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Osteoarthritis, Knee clinical trials

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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: NCT04320875 Not yet recruiting - Knee Osteoarthritis Clinical Trials

Stimulate Brain and Reduce Knee Pain Due to Degeneration

Start date: October 2022
Phase: N/A
Study type: Interventional

Osteoarthritis (OA) knee is chronic, slowly progressive, degenerative disease of joint which affects articular cartilage and accompanied by pain, swelling and loss of function . OA is often considered as the serious joint disease as it has negative impact on quality of life among elderly population, it is the major cause for the reduced mobility. At cental level, due to imbalance in endogenous pain modulation there is reduce capacity of brain to inhibit the pain. Therefore, dysregulation in the central modulation of pain further leads to maladaptive changes in the brain structure. Transcranial direct current stimulation is a non-invasive method to modulate the brain structure by using a week direct current applied through the scalp in painless way. Multi-session for prolonged time can induce neuroplastic changes in the brain. The aim of the study is to demonstrate the effectiveness of tDCS in reducing the pain among patients with chronic knee OA and to modulate the plastic changes in brain structure. A total of 80 patients with KOA will be recruited by the convenience sampling to participate in this two group pretest-posttest, double blinded randomized clinical study. After the demographics, recruited 80 patients with KOA will be randomly divided into two groups, transcranial direct current stimulation (tDCS) group and conventional physiotherapy (CPT) group with by block randomization. Patients with KOA in tDCS group will be provided with Active tDCS and conventional physiotherapy and CPT group will receive structured exercises protocol. Pre-post changes in the outcome measures will be documented at baseline and end of 8-week post intervention. Each session will last for approximately 30 minutes duration.

NCT ID: NCT04276038 Not yet recruiting - Knee Osteoarthritis Clinical Trials

Evaluation of the Efficacy of a Home-Use Photobiomodulation Device for the Treatment of Patients With Knee Osteoarthritis: A Prospective Double Blind, Randomized, Sham-Controlled Clinical Study

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

Osteoarthritis (OA) is a degenerative disease affecting joint cartilage and its surrounding tissue. It is the leading cause of disability in the elderly. The treatment of this disease remains limited to symptomatic relief and, ultimately, joint replacement. Despite the progress made in understanding the pathophysiology of OA, effective disease-modifying drugs are still lacking. Low-level laser therapy (LLLT), also known as Photobiomodulation therapy, is a non-ionizing optical radiation in the visible or near infrared range of the spectrum. LLLI has been used widely for alleviation of pain, reduction of inflammation, and acceleration of wound healing. Specifically, it has been shown to reduce pain in chronic inflammatory related knee pathologies in pre-clinical and clinical studies. However, the recommended treatment protocol requires frequent treatments that translates to frequent visits at the clinic. Such a treatment regimen is difficult for Knee OA (KOA) patients and demanding of the clinical staff. Since the treatment itself can be self-applied easily, a home-use device would enable frequent treatments thereby improving patient adherence to the treatment. In a pilot study, Kruglova et al [4] reported that 2 weeks of daily treatments with the home use B-Cure laser significantly reduced pain and increased flexibility in 20 elite athletes with KOA. The purpose of the current study is to determine if B-Cure laser treatments, applied at home, by the patient or personal caregiver in a real-life situation, can reduce pain and improve functionality in patients with osteoarthritis of the knee.

NCT ID: NCT04257682 Not yet recruiting - Knee Osteoarthritis Clinical Trials

Regional Anesthesia in Total Hip and Knee Arthroplasty

Start date: September 2022
Phase: Phase 4
Study type: Interventional

The purpose of this study is to test whether the use of Ropivacaine and Mepivacaine are better in terms of effectiveness, cost, and safety than Bupivacaine as regional anesthetics in elective hip or knee replacement surgery.

