Clinical trial NCT06688682: Effect of PRP Joint Cavity Combined with Acupoint Injection on Osteoarthritis of Knee Joint
Official title: Effect of PRP Joint Cavity Combined with Acupoint Injection on Osteoarthritis of Knee Joint
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Knee Osseous Arthrophlogosis
Lead sponsor: Zhengzhou Revo-Gene Technology Co., LTD
Sponsor class: NETWORK
First posted: 2024-11-14
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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.

Primary outcomes:
measure: Visual Analog Scale (VAS) score
timeFrame: Assessments will be conducted at weeks 1, 3, 6, and 12 after treatment.
measure: Knee Society Score (KSS)
timeFrame: Assessments will be conducted at weeks 1, 3, 6, and 12 after treatment.
measure: Western Ontario and McMaster Universities Osteoarthritis Index
timeFrame: Assessments will be conducted at 1, 3, 6, and 12 months after treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: No.7, Wei Wu Road, Zhengzhou City
state: Henan
Study officials:
References: