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

NCT ID: NCT06688682

Last Updated: 2024-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-10

Study Completion Date

2023-04-10

Brief Summary

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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

Detailed Description

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Conditions

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Early Knee Osseous Arthrophlogosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

90 subjects were randomly divided into three groups, with 30 cases in each group. (1) HA group: The patients were given intraarticular injection of sodium hyaluronate injection, 2ml each time, and normal saline injection of 1ml at Xuehai point, Yanglingquan point and Wezhong point, once a week for 4 weeks. (2) PRP joint cavity injection group: PRP knee cavity injection was given, 3.5ml each time, and normal saline injection was given at Xuechai point, Yanglingquan point and Weizhong point 1ml, once a week for 4 weeks; (3) PRP joint cavity combined with acupoint injection group: PRP was given intraventricular injection of knee joint, each injection was 3.5ml, while PRP was given 1ml injection of Xuehai point, Yanglingquan point and Weizhong point, once a week for 4 weeks.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type PLACEBO_COMPARATOR

PRP joint injection combined with acupoint injection

Intervention Type OTHER

PRP acupoint injection

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

Group Type EXPERIMENTAL

PRP joint injection combined with acupoint injection

Intervention Type OTHER

PRP acupoint injection

Interventions

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PRP joint injection combined with acupoint injection

PRP acupoint injection

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhengzhou Revo-Gene Technology Co., LTD

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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No.7, Wei Wu Road, Zhengzhou City

Zhengzhou, Henan, China

Site Status

Countries

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China

Other Identifiers

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RG2301

Identifier Type: -

Identifier Source: org_study_id

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