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Osteoarthritis clinical trials

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NCT ID: NCT05787821 Recruiting - Clinical trials for Rheumatoid Arthritis

Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)

Start date: June 28, 2023
Phase:
Study type: Observational

The main objective of the study is to evaluate the safety, performance and clinical benefits of the Persona implant and its instrumentation in primary total knee arthroplasty

NCT ID: NCT05785884 Recruiting - Knee Osteoarthritis Clinical Trials

Diet Interventions, by Race, Evaluated as Complementary Treatments for Pain

DIRECTPain
Start date: February 1, 2023
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. Non-Hispanic Black individuals (NHB) report greater disability and pain severity compared to Non-Hispanic Whites (NHW). These differences are reinforced through social and biological mechanisms, ultimately resulting in disparities in pain experience and associated quality of life. National efforts to reduce analgesic utilization highlight the critical need for safe, effective, and accessible alternatives for pain relief for underserved/at-risk populations. Low-carbohydrate diets (LCDs) reduce inflammation and pain independent of weight loss, indicating that diet interventions offer a non-pharmacological alternative. However, racial differences exist in metabolism that are rarely addressed in diet intervention studies. Therefore, a LCD may have greater pain-reducing effects in NHBs and provide an alternative treatment for pain. This will be the first study to examine the efficacy of these diets to reduce knee OA pain with an emphasis on race and interactions with biopsychosocial variables. Aim 1: To investigate the efficacy of the LCD to reduce pain and improve QOL. Hypothesis 1: The LCD group will show significantly greater reductions in: self-reported pain and evoked pain when compared to the USDA diet. Hypothesis 2: The LCD group will show greater improvements in: QOL, mood, and self-reported improvement. Hypothesis 3: Both diets will result in improved pain disability, severity, catastrophizing and pain-related fear; the LCD will outperform the USDA diet. Objective 2: To explore racial differences in diet effects and baseline measures. Hypothesis 1: NHBs will show greater improvements in pain, QOL, and mood. Hypothesis 2: NHBs will report greater food insecurity and less proximity to grocery stores. Hypothesis 3: Diet quality will be negatively associated with baseline pain sensitivity. Objective 3: To determine whether physiological variables contribute to diet effects or lack thereof. Hypothesis 1: Baseline physiological measures will predict: pain sensitivity and reductions in pain. NHBs will show greater inflammation at baseline than NHWs. Hypothesis 2: Change in physiological measures will be related to: change in pain, change in QOL, self-reported improvement and mood. NHWs will show greater reductions in inflammation and adiposity than NHBs.

NCT ID: NCT05784545 Recruiting - Knee Osteoarthritis Clinical Trials

Dietary Supplementation With Blueberry in OA

Start date: May 22, 2023
Phase: N/A
Study type: Interventional

Osteoarthritis is a painful long term joint condition that is associated with poor quality of life. There are no treatments to prevent it. Inflammation is one cause of osteoarthritis. This inflammation is complex. It involves many joint tissues, like cartilage and fat. It also involves many proteins that act as inflammatory 'signals'. Safely targeting these proteins with medications has so far proved ineffective. Physiotherapy and weight loss can help osteoarthritis, but there is a need for other approaches. Blueberries are rich in natural chemicals called polyphenols; these have well-established anti-inflammatory effects. Blueberries and other fruits may improve osteoarthritis symptoms, but the investigators do not know how this improvement happens. It may be that these foods reduce inflammation within the joint tissues. They will investigate this. This will help us to understand 1) how blueberries improve osteoarthritis symptoms and 2) whether dietary supplementation with blueberries could slow down joint damage in osteoarthritis, rather than just improving symptoms. Additionally, high levels of joint inflammation predict poorer recovery from joint replacement surgery. Therefore, blueberry supplementation may hasten this recovery. Fifty eight people scheduled to have a knee replacement for osteoarthritis will receive either six weeks blueberry supplementation or a placebo pre-surgery. Participants will continue the supplementation for six weeks after surgery. First, this study will use tissue samples (cartilage, fat and the joint lining called synovium) obtained during surgery to investigate the effects of pre-operative blueberry supplementation on markers of joint inflammation. Second, this study will assess the ability of dietary supplementation with blueberries to improve the symptoms of osteoarthritis. Finally, this study will investigate the effect of blueberry supplementation on recovery from total knee replacement. Our investigations may provide evidence to support dietary supplementation with blueberries to slow down osteoarthritis progression and to improve recovery from osteoarthritis joint replacement surgery.

