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Osteoarthritis, Knee clinical trials

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NCT ID: NCT05518097 Completed - Clinical trials for Osteoarthritis, Knee

Effects of Central Sensitization on Response to Conventional Physical Therapy in Patients With Knee Osteoarthritis

Start date: June 3, 2019
Phase:
Study type: Observational

The aim of this study was to investigate the relationship between central sensitization (CS) and poor response to conventional physical therapy in patients with knee osteoarthritis (OA) by evaluating clinical parameters of pain and functionality. 84 knee OA patients with knee pain for at least 3 months and 30 healthy controls were included in the study. Socio-demographic features of the participants such as age, sex, body mass index (BMI), and duration of symptoms were recorded. Structural damage was assessed by knee radiography. Knee pain and functional status were evaluated by visual analogue scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at baseline and immediately after the treatment. Additionally, the following measures were applied at baseline: Central Sensitization Inventory (CSI), Beck Depression Inventory (BDI), Insomnia Severity Index (ISI), Pain Catastrophization Scale (PCS), and PainDETECT Questionnaire (PD-Q). Pressure pain threshold (PPT) was measured with a digital algometer at the painful joint, near the joint area, and in a painless remote region. Patients with knee OA underwent a total of 15 sessions of conventional physical therapy program including hotpack, ultrasound (US), transcutaneous electrical nerve stimulation (TENS), and exercise 5 days a week, for 3 weeks. The control group had no treatment except for the PPT measurement to obtain the reference PPT values. After the treatment, the patients were divided into two groups as 'responders' and 'non-responders' according to their response to treatment. The relationship between the response to physical therapy and clinical parameters was evaluated.

NCT ID: NCT05517434 Not yet recruiting - Clinical trials for Osteoarthritis, Knee

Autologous BMA vs Saline and LAM + LP-PRP vs Saline Evaluations in Knee OA

ABLE-OA
Start date: June 2024
Phase: Phase 2/Phase 3
Study type: Interventional

ABLE OA is a Health Canada authorized (phase II/III) trial [Parent Control #: 263591]. A multi-center, prospective, double-blinded, randomized, placebo-controlled adaptive trial to evaluate the efficacy of two minimally manipulated autologous cellular preparations i) bone marrow aspirate (BMA) injection; and, ii) combined lipoaspirate micronized (LAM) and leukocyte poor (LP) platelet-rich plasma (PRP) injections for the treatment of knee osteoarthritis (OA). BMA, LAM from lipoaspirate (LA), and LP-PRP from whole blood will be prepared using the Cervos Marrow Cellution™ Bone Marrow Aspiration System, Cervos LIPO-PRO™ Adipose Transfer System, and Cervos KEYPRP Platelet Separator System, respectively. Patient-reported outcome measures will be collected using web- or paper-based questionnaires administered at baseline (pre-injection) as well as at 3, 6 and 12 months (post-injection). Blood, synovial fluid, and urine samples will be collected at baseline pre-injection and 6 months post-injection only.

NCT ID: NCT05514704 Not yet recruiting - Clinical trials for Osteoarthritis, Knee

Effects of Different Telerehabilitation Methods on Pain, Functional Limitation, Muscle Strength, Balance, and Quality of Life in Patients With Knee Osteoarthritis.

