Comparison of the Effects of Different Treatment Modalities on Pain, Quality of Life, and Musculoskeletal System in Individuals with Knee Osteoarthritis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hacettepe University
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Tibiofemoral angle measurement
Study Overview
Brief Summary
Knee osteoarthritis (gonarthrosis) is one of the most common types of osteoarthritis. It is a degenerative joint disorder characterized by pain, muscle weakness, and functional loss. There have been no studies comparing the effects of conservative treatment approaches such as virtual reality exercises, orthoses, and kinesio taping. Therefore, the aim of this current study is to compare the effectiveness of virtual reality exercises alone and in combination with orthotic approach and kinesio taping in individuals with knee osteoarthritis. The participants included in the study will be randomly divided into three groups. The first group will receive virtual reality exercises, the second group will receive virtual reality exercises along with valgus orthosis, and the third group will receive virtual reality exercises combined with kinesio taping treatment. The interventions will be applied three times a week for eight weeks. Evaluations will be repeated before and after the exercise therapy. The evaluations will include pain assessment using the Visual Analog Scale (VAS), muscle strength measured by hand dynamometer, balance assessed by the Berg Balance Scale, proprioception measured by stabilizer and inclinometer, joint range of motion measured by goniometer, functional status evaluated by the WOMAC scale, lower extremity length measured by tape measure, walking speed assessed by the 10-Meter Walk Test (10 MWT), quality of life measured by the SF-36 questionnaire, kinesiophobia evaluated by the Tampa Scale for Kinesiophobia, architectural features of the quadriceps femoris muscle assessed by ultrasound imaging, knee OA score measured by the Knee Injury and Osteoarthritis Outcome Score (KOOS), and medial compartment distance of the knee calculated and recorded using computer-aided analysis on anteroposterior radiographs.
Detailed Description
The patients to be evaluated in this study are those who were diagnosed with gonarthrosis and met the inclusion criteria. The study will be conducted with volunteer patients who accepted the voluntary consent form.
After the power analysis made in our research, at least 20 individuals in each group with 80% power and 0.05 margin of error.
It was found that a total of 60 individuals were required to participate. Demographic and clinical data of the patients to be included in the study will be obtained.
The patients will be randomized with the help of a computer program (www.randomizer.org) and divided into 3 groups. It will be formed by the patient group who received the Group-I Virtual Reality Exercises training. In addition to Group-II Virtual Reality Exercises training, it will be created by patients using valgus orthosis. Group-III will be formed by patients who receive kinesio taping treatments in addition to virtual reality exercises training. Virtual reality exercises will be applied with the help of Wii-Fit Balance Board (Nintendo of America Inc, Redmond, WA).
Virtual reality exercises are planned 3 times a week for 8 weeks, each session approximately 20-30 minutes and each game 3 repetitions. Balance games and yoga postures within the equipment will be used. "Ski Slalom and Table Tilt" are balance games, "Tree" and "Chair" are yoga posture poses.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Individuals between the ages of 40-65,
- •Those diagnosed with medial compartment knee OA, grade 2-3 according to the Kellgren-Lawrence classification,
- •Patients who can stand on one leg for at least 30 seconds
Exclusion Criteria
- •Presence of neurological problems,
- •Operation in the lower extremities or spinal column,
- •Severe vision, speech, hearing problems,
- •Inability to walk independently,
- •Having a BMI of more than 35,
- •Receiving physical therapy and rehabilitation due to gonarthrosis in the last year.
Arms & Interventions
Virtual Reality Exercises
Virtual Reality Exercises will be applied
Intervention: Virtual Reality Exercises (Other)
Virtual Reality Exercises and Kinesiotaping
Virtual Reality Exercises and Kinesio taping for quadriceps and hamstring muscles will be applied
Intervention: Virtual Reality Exercises and Kinesiotaping (Other)
Virtual Reality Exercises and Valgus Orthoses
Virtual Reality Exercises and Valgus Orthoses will be applied.
Intervention: Virtual Reality Exercises and Valgus Orthoses (Other)
Outcomes
Primary Outcomes
Tibiofemoral angle measurement
Time Frame: 2 months
It is calculated by AP X-ray taken while the patient is in the standing position. It is found by the angle between the anatomical axis of the femur and the anatomical axis of the tibia. Its normal value is between 2.2 and 7.4. This angle is affected by all angle-related values of the lower extremity. Therefore, it is highly correlated with functional capacity. An angle above the normal value indicates valgus, and a decrease below the normal value indicates varus deformity in the lower extremity.
Knee medial compartment distance
Time Frame: 2 months
The minimum width remaining medially between the tibia and the femur will be recorded in millimeters. The minimum joint space width will be measured as the distance between the bones in the medial tibiofemoral region. The minimum distance is between the distal femur and the proximal tibia. The point where the convex line of the medial condyle of the femur is lowest is marked. From this point, the place where the perpendicular drawn on the ground intersects with the tibial plateau is marked. The medial compartment distance of the knee is calculated by recording the distance in millimeters between these two marked points. The decrease in the distance can be interpreted as an increase in the varus deformity of the knee.
Muscle Architectural Evaluation with USG
Time Frame: 2 months
Before and after the treatment, pennation angle calculation and muscle thickness measurement will be made at the 4 heads of the Quadriceps Femoris muscle (vastus medialis, lateralis, intermedius and rectus femoris). These measurements will be evaluated from the middle of the thigh (between the trochanter major of the femur and the midpoint of the lateral condyle of the femur) while the patient is lying in the supine position. Muscle thickness will be measured as the distance between the superficial and deep aponeuroses by applying the vertical and maximum pressure of the USG probe. Pennation angle measurement will be determined by placing the USG probe longitudinally from the middle of the thigh and measuring the angles where the muscle fascicles attach to the deep aponeurosis.
Secondary Outcomes
No secondary outcomes reported
Investigators
Fatih Erbahceci
Prof. Dr. / Principal Investigator
Hacettepe University