Platelet-rich PlasmaNCT05585216

The Efficacy of PRP Combined With Exercise to Treat Knee Osteoarthritisq

A study testing platelet-rich plasma in people with Platelet-rich Plasma and Physical Exercise, run by Hebei Medical University Third Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Platelet-rich Plasma, Physical Exercise, Knee Osteoarthritis
What is being tested?: platelet-rich plasma
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteChina
Study dates: 1 Jan 2021to 1 Oct 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

the Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000

Other trials in China

About this study

Official title: 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.

Conditions: Platelet-rich Plasma, Physical Exercise, Knee Osteoarthritis
Being tested: platelet-rich plasma
Medical subject headings: Motor Activity, Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

platelet-rich plasmaDrug
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

Study groups in NCT05585216
Study group	Role	What they receive
PRP combined with leg swing and quadriceps strengthening exercise	Experimental	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. Receives: Drug: platelet-rich plasma
intra-articular combination injections of PRP and HA	Active comparator	Group B received twice intra-articular combination injections of PRP (2 ml) and HA (2 ml) every 2 weeks. Receives: Drug: platelet-rich plasma

What is being measured

The primary outcome is the main question the study is designed to answer.

Visual Analogue Scale (VAS)
Degree of knee pain during treatment
Measured: 12 months
Western Ontario and McMaster Universities (WOMAC) score
Severity of knee osteoarthritis
Measured: 12 months

Secondary outcomes (3)

single leg stance test (SLS)
Assess the patient's balance
Measured: 12 months
2 minutes walking test (2MWT)
Assess the patient's functional activity
Measured: 12 months
time up and go test (TUGT)
time up and go test (TUGT)
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20211 Oct 2021

First posted18 Oct 2022
Study start1 Jan 2021
Primary completion31 Aug 2021
Study completion1 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Platelet-rich PlasmaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05585216
Sponsor's protocol ID: QIE001
Status last verified: Oct 2022
First submitted: 15 Oct 2022
Last updated: 20 Oct 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Efficacy of PRP Combined With Leg Swing and Quadriceps Strengthening Exercise to Treat Knee Osteoarthritis
ClinicalTrials.gov ID: NCT05585216
Acronym / sponsor ID: QIE001
Conditions: Platelet-rich Plasma, Physical Exercise, Knee Osteoarthritis
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Hebei Medical University Third HospitalUniversity, hospital or other
Study start: 1 Jan 2021 (actual)
Primary completion: 31 Aug 2021 (actual)
Study completion: 1 Oct 2021 (actual)
First posted: 18 Oct 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
PRP combined with leg swing and quadriceps strengthening exercise	Experimental	Drug: platelet-rich plasmaGroup 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.
intra-articular combination injections of PRP and HA	Active comparator	Drug: platelet-rich plasmaGroup B received twice intra-articular combination injections of PRP (2 ml) and HA (2 ml) every 2 weeks.

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (8 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
platelet-rich plasmaintra-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	Drug	PRP combined with leg swing and quadriceps strengthening exercise, intra-articular combination injections of PRP and HA

Primary outcome

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

3 secondary outcomes

single leg stance test (SLS)
Time frame: 12 months
2 minutes walking test (2MWT)
Time frame: 12 months
time up and go test (TUGT)
Time frame: 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing platelet-rich plasma in people with Platelet-rich Plasma and Physical Exercise, run by Hebei Medical University Third Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analogue Scale (VAS) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05585216.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2022.