The Efficacy of PRP Combined With Exercise to Treat Knee Osteoarthritisq

Not Applicable

Completed

• Conditions: Physical Exercise; Knee Osteoarthritis; Platelet-rich Plasma
• Interventions: Drug: platelet-rich plasma

• Registration Number: NCT05585216
• Lead Sponsor: Hebei Medical University Third Hospital

Brief Summary

Objective. In this study, the investigators aimed to investigate the efficacy of combined a single platelet-rich plasma (PRP) and physical exercise (leg swing and quadriceps strengthening exercise) versus PRP and hyaluronic acid (HA) combination therapy. Methods. One hundred and six patients with grade Ⅱ-Ⅲ Knee osteoarthritis (KOA) according to the Kellgren-Lawrence classification were randomly divided into intra-articular injection of PRP combined with leg swing and quadriceps strengthening exercise (group A) and intra-articular combination injections of PRP and HA (group B). Patients in group A received twice intra-articular injection of PRP (2 ml, 2 weeks apart) and regular leg swing and quadriceps strengthening exercise for 3 months. Patients in group B received twice intra-articular combination injections of PRP (2 ml) and HA (2 ml) every 2 weeks. The primary outcome measures were Visual Analogue Scale (VAS) and Western Ontario and McMaster Universities (WOMAC) score. The second outcomes included single leg stance test (SLS) and functional activity by 2 minutes walking test (2MWT) and time up and go test (TUGT). All outcomes were evaluated at baseline and after 1,3,6, and 12 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2021-08-31
• Study Completion: 2021-10-01
• Status Verified: 2022-10
• Study First Submitted: 2022-10-15
• Study First Submitted QC: 2022-10-15
• Study First Posted: 2022-10-18
• Last Update Submitted: 2022-10-18
• Last Update Posted: 2022-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• patients aged ≥ 45 years old;
• KOA was diagnosed according to the American College of Rheumatology Classification Criteria;
• patients with the Kellgren-Lawrence grade (K-L grade) for KOA of Ⅰ-Ⅲ;
• a history of symptoms more than three month, and patients with independent mobility.

Exclusion Criteria

• lower limb axial deviation large than 5° (valgus and varus knee);
• patients with diabetes mellitus, sever cardiovascular disease, immunosuppressive status, mental illness or other diseases than might affect the results;
• injections or other invasive treatments into the lower extremities were used in the past three months;
• patients willing to follow the doctor's recommendation for exercise training;
• patients with previous knee fracture or malignancy;
• patients with a previous history of hip or knee joint surgery;
• patients participating in hip or knee muscle strengthening in the past 3 months;
• patients did not complete the intervention strategies or regular follow-up.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRP combined with leg swing and quadriceps strengthening exercise	platelet-rich plasma	Group A received twice intra-articular injection of platelet-rich plasma (2 ml, 2 weeks apart) and regular leg swing and quadriceps strengthening exercise for three months.
intra-articular combination injections of PRP and HA	platelet-rich plasma	Group B received twice intra-articular combination injections of PRP (2 ml) and HA (2 ml) every 2 weeks.

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS)	12 months	Degree of knee pain during treatment
Western Ontario and McMaster Universities (WOMAC) score	12 months	Severity of knee osteoarthritis

Secondary Outcome Measures

Name	Time	Method
single leg stance test (SLS)	12 months	Assess the patient's balance
2 minutes walking test (2MWT)	12 months	Assess the patient's functional activity
time up and go test (TUGT)	12 months	time up and go test (TUGT)

Trial Locations

Locations (1)

the Third Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China