Participants With Knee Osteoarthrosis

NCT ID: NCT06535425

Last Updated: 2024-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-05
• Study Completion Date: 2023-12-28

Brief 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'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.

Detailed Description

Clinical Trial on the Efficacy and Safety of Platelet-Rich Plasma (PRP) and Isometric Contraction Quadriceps (ICQ) Intervention in Elderly Female Patients with Knee Osteoarthritis (KOA)

Objective:

The primary objective of this clinical trial is to evaluate the effectiveness and safety of Platelet-Rich Plasma (PRP) combined with Isometric Contraction Quadriceps (ICQ) intervention in treating knee osteoarthritis in elderly female patients. The study aims to answer the following questions:

Does the combination of PRP and ICQ reduce the severity of KOA symptoms as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)? What are the potential side effects or complications associated with the PRP and ICQ intervention in elderly patients?

Study Design:

The trial will be a randomized controlled trial comparing the effects of PRP and ICQ intervention with those of a control group. Participants will be randomly assigned to one of four groups: PRP group, ICQ group, joint group (receiving both PRP and ICQ), or control group.

Participants:

Elderly female patients diagnosed with KOA, aged between 60 and 70 years, will be recruited from the Sichuan Provincial People's Hospital. The inclusion and exclusion criteria will be strictly followed to ensure the homogeneity and reliability of the study population.

Intervention:

Participants in the PRP and joint groups will receive an injection of autologous PRP at baseline. The PRP will be prepared from venous blood using a low-speed centrifuge. Participants in the ICQ and joint groups will undergo a 16-week ICQ intervention, performing isometric contractions and relaxations of the quadriceps muscle five times per week.

Procedure:

Participants will receive either PRP injection or a placebo (for the control group) at baseline.

They will undergo a 16-week ICQ intervention if assigned to the ICQ or joint group.

Participants will be required to attend weekly health education sessions for the first month.

They will be followed up weekly through calls or interviews to monitor their adherence to the intervention and to ensure they maintain their usual lifestyle habits.

Assessment:

KOA symptoms will be evaluated using the WOMAC index at baseline and at the end of the 16th week.

Physical mobility will be assessed using the 6-minute walk test (6MWT), time up and go test (TUG), and time up and down stairs (TUDS) at baseline and at the end of the intervention.

Serum levels of inflammation markers and matrix metalloproteinases-13 (MMP-13) will be measured at baseline and post-intervention.

Outcome Measures:

Primary outcomes will include changes in WOMAC scores and physical mobility tests.

Secondary outcomes will include serum levels of TNF-α, IL-1β, and MMP-13.

Ethical Considerations:

The study is approved by the Human Ethics Committee of Chengdu Sport University, and informed consent will be obtained from all participants. The study will adhere to the Declaration of Helsinki.

Sample Size Calculation:

Based on a 4 (group) × 3 (measurement occasions) design, with an estimated dropout rate of approximately 15%, an effect size of 0.3, a power of 0.8, and a significance level of 0.05, a minimum sample size of 80 participants is determined to be necessary.

Randomization:

A total of 92 participants will be recruited and randomly assigned to the four groups using a digital randomization method.

Data Analysis:

Data will be analyzed using appropriate statistical methods to compare the outcomes between the intervention and control groups, as well as among the different intervention groups.

This clinical trial aims to provide evidence-based insights into the efficacy and safety of PRP and ICQ interventions in managing KOA in elderly female patients.

Conditions

Knee Osteoarthrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

Initial Health Education for Participants 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.

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: OTHER

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.

Platelet-Rich Plasma

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.

Group Type: EXPERIMENTAL

Platelet-Rich Plasma

Intervention Type: OTHER

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.

Control

Intervention Type: OTHER

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.

Isometric Contractions of Quadriceps

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.

Group Type: EXPERIMENTAL

Isometric Contractions of Quadriceps

Intervention Type: OTHER

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.

Control

Intervention Type: OTHER

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.

Platelet-Rich Plasma Combined with Isometric Contractions of Quadriceps

Platelet-Rich Plasma Combined with Isometric Contractions of Quadriceps

Group Type: EXPERIMENTAL

Platelet-Rich Plasma

Intervention Type: OTHER

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 Quadriceps

Intervention Type: OTHER

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 Quadriceps

Intervention Type: OTHER

Platelet-Rich Plasma Combined with Isometric Contractions of Quadriceps

Control

Intervention Type: OTHER

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.

Interventions

Platelet-Rich Plasma

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.

Intervention Type: OTHER

Isometric Contractions of Quadriceps

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.

Intervention Type: OTHER

Platelet-Rich Plasma Combined with Isometric Contractions of Quadriceps

Platelet-Rich Plasma Combined with Isometric Contractions of Quadriceps

Intervention Type: OTHER

Control

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Female aged between 60 and 70 years
• Participants with KOA severity grades I, II and III were selected
• the study complied with the Declaration of Helsinki, and informed consent was obtained from all participants

Exclusion Criteria

• Need for surgery or pharmacological treatment in the near future
• The presence of neuromuscular diseases and participation in other regular exercise programmes.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Chengdu Sport University

OTHER

Sponsor Role: lead

Responsible Party

Cheng Liang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yajun Tan, Dr

Role: PRINCIPAL_INVESTIGATOR

Chengdu Sport University

Locations

Chengdu Sport University

Chengdu, Sichuan, China

Countries

China

Other Identifiers

2024NSFSC0681

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

[2022]14

Identifier Type: -

Identifier Source: org_study_id