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OpenTrials
Completed

NCT Number: NCT06688682

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

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

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Key information

Conditions

Early Knee Osseous Arthrophlogosis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

No.7, Wei Wu Road, Zhengzhou City

Zhengzhou, Henan, 450000, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The expected survival period is more than 3 months;
  • The clinical diagnosis was early knee osteoarthritis;
  • Capable of knee injections;
  • chronic joint pain or swelling (> 4 months);
  • 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

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

Treatment and study plan

PRP joint injection combined with acupoint injection

Other

PRP acupoint injection

Primary outcomes

  1. 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

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

Zhengzhou Revo-Gene Technology Co., LTD

Network

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 14, 2024
Registry last updated
Nov 14, 2024

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.