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Knee Osteoarthritis clinical trials

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NCT ID: NCT04343716 Completed - Knee Osteoarthritis Clinical Trials

Investigating Racial Differences in Diet Benefits for Knee Osteoarthritis

Start date: October 1, 2020
Phase: N/A
Study type: Interventional

Knee osteoarthritis (OA) is the most prevalent form of arthritis and race is a risk factor for poor outcomes. African-Americans (AAs) report greater OA-related disability and pain severity compared to their Non-Hispanic White (NHW) counterparts. These disparities are reinforced through social and biological mechanisms, ultimately resulting in dramatic racial disparities in pain experience and associated quality of life. Low-carbohydrate diets (LCDs) reduce inflammation and pain independent of weight loss, but significant racial differences exist in metabolism that are rarely addressed in diet interventions. The overall objective of the proposed study is to determine whether the beneficial effects of an LCD for knee OA pain are related to race. The investigators will recruit 20 adult women (65-75) with knee OA with equal representation across racial groups (10 AA, 10 NHW). Following one week of diet and pain self-report, the investigators will assess quality of life, depression, experienced pain and evoked pain. Participants will be placed on a LCD wherein all meals and snacks will be delivered weekly after consult with study personnel. Participants will return every 3 weeks for testing during the 12-week intervention with blood drawn at baseline and at the conclusion of the 12-week diet. Blood will be assayed for oxidative stress markers. This will be the first assessment of racial differences in the efficacy of a LCD to reduce knee OA pain. Objective 1: To determine whether the LCD reduces pain after 12 weeks. Hypothesis: The LCD will significantly reduce evoked and self-reported pain. Objective 2: To determine whether the benefits of the LCD differ based on race. Hypothesis 1: The LCD will reduce evoked and self-reported pain more in AA than in NHW. Hypothesis 2: AAs will experience greater improvements in depression, quality of life, pain interference and show more weight loss than NHWs. Objective 3: To determine whether the LCD has a differential impact on oxidative stress by race. Hypothesis 1: The LCD will significantly reduce oxidative stress over 12 weeks. Hypothesis 2: AAs will show greater reductions in oxidative stress than NHWs. The reduction in oxidative stress will be correlated with reduction in evoked pain.

NCT ID: NCT04339504 Recruiting - Knee Osteoarthritis Clinical Trials

Follow-up Safety and Efficacy Evaluation on Subjects Who Completed Phase I Clinical Trial

Start date: April 14, 2020
Phase: Phase 1
Study type: Interventional

This is a follow-up study to investigate the long-term safety and explore efficacy of SMUP-IA-01, for the treatment of Knee Osteoarthritis. Subjects who participated in and completed the initial stage of the Phase I trial (NCT04037345 ) will be followed-up until 60 months.

NCT ID: NCT04334278 Completed - Obesity Clinical Trials

Development of a Mind Body Program for Obese Knee Osteoarthritis Patients With Comorbid Depression

GetHealthy-OA
Start date: August 23, 2021
Phase: N/A
Study type: Interventional

Knee osteoarthritis (OA) is the most common joint disorder in the U.S. and a leading cause of disability. Depression and obesity are highly comorbid among knee osteoarthritis patients, and the combination of obesity and depression is associated with decreased physical activity, higher pain and disability, and more rapid cartilage degradation. Depression, obesity and osteoarthritis exacerbate one another and share a common pathophysiology involving systemic inflammation and pro-inflammatory cytokines, reflecting a complex mind-body interaction. Current treatments for knee osteoarthritis offer little to no benefit over placebo, and do not emphasize mind-body practices or physical activity to target the underlying pathophysiology. Mind-body interventions to lessen depressive symptoms and increase physical activity offer the ability to target biological, mechanical and psychological mechanisms of osteoarthritis progression in this high-risk subset. The long-term goals are to evaluate the mechanisms by which the Relaxation Response Resiliency Program (3RP) delivered via telehealth, and adapted for patients with depression, obesity and knee OA (GetHealthy-OA) promotes increases in physical activity and improved subjective and objective aspects of knee health. The overarching hypothesis is that the synergistic interaction between mindfulness, adaptive thinking, positive psychology and healthy living skills of the GetHealthy-OA will reduce pro-inflammatory cytokine expression while also promoting optimal mechanical loading of the cartilage thereby slowing the progression of symptomatic knee osteoarthritis. This study aims to adapt the 3RP for the needs of knee osteoarthritis patients with depression and obesity with a focus of increasing physical activity, and iteratively establish the feasibility, credibility and acceptability of the programs and research procedures.

