Clinical trial NCT06535425: Participants With Knee Osteoarthrosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthrosis
Keywords: Knee Osteoarthrosis
Platelet-Rich Plasma
Isometric Contractions of Quadriceps
Lead sponsor: Chengdu Sport University
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 82
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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\&#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.

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.

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.

Primary outcomes:
measure: KOA Symptom Assessment
timeFrame: 16 Weeks
measure: Balance Ability Testing
timeFrame: 16 Weeks
measure: Isokinetic Muscle Strength Testing of the Knee
timeFrame: 16 Weeks
measure: Knee Proprioception Testing
timeFrame: 16 Weeks
measure: 6-minute walk test
timeFrame: 16 Weeks
measure: Time up and go test
timeFrame: 16 Weeks
measure: Time up and down stairs
timeFrame: 16 Weeks
measure: TNF-α Testing
timeFrame: 16 Weeks
measure: IL-1β Testing
timeFrame: 16 Weeks
measure: MMP-13 Testing
timeFrame: 16 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Chengdu Sport University
state: Sichuan
Study officials:
affiliation: Chengdu Sport University
name: Yajun Tan, Dr
role: PRINCIPAL_INVESTIGATOR
References: