Participants With Knee Osteoarthrosis
NCT Number: NCT06535425
Acronym: KOA
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Knee Osteoarthrosis
Interventions: OTHER: Platelet-Rich Plasma|OTHER: Isometric Contractions of Quadriceps|OTHER: Platelet-Rich Plasma Combined with Isometric Contractions of Quadriceps|OTHER: Control
Sponsor: Chengdu Sport University
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 82
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-03-05
Completion Date: 2023-12-28
Locations: Chengdu Sport University, Chengdu, Sichuan, 610041, China

Summary:
Title: Efficacy and Safety Trial of PRP and ICQ for Elderly Women with KOA

Goal:

To assess if PRP and ICQ reduce symptoms and improve mobility in elderly women with knee osteoarthritis.

Key Questions:

Does PRP and ICQ decrease symptom severity as measured by WOMAC? What side effects occur from PRP and ICQ intervention?

Participants:

Elderly women, aged 60-70, with KOA.

Intervention:

PRP injection and ICQ exercises for 16 weeks.

Procedure:

Daily PRP or placebo for 4 months. Bi-weekly clinic visits for assessments. Weekly health education and lifestyle monitoring.

Measurements:

WOMAC scores, physical mobility tests, and serum biomarkers before and after intervention.

Ethics:

Approved by Chengdu Sport University\&#39;s Ethics Committee.

Sample Size:

80 participants needed.

Randomization:

Random assignment to PRP, ICQ, or control groups.

This trial aims to determine the benefits and risks of PRP and ICQ in treating KOA in elderly women.

Primary Outcome Measures: KOA Symptom Assessment, Symptoms of KOA participants were evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). These questions included assessments of pain (5 questions), stiffness (2 questions) and physical function (17 questions), totalling 24 questions. A 0-100 mm visual analogue scale was used for scoring, which was measured and recorded by a professional by using a ruler. The scores for pain (maximum 500), stiffness (maximum 200) and physical function (maximum 1700) were based on the measured values, with higher scores indicating greater severity., 16 Weeks|Balance Ability Testing, The static and dynamic balance of all participants was tested using a BioDex Balance System (BioDex Medical Systems, USA). The test session required participants to stand with both feet, with their hands placed on their sides. The static balance tests included firm surface with eyes closed (FiEC), foam surface with eyes open (FoEO) and foam surface with eyes closed (FoEC) tests., 16 Weeks|Isokinetic Muscle Strength Testing of the Knee, The isokinetic strength of both knees (60°/s for 5 repetitions and 180°/s for 5 repetitions) was tested in all participants by using a Germany-manufactured IsoMed 2000 isokinetic testing device. The knee was positioned in a sitting posture with a range of motion of 80°. Participants were required to warm their lower limbs for 10 minutes before the test. The testers provided verbal encouragement throughout the process to ensure reliable test data. The index was the peak torque., 16 Weeks|Knee Proprioception Testing, After completing the isokinetic muscle strength test while maintaining the test posture, proprioceptive testing was conducted on the dominant side. The angular velocity was set at 1°/s. The isokinetic device's actuator automatically moved to preset angles of 30° and 60° of knee flexion (with the fully extended knee position at 0°). After each movement to an angle, the actuator returned to the starting position, the participant actively moved to the designated position (the movement stopped automatically after pressing a button), and the difference between the actual and preset angles was recorded. Smaller differences indicate better proprioception, and the average of three trials for each angle was taken., 16 Weeks|6-minute walk test, Participants walked back and forth on an outdoor closed corridor (50 m) for 6 minutes, allowing them to slow down or rest if necessary but encouraged to continue walking as much as possible. The time was announced every minute, and the participants were informed of the remaining time 15 seconds before the end of 6 minutes. When the time ended, the participants stopped where they were and marked their position. The total distance walked by the participants was measured in meters., 16 Weeks|Time up and go test, Participants sat on a chair with armrests and a backrest (seat height 45 cm, armrest height 20 cm), leaning their backs with their hands on the armrests. A mark was placed 3 meters away from the seat. Upon hearing the 'start' command, participants were required to stand up from the chair, walk forward 3 meters to the mark, turn around and quickly walk back to the chair, then turn and sit down, leaning back against the chair. The time taken from when the participant's back left the chair until they sat down again was recorded in seconds. Participants could practice one or two times before the formal test, which was conducted three times with a 1- to 2-minute interval between each test. The average of the three trials was taken., 16 Weeks|Time up and down stairs, Participants were asked to ascend and descend 12 times as quickly as possible, with each step being 18 cm in height and 30 cm in width. Participants could use the handrails during the process. The time required was recorded in seconds using a stopwatch., 16 Weeks|TNF-α Testing, Fasting venous blood (5 mL) was collected from all participants upon waking in the morning and centrifuged for 5 minutes (at a centrifugation speed of 3500 r/min and a centrifugation radius of 15 cm) to separate the serum, which was then stored at -80 °C until analysis. The expression levels of serum tumour necrosis factor-α (TNF-α)., 16 Weeks|IL-1β Testing, Fasting venous blood (5 mL) was collected from all participants upon waking in the morning and centrifuged for 5 minutes (at a centrifugation speed of 3500 r/min and a centrifugation radius of 15 cm) to separate the serum, which was then stored at -80 °C until analysis. The expression levels of serum interleukin-1β (IL-1β) ., 16 Weeks|MMP-13 Testing, Fasting venous blood (5 mL) was collected from all participants upon waking in the morning and centrifuged for 5 minutes (at a centrifugation speed of 3500 r/min and a centrifugation radius of 15 cm) to separate the serum, which was then stored at -80 °C until analysis. The expression levels of serum matrix metalloproteinases-13., 16 Weeks