Clinical Trials Logo

Clinical Trial Summary

The main purpose of the study is to examine the effect of squat-based exercise approach in individuals with knee osteoarthritis. The aim of this study is to compare effect to three groups (flywheel exercise group, electrotherapy modality group and home exercise group) and also decrease the pain, increase muscle strength, activation values and increase the functional level of individuals. Osteoarthritis is the most common rheumatological disease in the world that primarily results in progressive cartilage destruction. Changes occurring as a result of osteoarthritis are the main cause of disability and are most common in the knee joint. Osteoarthritis; problems such as pain, tenderness, joint stiffness, joint swelling, movement restriction, joint deformities, loss of muscle strength, decreased functional capacity and impaired quality of life are observed. The daily life activities of individuals with knee osteoarthritis are restricted by the problems of walking up and down stairs, getting out of the chair, standing, squatting, walking. Improving the symptoms of the disease is an important goal of the rehabilitation process of patients with knee osteoarthritis. In individuals with knee osteoarthritis, joint structure and deformation in cartilage also show loss of strength with muscles. Strengthening exercises have been used in patients with knee osteoarthritis for a long time. Squat exercise is a type of exercise that is widely used as a strengthening exercise.


Clinical Trial Description

OA is endemic around the world. About 30.8 million adults in the United States and 300 million people worldwide live with OA. OA is a disease of the entire joint involving structural changes in articular cartilage, subchondral bone, ligaments, capsule, synovial membrane, and periarticular muscles. Clinically, OA is characterized by joint pain, tenderness, limitation of movement, crepitus, effusion and varying degrees of non-systemic inflammation. Pain, stiffness and difficulty in daily life activities due to the negative impact of functional status are among the main symptoms. The knee is the most affected joint. The aim of this study is to compare effect to three groups (flywheel exercise, electrotherapy modality and home exercise) Flywheel training is a strength training modality that offers the possibility of performing exercises with eccentric overload and variable resistance as compared to conventional gravity-based resistance training. Electrophysical agents are used by physiotherapists to treat a wide variety of conditions. Electrotherapy modalities especially transcutaneous electrical nerve stimulation (TENS) and ultrasound is used to treat OA Hypothesis: - Ho: Three different protocols applied in individuals with knee osteoarthritis have no effect. - H1-0: It is effective in three different protocols applied in individuals with knee osteoarthritis, but three don't have statistically effect on each other. - H1-1: Exercise with isoinertial system in individuals with knee osteoarthritis to be more effective than other treatment protocols - H1-2: Electrotherapy (TENS, ultrasound and hot pack or cold pack) and squat-based home exercise program is more effective than other treatment protocols in individuals with knee osteoarthritis. - H1-3: Electrotherapy (TENS, ultrasound and hot pack or cold pack) and squat-based home exercise program in individuals with knee osteoarthritis to be more effective than other treatment protocols Randomization and blinding After the baseline assessment, the participants were randomized to one of three intervention groups (ratio 1:1:1) using "Research Randomizer," an online randomization web service (https://www.randomizer.org/). It was planned as a double-blind study without knowing the necessary treatment or experimental condition for both the subject and the researchers. Sample size Sample size was determined using an Instat sample size calculator. In the WOMAC sections, the smallest detectable difference and minimal clinically important difference ranged from 0.51 to 1.33 points. This value was used to calculate the sample size (Angst, Aeschlimann, and Stucki, 2001). Investigators included a two sided alpha value of 0.05, a power of 0.9, and a sample size of 21 per group. To allow for dropouts, the sample size was set at 25 per group. Risk management: Failure to reach the number of patients, receiving support from other hospitals of the Medipol Hospital Group Unusual increase in the rate of increase of Covid 19 outbreak, (second wave, permanent curfew): Online controlled (tele-rehabilitation) exercises Research center Sefaköy Medipol University Hospital Health Practice and Research Center Statistical method (s) to be used Statistical analysis will be calculated using SPSS for Windows 22 program. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04588558
Study type Interventional
Source Istanbul Medipol University Hospital
Contact
Status Completed
Phase N/A
Start date September 15, 2020
Completion date April 2, 2021

See also
  Status Clinical Trial Phase
Completed NCT05452499 - Pain Neuroscience Education and Therapeutic Exercise as a Treatment for Breast Cancer Survivors Living With Sequelae N/A
Recruiting NCT05037682 - Pain and Opioid Management in Older Adults N/A
Completed NCT04080037 - Assessing Opioid Care Practices Using CPV Patient Simulation Modules N/A
Recruiting NCT05382962 - iCanCope With Post-Operative Pain (iCanCope PostOp) N/A
Recruiting NCT04285112 - SPRINT: Signature for Pain Recovery IN Teens
Active, not recruiting NCT04850079 - EHR Precision Drug Treatment in Neonates
Completed NCT03272139 - Interscalene Block Versus Superior Trunk Block Phase 4
Completed NCT03271151 - Effect of Duloxetine on Opioid Use After Total Knee Arthroplasty Phase 4
Completed NCT03886142 - Platelet Rich Plasma Versus Radio Frequency for Chronic Knee Arthritis N/A
Recruiting NCT05761392 - APP-based Precise Management System of Chronic Intractable Pain N/A
Recruiting NCT05877157 - Pain AND Opioids After Surgery
Completed NCT03947749 - Linking Epigenomics With Prescription Opioid Abuse and High Impact Musculoskeletal Pain
Completed NCT03280017 - Ketamine With Multilevel Paravertebral Block for Post Video-assisted Thoracic Surgery Pain Phase 4
Recruiting NCT04874038 - Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN) Phase 3
Completed NCT04280796 - Changes in Affective Pain Processing in Human Volunteers N/A
Withdrawn NCT05125978 - Efficacy and Safety of Canadá Association in the Treatment of Chronic Pain Phase 2
Not yet recruiting NCT04328805 - Pain Reduction and Changes in Upper Limb Function Produced by an Ibuprofen Treatment in Carpal Tunnel Syndrome. Phase 4
Completed NCT04976738 - A Study of Cybis™ 10:25 THC:CBD Oil in Adults With Chronic Back/Neck Pain Phase 1/Phase 2
Completed NCT04089618 - Meditation Based Lifestyle Modification in Chronic Pain N/A
Recruiting NCT05699837 - Alpha Entrainment for Pain and Sleep (Extension) N/A