The Efficacy of PRP Combined With Exercise to Treat Knee Osteoarthritisq

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05585216
• Other study ID #: QIE001
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: October 1, 2021

Study information

• Verified date: October 2022
• Source: Hebei Medical University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 1, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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 ?-?;
• 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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Physical Exercise
• Platelet-rich Plasma

Intervention

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

Locations

Country	Name	City	State
China	the Third Hospital of Hebei Medical University	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale (VAS)	Degree of knee pain during treatment	12 months
Primary	Western Ontario and McMaster Universities (WOMAC) score	Severity of knee osteoarthritis	12 months
Secondary	single leg stance test (SLS)	Assess the patient's balance	12 months
Secondary	2 minutes walking test (2MWT)	Assess the patient's functional activity	12 months
Secondary	time up and go test (TUGT)	time up and go test (TUGT)	12 months