The Efficacy of PRP Combined With Exercise to Treat Knee Osteoarthritisq

The Efficacy of PRP Combined With Leg Swing and Quadriceps Strengthening Exercise to Treat Knee Osteoarthritis

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis; Physical Exercise; Platelet-rich Plasma
• Intervention / Treatment: Drug: platelet-rich plasma

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • The Third Hospital of Hebei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: 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
ACTIVE_COMPARATOR: 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.	Drug: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hebei Medical University Third Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2021
• Primary Completion (ACTUAL): August 31, 2021
• Study Completion (ACTUAL): October 1, 2021

Study Registration Dates

• First Submitted: October 15, 2022
• First Submitted That Met QC Criteria: October 15, 2022
• First Posted (ACTUAL): October 18, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 20, 2022
• Last Update Submitted That Met QC Criteria: October 18, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: QIE001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No