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

The aim of our study is; To compare the effectiveness of asynchronous and synchronous telerehabilitation programs on pain, functional limitation, muscle strength, balance and quality of life parameters in patients with knee osteoarthritis. 60 patients with knee osteoarthritis who applied to Marmara University Faculty of Health Sciences Physiotherapy and Rehabilitation Department will be included in our study. The treatment and evaluations to be made will be explained and their consent will be obtained with their signatures. Patients will be randomly assigned to the asynchronous telerehabilitation group (n= 30 patients) and the synchronous telerehabilitation group (n= 30 patients). In the asynchronous telerehabilitation group, the rehabilitation program will be carried out via a mobile application (Diabetex). The coordinator will forward the exercise programs prepared specifically for the patients to the relevant participants through the application. On the other hand, telerehabilitation in the synchronous group will be carried out via video conference (Zoom). Patients will be taken to video conference calls and will perform their exercises simultaneously under the guidance of the researcher. An exercise program including lower extremity strengthening and stretching exercises will be applied to all patients. In both groups, the exercise program will be applied 3 days a week for 8 weeks, 1 session per day and 45 minutes per session. All outcome parameters will be evaluated by a blinded assessor who has not seen patients before. Patients starting the rehabilitation program will be evaluated at the beginning of the study, at weeks 4, 8, and 16. The information of the patients participating in the study will be taken with the demographic data form. Pain in patients will be measured with the Visual Analog Scale, while the functionality of the patients will be evaluated with the WOMAC osteoarthritis index and the Lysholm Knee Scoring Scale. In addition, the affected quality of life of the patients will be evaluated with the Patient Generated Index and Short Form-12 scales. While the functional mobility of the patients was evaluated with the Timed Up and Go Test; functional capacities 2 Minute Walk Test, and lower extremity neuromuscular function levels 30 sec. It will be evaluated with Sit and Stand and 5 Sit and Stand performance tests. In addition, the Unilateral Posture Test, Limits of Stability Test, Sit and Stand Up Test will be performed using the NeuroCom Balance Master Posturography device for balance evaluation, and knee flexion and extension muscle strength and proprioception will be evaluated with the Isokinetic device.

NCT ID: NCT05512507 Not yet recruiting - Knee Osteoarthritis Clinical Trials

Sanomechanics® Rehabilitative Technology

Start date: January 30, 2023
Phase:
Study type: Observational

Rehabilitative Sanomechanics Method (RSM) of exercise designed to restore normal subperiosteal transmission of in-joint pressures and normalizing contact pressures on cartilages, will reduce pain in the affected joints and improve locomotor function.

NCT ID: NCT05510648 Not yet recruiting - Knee Osteoarthritis Clinical Trials

Evaluation of the Effect of High-intensity Laser Therapy in Knee Osteoarthritis

Start date: September 25, 2022
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the effects of high intensity laser therapy (HILT) on range of motion, pain, quality of life, muscle strength and femoral cartilage thickness in patients with knee osteoarthritis.

NCT ID: NCT05509972 Recruiting - Knee Osteoarthritis Clinical Trials

In-vivo Wear Behaviour of AS Coated Versus Uncoated Columbus® Total Knee Prosthesis

COLRAS
Start date: April 6, 2023
Phase:
Study type: Observational

This clinical study is a Post-Market Clinical Follow-Up (PMCF) measure and is aiming to compare the in-vivo wear behaviour of the Columbus® total knee prosthesis between the standard Cobalt Chromium (CoCr) and the multilayer coated so called "Advanced Surface" (AS) of the same implant. The clinical investigation is designed as a International, prospective, longterm non-interventional study in order to gain clinical data of many patients within the routine clinical application of the investigational device.

NCT ID: NCT05507619 Not yet recruiting - Clinical trials for Osteoarthritis, Knee

Heat and Acupuncture Randomised Controlled Trial to Manage Osteoarthritis of the Knee

HARMOKnee
Start date: August 17, 2022
Phase: N/A
Study type: Interventional

Knee osteoarthritis (KOA) is one of the largest and fast-growing causes of pain, impaired mobility, and poor quality of life in the elderly worldwide. Despite a significant increase in Traditional Chinese Medicine (TCM) utilisation, in particular acupuncture, as first or second-line treatment among local KOA patients, there exists a lack of high-quality evidence on its efficacy and local practice guidelines for TCM use in KOA tailored to our specific population demographic. HarmoKNEE trial aims to address these gaps by evaluating the short and medium-term clinical and cost-effectiveness of TCM acupuncture with far-infrared heat therapy in addition to standard care, compared to standard care alone. Through a robust process and economic evaluation, the investigators aim to inform evidence-based practice for KOA patients in Singapore to facilitate the large-scale implementation of a comprehensive and holistic model of care which harmonises elements from Western medicine and TCM. The investigators hypothesize that acupuncture with heat therapy as an adjunct to standard care is clinically more effective than standard care alone. This will be a multi-centre pragmatic, parallel-arm, single-blinded, effectiveness-implementation hybrid randomised control trial. KOA patients will be randomised to either the control arm (standard care only) or intervention arm (biweekly sessions of acupuncture with heat therapy over 6 weeks, in addition to standard care). A mixed-method approach through an embedded process evaluation will facilitate large scale implementation. An economic evaluation will be performed to evaluate financial sustainability

