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Completed

NCT Number: NCT05585216

The Efficacy of PRP Combined With Exercise to Treat Knee Osteoarthritisq

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.

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Key information

Conditions

Platelet-Rich Plasma Arthritis Behavior Joint Diseases Knee Osteoarthritis Motor Activity Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Physical Exercise Rheumatic Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

platelet-rich plasma

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

Primary outcomes

  1. Visual Analogue Scale (VAS)

    Time frame: 12 months

    Degree of knee pain during treatment

  2. Western Ontario and McMaster Universities (WOMAC) score

    Time frame: 12 months

    Severity of knee osteoarthritis

Secondary outcomes

  1. single leg stance test (SLS)

    Time frame: 12 months

    Assess the patient's balance

  2. 2 minutes walking test (2MWT)

    Time frame: 12 months

    Assess the patient's functional activity

  3. time up and go test (TUGT)

    Time frame: 12 months

    time up and go test (TUGT)

Sponsors and collaborators

Lead sponsor

Hebei Medical University Third Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 18, 2022
Registry last updated
Oct 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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