NCT ID: NCT04247893 Not yet recruiting - Clinical trials for Osteoarthritis, Knee

Incorporation of Photobiomodulation Therapy in an Exercise Program With Blood Flow Restriction for Knee Osteoarthritis

Start date: November 2020
Phase: N/A
Study type: Interventional

Knee osteoarthritis (OA) is one of the most common musculoskeletal disorders in the world. The aim of this project is to evaluate the additional effect of photobiomodulation therapy on the quadriceps muscle and knee joint in a blood flow restriction exercise program for individuals with knee OA. To this end, volunteers will be selected at random, aged between 40 and 65 years with pain in one knee, at least in the last 6 months, diagnosed with unilateral knee OA based on the criteria established by the American College of Rheumatology and radiographic confirmation for grades 2 or 3 of the Kellgren-Lawrence Classification, will be randomized into the following groups: (Exercises with blood flow restriction, n = 20), (Exercises with blood flow restriction + photobiomodulation, n = 20) and Exercises with blood flow restriction + placebo photobiomodulation (n = 20). 12 consecutive weeks of treatment will be carried out, with the volunteers being evaluated before and after, using the following instruments: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), sit and stand test, Timed up and Go (TUG), numerical scale pain assessment (END), pain-to-pressure threshold (LDP), skin temperature: quadriceps musculature, knee joint and maximum voluntary isometric contraction (MVIC) of the muscles: quadriceps, middle gluteus. For data analysis, normality test will be used to verify the data distribution and statistical test consistent with the appropriate comparisons within and between groups, thus, two factors are considered in the comparisons, time and group. A significance level of 5% will be adopted.

NCT ID: NCT04234412 Not yet recruiting - Clinical trials for Osteoarthritis, Knee

Treatment of Osteoarthritic Knee With High Tibial Osteotomy and Implantation of Allogenic Human Umbilical Cord Blood-derived Stem Cells.

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

The purpose of this study is to evaluate the clinical results after implantation of human umbilical cord blood-derived mesenchymal stem cells(hUCB-MSCs) and High tibia osteotomy in patients with medial compartment osteoarthritis(MCOA) as well as varus deformity of the knee joint. This study will prospectively evaluate 10 knees after hUCB-MSCs implantation and High Tibial Osteotomy(HTO) in the medial compartment osteoarthritis and varus deformity of the knee joint. Clinical outcomes will be evaluated using the International Knee Documentation committee(IKDC), Visual analogue scale(VAS), Western Ontario and McMaster Universities Arthritis Index(WOMAC), and patients satisfaction with the surgery.

NCT ID: NCT04222140 Not yet recruiting - Clinical trials for Post-Traumatic Osteoarthritis of Knee

Early Regenerative Intervention for Post-Traumatic Osteoarthritis

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

The goal of the proposed research is to compare the ERIPTO protocol for post-traumatic osteoarthritis of the knee with that of bone marrow aspirate concentrate (BMAC) only. The investigators will also conduct a statistical regression analysis looking into factors such as time frame from initial injury, the type of injury, gender, and age when injury first occurred. The investigators plan on evaluating clinically and radiographically the effects of the ERIPTO Protocol. There will be two arms of this study. The first arm will be our protocol arm and the second arm will be our BMAC treatment only arm. The investigators plan on collecting objective data on osteoarthritis (OA) severity by taking plain films and assessing the Kellgren-Lawrence (KL) grading scheme in assessing OA severity. The investigators will also administer MRI evaluations for cartilage and meniscal growth prior to treatment and after 1 year. The investigators also plan on collecting subjective symptom scores in the form of knee injury and osteoarthritis outcomes scores (KOOS), visual analog scores (VAS), and international knee documentation criteria (IKDC) score for OA severity. The investigators plan to track changes in both subjective and objective measures of knee OA in our patients through the course of one year.

