The Efficacy of PRP Combined With Exercise to Treat Knee Osteoarthritisq
Primary Purpose
Platelet-rich Plasma, Physical Exercise, Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
platelet-rich plasma
Sponsored by
About this trial
This is an interventional treatment trial for Platelet-rich Plasma
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.
Sites / Locations
- the Third Hospital of Hebei Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PRP combined with leg swing and quadriceps strengthening exercise
intra-articular combination injections of PRP and HA
Arm Description
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 B received twice intra-articular combination injections of PRP (2 ml) and HA (2 ml) every 2 weeks.
Outcomes
Primary Outcome Measures
Visual Analogue Scale (VAS)
Degree of knee pain during treatment
Western Ontario and McMaster Universities (WOMAC) score
Severity of knee osteoarthritis
Secondary Outcome Measures
single leg stance test (SLS)
Assess the patient's balance
2 minutes walking test (2MWT)
Assess the patient's functional activity
time up and go test (TUGT)
time up and go test (TUGT)
Full Information
NCT ID
NCT05585216
First Posted
October 15, 2022
Last Updated
October 18, 2022
Sponsor
Hebei Medical University Third Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05585216
Brief Title
The Efficacy of PRP Combined With Exercise to Treat Knee Osteoarthritisq
Official Title
The Efficacy of PRP Combined With Leg Swing and Quadriceps Strengthening Exercise to Treat Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hebei Medical University Third Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Platelet-rich Plasma, Physical Exercise, Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PRP combined with leg swing and quadriceps strengthening exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
intra-articular combination injections of PRP and HA
Arm Type
Active Comparator
Arm Description
Group B received twice intra-articular combination injections of PRP (2 ml) and HA (2 ml) every 2 weeks.
Intervention Type
Drug
Intervention Name(s)
platelet-rich plasma
Intervention Description
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 Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
Degree of knee pain during treatment
Time Frame
12 months
Title
Western Ontario and McMaster Universities (WOMAC) score
Description
Severity of knee osteoarthritis
Time Frame
12 months
Secondary Outcome Measure Information:
Title
single leg stance test (SLS)
Description
Assess the patient's balance
Time Frame
12 months
Title
2 minutes walking test (2MWT)
Description
Assess the patient's functional activity
Time Frame
12 months
Title
time up and go test (TUGT)
Description
time up and go test (TUGT)
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
the Third Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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The Efficacy of PRP Combined With Exercise to Treat Knee Osteoarthritisq
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