NCT ID: NCT05783154 Recruiting - Osteoarthritis Knee Clinical Trials

Effect of Mesenchymal Stem Cells in Primary Knee Osteoarthritis

Start date: September 16, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

Osteoarthritis (OA) is the most prevalent chronic joint disorder worldwide and is associated with significant pain and disability. Incidence and prevalence of osteoarthritis rise with increasing age. The prevalence of OA knee in Bangladesh seems to be higher due to poor working conditions, heavy physical labor, and occupational injuries which increase in the future. This will ultimately create a higher clinical and socioeconomic burden on the population and national economy. The course of the disease varies but is often progressive. OA of the knee is one of the common self-reported musculoskeletal pain conditions causing patients to visit the Physical Medicine and Rehabilitation (PM&R) department, at BSMMU. The primary objectives of knee OA treatment focus on pain reduction, and joint mobility improvement, as well as the reduction of disease progression and preserving patients' independence and quality of life. Current treatments aim at alleviating these symptoms by several different methods: Non-pharmacological treatments, Pharmacological treatments, and Invasive interventions. Mesenchymal stem cells (MSCs) therapies for knee osteoarthritis are being investigated in various corners of the world. Both positive and negative findings were observed in that research. Although, the effectiveness of MSCs in KOA is not yet well known. Some studies found MSCs effective, and safe in KOA, and it has the potential to regenerate/heal degraded joint cartilage. MSCs can differentiate into cartilage tissue. Furthermore, MSCs have been shown to have paracrine anti-inflammatory and immunomodulatory effects by producing different growth factors and cytokines. This therapeutics option is under investigation to date. The objective of this trial is to find the effectiveness, safety, and dose difference of adipose tissue-derived stem cells (AT-MSCs) therapy for the treatment of knee osteoarthritis (KOA). But in fact, there is no published data about the effectiveness of autologous adipose tissue-derived mesenchymal stem cells injection on pain, joint functioning, and femoral cartilage thickness in the management of knee osteoarthritis in Bangladesh. Henceforth, this trial will generate new knowledge about the effectiveness, safety, and appropriate dose of AT-MSCs for KOA. So this research will be helpful to generate evidence-based information for an effective treatment option for the management of KOA.

NCT ID: NCT05781230 Completed - Knee Osteoarthritis Clinical Trials

The Effect of Exercises of Different Intensity Applied After Total Knee Arthroplasty on Exercise-Induced Hypoalgesia

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

The aim of this study was to investigate whether exercise-induced hypoalgesia (EIH) is present following exercise in patient after total knee arthroplasty (TKA) and if so, if it changes with exercise intensity. A repeated measures and single-blinded randomized study were done. Thirty-eight patients 24 hours after TKA were randomly assigned to either low intensity exercises (LIE) group or high intensity exercises (HIE) group. An exercise programs lasted for five days during the hospitalization period. Pain severity was assessed by Visual Analog Scale (VAS) (0-10 mm). Pressure pain thresholds (PPTs) were measured over quadriceps and biceps brachii and muscles immediately before and after exercise.

NCT ID: NCT05777564 Completed - Clinical trials for Cardiovascular Diseases

Tolerability of High Intensity Exercise for Knee Osteoarthritis

THIPO
Start date: March 28, 2023
Phase: N/A
Study type: Interventional

Background: Current knee osteoarthritis (OA) guidelines recommend knee specific exercise as treatment for knee OA pain. However, up to 87 % of patients with knee OA have at least one other chronic condition, typically cardiovascular in nature. The elevated risk of cardiovascular health problems can be mitigated by performing aerobic exercise. By consequence, it seems logical to apply aerobic exercise for this patient group as the symptomatic benefit is equal to other types of exercise. Aim: This study aims to assess the tolerability of cardiovascular exercise using High Intensity Interval Training (HIIT) on different self-selected exercise equipment in patients with knee OA and at least one CVD risk factor. Hypothesis: The hypothesis is that performing HIIT exercise is tolerable when having knee OA and at least one CVD risk factor. Method: The study is a prospective cohort study designed to assess if HIIT performed by patients with knee OA and at least one modifiable CVD risk factor influence knee pain. The investigators plan to include 40 participants. The participants will be recruited from the osteoarthritis outpatient clinic at Bispebjerg-Frederiksberg hospital. This study will include participants with a clinical diagnosis of knee OA (either one or both knees) and at least one CVD risk factor (obesity, hypertension, elevated HbA1c (long-term blood glycose), elevated triglycerides, elevated cholesterol (LDL)). All participants will attend the HIIT intervention 3 times per week, for 12 weeks. Before a participant attend their first exercise session, he/she will be asked to complete an educational session about knee OA and aerobic exercise. Participants will have a pre-screening visit (phone call), a screening visit, and a baseline visit, before the 12-week exercise period (3 sessions weekly), and after completion of the exercise period a follow-up visit. Finance: This study is fully funded by Sygesikring "Denmark". Publication: All results, both negative, positive, and inconclusive will be published. Should publication fail, the results will be made publicly available.

