The Efficacy of PRP Combined With Exercise to Treat Knee Osteoarthritisq

NCT ID: NCT05585216

Last Updated: 2022-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2021-10-01

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.

Conditions

Platelet-rich Plasma; Physical Exercise; Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

PRP combined with leg swing and quadriceps strengthening exercise

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.

Group Type: EXPERIMENTAL

platelet-rich plasma

Intervention Type: DRUG

intra-articular combination injections of platelet-rich plasma and hyaluronic acid or intra-articular combination injections of PRP combined with leg swing and quadriceps strengthening exercise

intra-articular combination injections of PRP and HA

Group B received twice intra-articular combination injections of PRP (2 ml) and HA (2 ml) every 2 weeks.

Group Type: ACTIVE_COMPARATOR

platelet-rich plasma

Intervention Type: DRUG

intra-articular combination injections of platelet-rich plasma and hyaluronic acid or intra-articular combination injections of PRP combined with leg swing and quadriceps strengthening exercise

Interventions

platelet-rich plasma

intra-articular combination injections of platelet-rich plasma and hyaluronic acid or intra-articular combination injections of PRP combined with leg swing and quadriceps strengthening exercise

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebei Medical University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

the Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Countries

China

Other Identifiers

QIE001

Identifier Type: -

Identifier Source: org_study_id