Participants With Knee Osteoarthrosis

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 60 to 70 years
• Women only
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

Official title: Effects of Platelet-Rich Plasma Combined With Isometric Contractions of Quadriceps on Symptoms, Postural Control, Mobility and Inflammatory Markers in Participants With Knee Osteoarthrosis

Conditions

Knee Osteoarthrosis

Being tested

Platelet-Rich Plasma, Isometric Contractions of Quadriceps, Platelet-Rich Plasma Combined with Isometric Contractions of Quadriceps, Control

Keywords

Knee Osteoarthrosis, Platelet-Rich Plasma, Isometric Contractions of Quadriceps

Medical subject headings

Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Platelet-Rich PlasmaOther

  The PG and JG were injected with autologous PRP at baseline. The injection was performed by the same clinician with 10 years of experience in knee joint injections. Participants were seated with their knees extended, and the needle was inserted through the joint space into the intra-articular cavity of the knee, administering approximately 2.5 mL of PRP into each knee joint. Thirty millilitres of venous blood were drawn from the participant's elbow vein, and approximately 5 mL of PRP was obtained for bilateral knee joint injection by using a TD5A tabletop low-speed centrifuge manufactured in China. The first centrifugation was performed at 2500 revolutions per minute (rpm) for 3 minutes, followed by a second centrifugation at 2300 rpm for 6 minutes.

• Isometric Contractions of QuadricepsOther

  The IG and JG exercises followed the methods of our previous research, with participants undergoing an 16-week ICQ intervention five times per week. Each session consisted of isometric contractions and relaxations of the quadriceps muscle for 5 seconds each, in sets of 30 repetitions, for a total of 10 sets, with a 30-second rest between sets. During this period, researchers conducted weekly follow-up calls or face-to-face interviews with participants to understand their living conditions, ensuring that they did not change their original lifestyle habits and did not engage in any other form of regular fitness activities. Participants who did not comply were not included in the final data analysis.

• Platelet-Rich Plasma Combined with Isometric Contractions of QuadricepsOther

  Platelet-Rich Plasma Combined with Isometric Contractions of Quadriceps

• ControlOther

  Initially, all participants received identical health education in the form of thematic lectures once per week for 40 minutes each. The content included the following aspects: emphasising the importance of close cooperation with physicians as key to maintaining health; the process of the occurrence and development of KOA, along with its treatment methods; the role of family and social support in improving the condition; establishing a reasonable daily activity routine, such as protecting the affected knee joint, avoiding long-distance fatigue, mountain climbing, ascending and descending high-rise stairs and various adverse body postures (prolonged standing, kneeling and squatting); and advising those who are overweight to reduce their body weight. On this foundation, the four groups of participants underwent the following interventions.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: 16 Weeks

2. 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.

   Measured: 16 Weeks

3. 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.

   Measured: 16 Weeks

4. 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.

   Measured: 16 Weeks

5. 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.

   Measured: 16 Weeks

6. 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.

   Measured: 16 Weeks

7. 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.

   Measured: 16 Weeks

8. 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).

   Measured: 16 Weeks

9. 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) .

   Measured: 16 Weeks

10. 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.

    Measured: 16 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted2 Aug 2024
2. Study start5 Mar 2023
3. Primary completion25 Dec 2023
4. Study completion28 Dec 2023

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Knee OsteoarthrosisStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.