NCT ID: NCT05777421 Active, not recruiting - Clinical trials for Knee Osteoarthristis

Efficacy of Virtual Reality Based Exercise Regimes on Kinesiophobia, Pain and Functional Disability in Patients With Knee Osteoarthritis

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

Knee Osteoarthritis is one of the most prevalent degenerative conditions in Pakistan. Although a variety of Physical therapy treatments have been proven to be beneficial in patients with early stages of knee Osteoarthritis. However, a few secondary impairments like Kinesiophobia which is the fear of movement have been unaddressed. Usually after conventional physical therapy, patients find immediate or short-term relief and that leads to cessation of follow up sessions. In situations like these, kinesiophobia is the greatest threat to mobility and can eventually effect quality of life by decreasing functional disability.

NCT ID: NCT05773261 Active, not recruiting - Osteoarthritis, Hip Clinical Trials

Clinical Investigation Comparing Two Different Ultra-porous Coated Surfaces of Uncemented Cups

Start date: September 9, 2022
Phase: N/A
Study type: Interventional

A randomised controlled study comparing two types of ultra-porous coated uncemented cups in total hip arthroplasty. Primary objective is to investigate if the clinical, radiological and patient-reported outcome of the new MobileLINK TabecuLINK cup combined with an X-LINKed insert is non-inferior to the clinical and radiological outcome of the Pinnacle Gription series 100 cup combined with the Marathon liner. Patients are evaluated up to 15 years postoperatively.

NCT ID: NCT05772715 Completed - Clinical trials for Thumb Osteoarthritis

The THumb Osteoarthritis Exercise TriAl

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

Summary: OBJECTIVE(S)/RESEARCH QUESTION(S) Does an orthosis combined with exercise therapy results in less pain and less conversion to surgery than an orthosis alone in patients with first carpometacarpal osteoarthritis (CMC-1 OA), at three months and one year after the start of treatment? HYPOTHESIS We hypothesize that the orthosis + exercise therapy group has less pain and conversion to surgery will be lower than the orthosis group. STUDY DESIGN Randomized controlled multicenter trial STUDY POPULATION(S)/DATASETS Patients with irst carpometacarpal osteoarthritis (CMC-1 OA) seeking treatment INTERVENTION Orthosis + exercise therapy USUAL CARE/COMPARISON Orthosis only OUTCOME MEASURES Primary outcomes: pain and conversion to surgery SAMPLE SIZE CALCULATION/DATA ANALYSIS Two groups of 80 participants; analysis based on repeated measures analysis (for pain) and chi-squared (for conversion to surgery). We initially planned to perform a logistic regression for conversion to surgery but decided prior to data analysis that we will be using Chi-square tests to determine whether there is a between-group difference in the proportion converting to surgery. We will use a repeated measures analysis for pain. COST-EFFECTIVENESS ANALYSIS (CEA)/ BUDGET IMPACT ANALYSIS (BIA) Economic evaluation will be done from societal & healthcare perspectives, according cost-effectiveness analysis (CEA) guidelines. Medical & non-medical costs and consequences (i.e. productivity loss) will be collected and taken into account. Both CEA and cost-utility analysis will be performed, using conversion to surgery and Quality-adjusted life years (QALYs), respectively TIME SCHEDULE Start preparation: December 2019, inclusion: October 2020- December 2022, final report: December 2023

NCT ID: NCT05771948 Recruiting - Knee Osteoarthritis Clinical Trials

Efficacy and Safety of AqueousJoint Intra-Articular Injections in Mild to Moderate Knee Osteoarthritis

Start date: March 16, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to evaluate the Efficacy and Safety of AqueousJoint Intra-Articular Injection in Mild to Moderate Knee Osteoarthritis of AqueousJoint. The main questions it aims to answer are: - To demonstrate superior efficacy of AqueousJoint administered via intra-articular injection versus placebo during the study period. - To evaluate the efficacy of two different concentrations of AqueousJoint, administered via single IA injection as compared to control group (placebo) One IA injection of AqueousJoint or Placebo will be injected to participants' knee. Follow up will take place up to six months.