blocking, music playing and ambient noise during knee replacement surgery. Participants will do the following: Be asked questions about anxiety and knee function scores before and after surgery. Attend clinical examinations at specified times for checks and tests. Outcomes will be assessed and recorded at appropriate times.

Effects of Music During Walking on Pain and Muscle Activation in People With Chronic Pain Due to Knee Osteoarthritis

The purpose of this research study is to compare muscle activation, changes in pain sensitivity, and brain function, between different walking conditions, including walking to music, walking to metronome, and walking without music or metronome.

Decompression Versus Heat and Decompression in Knee OA

a randomized controlled trial tends to compare the effects of adding superficial heating during the application of knee decompression session to the results of decompression alone without heating.

Efficacy and Safety of Celecoxib/Acetaminophen Versus Celecoxib for Diagnosed Osteoarthritis in Acute Exacerbation

This is a Phase III, longitudinal, multicenter, randomized, double-blind clinical trial designed to evaluate the efficacy and safety of a fixed-dose combination of celecoxib and acetaminophen compared to celecoxib monotherapy for the treatment of pain associated with acute exacerbations of osteoarthritis.

A Trial to Investigate the Safety and Efficacy of Intra-articular 4P004 Injection in Subjects With Knee Synovitis and Osteoarthritis

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.

Effects of Low-Load Blood Flow Restriction Resistance Training With and Without Hip Abductor Strengthening in Patients With Knee Osteoarthritis.(BFR)

This study aims to compare the effects of low-load Blood Flow Restriction (BFR) resistance training with and without hip abductor strengthening in patients with knee osteoarthritis. It will evaluate the effectiveness of both treatment approaches in reducing knee pain, improving range of motion, increasing muscle strength, and enhancing functional ability. The study will determine which intervention provides better clinical outcomes in patients with knee osteoarthritis.

Sensor-based Physiotherapy Intervention With Virtual Reality

This study is looking at the how the use of non-immersive virtual reality technology can be used to help people that have pain in their knees caused by osteoarthritis. It is a feasibility randomised controlled trial to investigate the feasibility of the use of the intervention by patients in their homes in a larger randomised controlled trial. The intervention is a non-immersive virtual reality system. Through the use of painless sensors, patients are able to control an animated character on a screen through a series of games that replicates real physiotherapy exercises used to treat knee osteoarthritis. This intervention is being compared to a standard care physiotherapy programme. As this is a feasibility study, it has no single primary outcome. Instead, the main outcome measures relate to feasibility of the study. This includes; feasibility of recruitment, completeness of outcome measures, the fidelity of healthcare professionals delivering the intervention, the acceptability of the intervention and trial procedures, adverse events, and adherence of the intervention. Patients are randomised to receive either the intervention or control, and then spend 12-weeks in their assigned treatment. They then receive a 12-week and a 24-week follow up. Patient interviews are offered for those in the intervention arm to collect qualitative data regarding acceptability of the intervention and their participation in the study.

Cannabinoids vs. Placebo on Persistent Post-surgical Pain Following TKA: A Pilot RCT

Each year, approximately 75,000 Canadians undergo knee replacement surgery, and up to 25% develop persistent post-surgical pain. Persistent post-surgical pain is associated with depression, anxiety, unemployment, and reduced quality of life. Chronic pain after surgery is often managed with opioid therapy, which typically provides only modest benefits and is associated with rare but serious adverse events, such as overdose and death. A number of studies have found that greater pain just before and after knee replacement surgery is associated with the development of chronic pain, suggesting that reducing peri-operative pain may help prevent persistent post-surgical pain. Medicinal cannabis has begun to emerge as a potential therapy for pain reduction, and produces effects largely due to 2 active components: (1) cannabidiol (CBD), and (2) tetrahydrocannabinol (THC). Studies of CBD have shown analgesic, anti-inflammatory, and anti-anxiety properties, but without the psychoactive effects (feeling 'high') that THC produces. This study will assess the feasibility of a definitive trial to explore whether adding CBD dominant vs. placebo to usual care before and after surgery can reduce the rate of persistent post-surgical pain after total knee replacement. This study will randomize 40 patients to receive either CBD dominant or placebo, and follow them for six months to confirm our ability to recruit patients, adhere to protocol, and capture full outcome data for at least 85% of patients.

Effects of Visual and Vestibular Rehabilitation in Individuals With Knee Osteoarthritis

This study aims to investigate the effects of visual rehabilitation and vestibular rehabilitation added to conventional physiotherapy on postural stability, pain, and functional status in individuals with knee osteoarthritis. Participants will be randomly assigned to three groups: conventional physiotherapy, conventional physiotherapy combined with visual rehabilitation, or conventional physiotherapy combined with vestibular rehabilitation. The study will evaluate changes in balance, pain, and functional performance before and after the intervention.

Comparison of the Therapeutic Effects of Lyophilized Platelet-rich Plasma Lysate and Dextrose Prolotherapy in Knee Osteoarthritis

The goal of this clinical trial is to compare the therapeutic effects of lyophilized platelet-rich plasma lysate and dextrose prolotherapy in patients with knee osteoarthritis (OA). The main questions it aims to answer are: * Does lyophilized platelet-rich plasma lysate improve pain, physical function, and muscle strength in patients with knee osteoarthritis? * Is lyophilized platelet-rich plasma lysate more effective than dextrose prolotherapy in improving clinical outcomes in patients with knee osteoarthritis? Researchers will compare patients receiving lyophilized platelet-rich plasma lysate with those receiving dextrose prolotherapy to evaluate differences in treatment effectiveness. Participants will: * Receive intra-articular injections of either lyophilized platelet-rich plasma lysate or dextrose prolotherapy. * Undergo clinical assessments before and after treatment, including the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) to evaluate pain, stiffness, and physical function. * Undergo knee X-ray examinations to assess osteoarthritis severity using the Kellgren-Lawrence (KL) grading system. * Undergo isokinetic muscle strength testing using a Biodex dynamometer to evaluate knee muscle strength.

Effect of TECAR Therapy on Balance and Quality of Life in Elderly Men With Knee Osteoarthritis

Evaluate the effect of TECAR therapy combined with traditional physiotherapy on pain, balance, and quality of life in elderly men with knee osteoarthritis .