Early Knee Osseous ArthrophlogosisNCT06688682
Effect of PRP Joint Cavity Combined with Acupoint Injection on Osteoarthritis of Knee Joint
A study testing PRP joint injection combined with acupoint injection in people with Early Knee Osseous Arthrophlogosis, run by Zhengzhou Revo-Gene Technology Co., LTD at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Early Knee Osseous Arthrophlogosis
- What is being tested?
- PRP joint injection combined with acupoint injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2023to 10 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Early Knee Osseous Arthrophlogosis
- Being tested
- PRP joint injection combined with acupoint injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP joint injection combined with acupoint injectionOther
PRP acupoint injection
| Study group | Role | What they receive |
|---|---|---|
| HA group | No intervention | 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 |
| PRP joint injection group | Placebo comparator | 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 Receives: Other: PRP joint injection combined with acupoint injection |
| PRP joint injection combined with acupoint injection group | Experimental | 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 Receives: Other: PRP joint injection combined with acupoint injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) score
Visual Analog Scale (VAS) score ranging from 1 to 10, with lower scores indicating less pain intensity
Measured: 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
Measured: 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.
Measured: Assessments will be conducted at 1, 3, 6, and 12 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start10 Apr 2023
- Primary completion10 Apr 2023
- Study completion10 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Knee Osseous ArthrophlogosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhengzhou Revo-Gene Technology Co., LTD
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06688682
- Sponsor's protocol ID
- RG2301
- Status last verified
- Nov 2024
- First submitted
- 9 Nov 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of PRP Joint Cavity Combined with Acupoint Injection on Osteoarthritis of Knee Joint
- ClinicalTrials.gov ID
- NCT06688682
- Acronym / sponsor ID
- RG2301
- Conditions
- Early Knee Osseous Arthrophlogosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Zhengzhou Revo-Gene Technology Co., LTDResearch network
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 10 Apr 2023 (actual)
- First posted
- 14 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| HA group | No intervention | –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 |
| PRP joint injection group | Placebo comparator | Other: PRP joint injection combined with acupoint injectiontreated 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 |
| PRP joint injection combined with acupoint injection group | Experimental | Other: PRP joint injection combined with acupoint injectiontreated 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRP joint injection combined with acupoint injectionPRP acupoint injection | Other | PRP joint injection combined with acupoint injection group, PRP joint injection group |
Primary outcome
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
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP joint injection combined with acupoint injection in people with Early Knee Osseous Arthrophlogosis, run by Zhengzhou Revo-Gene Technology Co., LTD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) score (time frame: Assessments will be conducted at weeks 1, 3, 6, and 12 after treatment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.