NCT ID: NCT04331990 Not yet recruiting - Knee Osteoarthritis Clinical Trials

The Distraction of Knee Joint to Alleviate osteoArthritic Pain (DiKAP) Trial

DiKAP
Start date: September 2021
Phase: N/A
Study type: Interventional

This is a randomized controlled trial examining the short- and long-term effects of mechanical nonsurgical knee joint traction on knee pain, function, and quality of life.

NCT ID: NCT04329897 Completed - Knee Osteoarthritis Clinical Trials

Acceptance and Commitment Therapy Delivered by Automated Software Messaging

Start date: April 5, 2020
Phase: N/A
Study type: Interventional

This study aims to 1) observe the course of pain, 2) mental status, and 3) possible effect of a behavioral intervention delivered via an automated mobile phone messaging robot in patients were indicated and/or scheduled to undergo joint replacement but have been cancelled or delayed due to the COVID-19 crisis.

NCT ID: NCT04324554 Recruiting - Knee Osteoarthritis Clinical Trials

Diagnostic Value of a Biomarker of Non-surgical Knee Osteoarthritis

GENU-PERF
Start date: August 31, 2021
Phase:
Study type: Observational

Osteoarthritis is a very common pathology, especially in an aging population, and a source of disability. Based on standard radiography, the diagnosis is performed late based on the loss of the cartilage thickness. In this context, prosthetic replacement of the joint is a frequent outcome. New diagnostic biomarkers and herapeutic targets are therefore logically research priorities identified by the European League Against Rheumatisms, osteoarthritis ad hoc committee. The inflammation related to the development of this pathology is mainly studied at the cellular level and essentially in animals. Since inflammatory and vascular phenomena are closely intertwined, medical imaging of the subchondral bone vascularization appears interesting. The dynamic contrast-enhanced T1 Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) technique allows the identification of changes in the osteoarthritic subchondral bone vascularization. In osteoarthritic animals, these changes could be identified before the cartilaginous lesions became visible, and could be correlated with the severity of osteoarthritis. This study would be the first to correlate subchondral bone perfusion measurements (performed with the DCE sequence) of early cartilaginous lesions of the knee, identified by non-invasive MRI (T2 mapping) in humans. This examination will be performed on a 3 Tesla MRI. If a correlation is demonstrated in the early stages of osteoarthritis in both humans and animals, then infusion of subchondral bone could become a biomarker of osteoarthritis, and serve as a follow-up evaluation of future treatments.

NCT ID: NCT04323267 Completed - Knee Osteoarthritis Clinical Trials

Digital Home-Exercise Therapy Application For Patients With Non-Surgical Knee Injuries

Start date: January 1, 2020
Phase: N/A
Study type: Interventional

Knee pain is one of the most prevalent musculoskeletal disorders in the United States. Conservative treatments generally consist of pharmacological agents and physical therapy. Unfortunately, such conservative care is often mismanaged, and little data is collected on clinical outcomes. The proposed investigation utilizes a novel and state-of-the-art mobile application (DETP) to guide an at-home exercise therapy program for non-operative knee pain. The purpose of this study is conducting a single-blind randomized, controlled, superiority study to compare the DETP to conventional physical therapy (PT). The investigators will seek to determine improvement in pain and function in PROMIS measures as the primary outcome. The investigators will also evaluate satisfaction with the application as a secondary outcome.

