Knee Osteoarthritis, Physical Exercise, Platelet-rich Plasma
Conditions
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.
Interventions
DRUGplatelet-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
Sponsors
Hebei Medical University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
China
Outcome results
None listed