Effect of PRP Joint Cavity Combined with Acupoint Injection on Osteoarthritis of Knee Joint

November 12, 2024 updated by: Zhengzhou Revo-Gene Technology Co., LTD
This study collected general data from 90 patients with KOA in the outpatients and ward of Henan Provincial People's Hospital from January 2023 to December 2023 to compare the long-term effects of intra-articular PRP combined with acupoint PRP, intra-articular PRP, and intra-articular HA on symptoms in patients with mild to moderate osteoarthritis

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450000
        • No.7, Wei Wu Road, Zhengzhou City

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. The expected survival period is more than 3 months;
  2. The clinical diagnosis was early knee osteoarthritis;
  3. Capable of knee injections;
  4. chronic joint pain or swelling (> 4 months);
  5. It meets the diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Osteoarthritis (2021 Edition) , and the X-ray evaluation results meet the Kellgren-Lawrence scale (K-L scale) level I to level III.

Exclusion Criteria:

  1. age over 80 years old;
  2. K-L classification is greater than Ⅲ grade;
  3. Combined with rheumatoid arthritis, severe osteoporosis, tumor, gout, obvious joint deformity and other diseases;
  4. Poor compliance, not according to the provisions of treatment;
  5. Pregnant and lactating women;
  6. Patients voluntarily withdrew from the study;
  7. Patients were lost to follow-up due to various reasons during follow-up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: HA group
treated with intra-articular injection of hyaluronic acid solution, 2 ml per injection, and 1 ml of normal saline injection at Xuehai, Yanglingquan, and Weizhong acupoints at the same time, once a week for 4 weeks
Placebo Comparator: PRP joint injection group
treated with intra-articular injection of PRP, 3.5 ml per injection, and 1 ml of normal saline injection at Xuehai, Yanglingquan, and Weizhong acupoints at the same time, once a week for 4 weeks
Other: PRP joint injection combined with acupoint injection
PRP acupoint injection
Experimental: PRP joint injection combined with acupoint injection group
treated with intra-articular injection of PRP, 3.5 ml per injection, and 1 ml of PRP injection at Xuehai, Yanglingquan, and Weizhong acupoints at the same time, once a week for 4 weeks
Other: PRP joint injection combined with acupoint injection
PRP acupoint injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS) score
Time Frame: Assessments will be conducted at weeks 1, 3, 6, and 12 after treatment.
Visual Analog Scale (VAS) score ranging from 1 to 10, with lower scores indicating less pain intensity
Assessments will be conducted at weeks 1, 3, 6, and 12 after treatment.
Knee Society Score (KSS)
Time Frame: Assessments will be conducted at weeks 1, 3, 6, and 12 after treatment.
Knee Society Score (KSS), which consists of five major items totaling 200 points. Higher scores indicate better knee joint function
Assessments will be conducted at weeks 1, 3, 6, and 12 after treatment.
Western Ontario and McMaster Universities Osteoarthritis Index
Time Frame: Assessments will be conducted at 1, 3, 6, and 12 months after treatment.
The severity of knee osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, consisting of 24 items with a total possible score of 240 points. Lower WOMAC scores indicate less severe knee osteoarthritis.
Assessments will be conducted at 1, 3, 6, and 12 months after treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhengzhou Revo-Gene Technology Co., LTD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 10, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 10, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 10, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RG2301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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