NCT ID: NCT04321668 Completed - Knee Osteoarthritis Clinical Trials

Innovative Tool to Analyse Synovial Fluid of Patients With Knee Ostearthritis After IA Injection of Synvisc-one®

RESYF
Start date: February 12, 2020
Phase: N/A
Study type: Interventional

The objective of this trial is to assess the clinical pertinence of an innovative analytical tool (SYNODIAG) to analyze the Synovial Fluid (SF) composition and guide the patient treatment in a Proof of Concept (PoC) study using OA patients receiving IA injection of SYNVISC ONE®.

NCT ID: NCT04321655 Not yet recruiting - Knee Osteoarthritis Clinical Trials

Reduce Pain and Improve Quality of Life in Patient With Knee Osteoarthritis by Light, Sound and Brain Stimulation

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

Patients affected with osteoarthritis knee have associated with pain and inflammation of the joint capsule, impaired muscular stabilization, decrease range of motion and functional disability. Laser therapy, phonophoresis, transcranial direct current stimulation (tDCS) and conventional physiotherapy exercises has innumerable benefits to the patients with knee osteoarthritis (KOA).However, it is still not clear which treatment is effective among them in rehabilitating the patients with chronic knee osteoarthritis (KOA). Aim is to establish the benefits of High intensity Laser therapy, phonophoresis, tDCS and conventional physiotherapy in the treatment of patient with chronic KOA living in the hilly terrain. A total of 160 patients with chronic KOA will be recruited by the simple random sampling (random number generator) to participate in randomized, double blind randomized controlled, study. Recruited patients with chronic KOA will be randomly divided into four groups, high intensity-laser therapy (HILT) group, ibuprofen gel phonophoresis (IGP) group, transcranial direct current stimulation (tDCS) group and conventional physiotherapy (CPT) group. Duration of the treatment will be 8 minutes in one session/knee joint for HILT and IGP and 30 minutes in one session for tDCS each day for 3 days/week for 8 weeks. Thus, each patient with chronic KOA will receive 24 sessions in total. The Western Ontario and Mc Master Universities Osteoarthritis Index (WOMAC), Digitalized pain pressure algometer (ALGO-DS-01) and 36-Item Short Form Health Survey (SF-36) questionnaire are the outcome measures will be recorded at baseline, end of 8-week post-intervention period.

NCT ID: NCT04321629 Recruiting - Knee Osteoarthritis Clinical Trials

Knee Arthritis Treatment With Autologous Fragmented Adipose Tissue and PRP - Comparison of Two Treatment Methods

Start date: July 30, 2018
Phase: Phase 2
Study type: Interventional

This is a prospective, randomized, controlled study. The purpose of this study is to assess functional and clinical changes among patients with symptomatic knee OA treated with intra-articular injections of autologous adipose tissue or PRP and to compare the efficacy of both therapeutic methods. We hypothesize that adipose tissue injections will improve patients' quality of life and functional status and will decrease pain level significantly more than PRP injections. In addition to the functional tests and muscle strength measurement, the patient reported outcome measures (PROMs) of the knee joint function and quality of life will be used to assess each participant. The same inclusion criteria have been established for an Experimental Group (subjects treated with autologous fat tissue) and a Control Group (subjects treated with PRP). Those criteria consist of: symptomatic knee OA, age between 45 and 65 y.o., Kellgren- Lawrence grades I - III OA, no or minimal positive effects of previous conservative treatment (rehabilitation, hyaluronic acid injections, steroid injections). Those patients who meet inclusion criteria will be allocated to Fat Tissue Group or PRP Group randomly. Patients will be assessed five times: before treatment and 1, 3, 6 and 12 months after the treatment. The PROMs consist of the four questionnaires: The Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee 2000 (IKDC 2000), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (21,22), the Health Questionnaire EQ- 5D- 5L. Moreover, three functional tests will be performed to assess patient's functional status: The Timed Up and Go Test (TUG), The 5 Times Sit to Stand Test (5xSTS), The 10m Walk Test (10mWT). To assess strength parameters of the knee flexors and extensors the Maximal Voluntary Isometric Contraction (MVIC) will be measured. Each test will be supervised by the same one physiotherapist to avoid any interexaminer bias and discrepancies during testing.