NCT ID: NCT04199416 Not yet recruiting - Digital Health Clinical Trials

Effectiveness of a Mobile App for Individuals With or at Risk of Knee Osteoarthritis

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

To develop and examine an interactive, multi-functional mobile app-based technology designed to encourage endogenous health care using a 12-month randomized controlled trial to demonstrate whether knee osteoarthritis (KOA)-at-risk individuals and KOA-diagnosed patients can improve their knee pain, physical function, and other relevant outcomes by using the technology to support knee/KOA self-management.

NCT ID: NCT04190797 Not yet recruiting - Knee Osteoarthritis Clinical Trials

Photobiomodulation on Postoperative Pain

Start date: December 1, 2019
Phase: N/A
Study type: Interventional

Objective: This study is designed to evaluate the short-term efficacy of photobiomodulation for improving pain and function in patients that will undergo total knee replacement and decrease in morphine consumption and adverse effects of opioids. Methods: thirty four patients of both genders that will undergo total knee replacement will participate in this randomized controlled double-blind clinical trial. They will be randomly allocated into two groups: Photobiomodulation group 1 with 18 patients and placebo group with 18 patients and group 3 control without device . Photobiomodulation will be performed twice during 48h, using adivice Light-Aid da BrightPhotomedicine- Brasil, com LED de Arsenieto, Gálio and Alumínio (AsGaAl) of 850 nm device 3B class, measured and calibrated previously .Five points were irradiated on the knee. The placebo group will be treated with the same laser device, but will not be turned on. All patients will receive treatment sessions of photobiomodulation after 24h and 48 h after peripheral nerve blockade (femoral nerve block and nerve supply), applied in 5 points for 5 minutes (300 seconds) close to the incision (that will be protected by transparent film) and repeated every 24h after totaling 2 applications. Patients will be assessed for duration of surgery and anesthesia, assessment of the pain, time to first rescue analgesia request, physical examination, dosimetry of photobiomodulation and amount of morphine consumption using PCA 24h and 48 hours after nerve blockade after surgery. In addition, adverse effects , sedation, paresthesias, motor blockade, nausea and vomiting will be assessed ever 6h during 48h.

NCT ID: NCT04181528 Not yet recruiting - Knee Osteoarthritis Clinical Trials

A Comparison of Anatomically Aligned Versus Conventional in Unilateral Total Knee Arthroplasty

Start date: December 1, 2019
Phase: N/A
Study type: Interventional

Total knee arthroplasty(TKA) is a successful orthopedic surgery with excellent clinical outcome and survival. However, there are concerns about patient satisfaction in previous reports, and dissatisfaction rate of 15-30% is reported in clinical outcomes(PROMs) of some studies. Therefore, for improving the patient's outcome and satisfaction after total knee arthroplasty, it is necessary to change the design of the conventional total knee arthroplsaty implant. The knee is a joint structure with several dynamic functions, and not only the skeletal structure but also the soft tissue balance plays an important role in the function of the knee joint. New implants are being developed to overcome the limitations of conventional TKA implant, including the Journey II Bi-cruciate substituting total knee system (JII-BCS; Smith & Nephew). JII-BCS implant has normal articular geometry, more anatomical femoral shape, lateral tibial convex geometry, and asymmetrical tibial plateau, anterior and posterior cams, which has been shown in experimental studies to produce nearly normal knee movement by reproducing the actual normal anatomical alignment in vivo. The clinical results of the kinematic effects of this anatomcally aligned change are insufficient, and there is also a lack of comparative studies with conventional total knee arthroplasty implant. The purpose of this study is to compare outcomes between anatomically aligned TKA(JII-BCS) and conventional TKA(Legion total knee system, Smith & Nephew). This study is a randomized controlled study in patients undergoing unilateral total knee arthroplasty. A patient will undergo unilateral TKA with anatomically aligned or conventional TKA implant. The implant is determined using a random number table. Radiologic parameter, patients preference and clinical results was investigated in patients who received unilateral TKA during minimum 2 year follow up.