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

Study Overview

• Status: Completed
• Conditions: Early Knee Osseous Arthrophlogosis
• Intervention / Treatment: Other: PRP joint injection combined with acupoint injection

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS) score	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)	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	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

• Sponsor: Zhengzhou Revo-Gene Technology Co., LTD

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2023
• Primary Completion (Actual): April 10, 2023
• Study Completion (Actual): April 10, 2023

Study Registration Dates

• First Submitted: November 9, 2024
• First Submitted That Met QC Criteria: November 12, 2024
• First Posted (Estimated): November 14, 2024

Study Record Updates

• Last Update Posted (Estimated): November 14, 2024
• Last Update Submitted That Met QC Criteria: November 12, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID 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