NCT ID: NCT05505552 Recruiting - Clinical trials for Osteo Arthritis Knee

Effects of Vitamin K on Lower-extremity Function in Adults With Osteoarthritis:

Start date: September 20, 2023
Phase: N/A
Study type: Interventional

The overall goal of this pilot randomized trial is to obtain necessary prerequisite data to conduct a randomized controlled intervention to test the effect of vitamin K supplementation on knee osteoarthritis progression and related functional decline. To address critical parameters required to design this larger RCT, we will conduct a double-blind, 2-armed, parallel-group intervention study, with a placebo run-in, in which 50 adults with mild to moderate knee OA and low baseline vitamin K status will be randomly assigned to 1 mg phylloquinone/day or matching placebo, and treated for 6 months. Specifically, we will: (1) compare the effects of 1 mg/day phylloquinone vs. placebo on the non-functional circulating form of MGP; (2) estimate rates of recruitment and retention, follow-up rates and reasons for loss to follow-up, response rates to questionnaires, adherence/compliance rates, and potential for site differences; and (3) determine the responsiveness of the Osteoarthritis Research Society International (OARSI)-recommended performance-based tests of physical function in adults with low vitamin K status and mild to moderate knee osteoarthritis. We will also obtain preliminary data on the distribution of MGP genotype at two clinical sites for effect size generation.

NCT ID: NCT05504785 Terminated - Type 2 Diabetes Clinical Trials

DexCom Hospital Study-CGM Directed Insulin Delivery

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

This is a pilot investigator initiated/sponsored clinical trial to evaluate the feasibility of using real-time DexCom G6 continuous glucose monitor (CGM or glucose sensor) trend data and an insulin-dosing algorithm to control the glucose levels of type 2 diabetic patients undergoing hip/knee orthopedic surgery at Thomas Jefferson University Hospital (TJUH). Blinded CGM glucose data will be recorded prior to hospital admission, during hospital admission, and after hospital discharge to evaluate glucose control in this diabetic patient population in relationship to clinical outcomes (20 days of recorded blinded CGM data maximum). Prior studies have associated hyperglycemia, hypoglycemia, and glycemic variability with an increased incidence of nosocomial infection, deep vein thrombosis, pulmonary embolism, cardiac arrhythmias, mental status changes, hospital length of stay, and cost. The 20 type 2 diabetic patients in the Control Group will be managed according to standard-of-care methods at TJUH using finger-stick blood glucose measurements in an attempt to maintain the patient's blood glucose levels in the desired target range (80 to 180 mg/dL). Three blinded CGM will be used to record the patient's glucose trend data for future download to a computer and analysis. The 40 type 2 diabetic patients in the Investigational Group will be managed by the orthopedic floor nurses using the real-time DexCom G6 CGM trend data to determine the appropriate therapy to maintain the patient's glucose levels in the desired target range (80 to 180 mg/dL). In addition, three blinded CGM will be used to record the patient's glucose trend data for future download to a computer and analysis. The primary objective of this pilot study is to observe the blood glucose values and glucose sensor (CGM) values of diabetic patients before, during and after hospitalization for hip and knee arthroplasty surgery to determine whether there is a correlation between glucose control and clinical outcomes. This pilot data will be used to plan a future clinical trial in orthopedic surgery patients using CGM to determine patterns of hyperglycemia, hypoglycemia, and glycemic variability that correlate with clinical complications, hospital length of stay, and cost.

NCT ID: NCT05495334 Recruiting - Knee Osteoarthritis Clinical Trials

Innovations in Genicular Outcomes Registry

iGOR
Start date: September 23, 2021
Phase:
Study type: Observational [Patient Registry]

The registry will capture prospective data on patients receiving pain management for chronic pain due to knee osteoarthritis (OA) or pain optimization for knee arthroplasty due to knee OA. The OA pain therapies may include cryo nerve block, radiofrequency ablation (RFA), intra-articular (IA) corticosteroids, viscosupplementation, opioids, and others (e.g., non-steroidal anti-inflammatory drugs [NSAIDs]).