Knee OsteoarthritisNCT04088045
High Frequency Intensive Autologous PRP Injection and Genicular Nerve Blocks in Treating Knee Osteoarthritis
A study testing Autologous platelet rich plasma and 5% dextrose solution injections. in people with Knee Osteoarthritis, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Osteoarthritis (OA) of the knees is the most common degenerative disorder seen in a rehabilitation outpatient clinic. It is characterized by structural changes in the articular cartilage and the surrounding tissues. The understanding of its pathophysiology is still unclear. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Autologous platelet rich plasma and 5% dextrose solution injections.
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2019to 31 Jul 2021
- 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffered from chronic unilateral knee pain for more than 4 months and with roentgenogram degenerative findings of grades 3 and 4 on the Kellgren-Lawrence Classification of Osteoarthritis scale (meaning moderate to severe degrees of knee OA) will be recruited.
- The volume of the SF in the supra-patellar bursa region is enough (at least 2 mm thickness in bursa fluid as measured by ultrasound) to be aspirated via ultrasound guidance.
- Small volume of SF will be aspirated first and sent for SF analysis. SF showing evidences of crystals suggesting possible gouty arthritis and infection will not be included in this study.
- Patient has previously received oral NSAIDs and physical modality treatments but WITHOUT any obvious improvements in knee pain and function.
- The usage of musculoskeletal ultrasound to confirm that the supra-patellar bursa is in communication with the synovial cavity of the knee joint. This is to prevent the aspiration of isolated cystic lesion at the supra-patellar region.
Who cannot join
- Total obliteration of knee joint as shown on the roentgenogram images. Patient has systemic disorders such as diabetes, rheumatoid arthritis, major axial deviation of the knee joint (varus >5°, valgus >5°), hematological diseases (coagulopathy), severe cardiovascular diseases, infections, and immune-depression.
- Patients in therapy with anticoagulants, and taking NSAIDs within the 5 days before blood harvest
- Patients with hemoglobin value of less than 11 g/dl, and platelet counts of less than 150,000/mm3.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taoyuan, 33343
Shu-Yi Tseng, 03-3196200 ext. 3706, tsengshui@cgmh.org.tw
About this study
Official title: Exploring the Effectiveness of Combined High Frequency Intensive Autologous Platelet Rich Plasma Injection and Genicular Nerve Blocks in Treating Patients With Moderate to Severe Degrees of Knee Osteoarthritis
Osteoarthritis (OA) of the knees is the most common degenerative disorder seen in a rehabilitation outpatient clinic. It is characterized by structural changes in the articular cartilage and the surrounding tissues. The understanding of its pathophysiology is still unclear. Knee OA patients are often troubled with knee pain and functional disturbance. Several studies have shown that the earlier the injection of autologous platelet rich plasma (PRP) to treat early stages of knee OA, the better the treatment outcome. However, there are controversies as to whether PRP injections can also be effective in treating patients with moderate to severe degrees of knee OA. Synovial fluid (SF) is in contact with the primary tissues affected by OA (cartilage and synovium). Identifying the SF biomarkers can provide us with crucial information in monitoring the PRP treatment response.
PRP is blood plasma that is rich in autologous platelets. Platelet releases growth factors and cytokines that can stimulate the healing of soft tissue structures. However, the amount of platelets in human blood is not concentrated. Purification and centrifugation procedures are needed to concentrate these platelets. The human knee cartilage is contained inside the knee joint and has scarce blood supply. When the cartilage is injured, growth factors can hardly reach this area to repair the cartilage. Therefore, many studies have suggested early usage of PRP in treating knee OA. Some studies have stated that the effect of PRP in treating knee OA is superior to that of hyaluronic acid (HA). Recent studies have recommended the application of high frequency PRP injections (ex/ intra-articular (IA) PRP injections on a weekly basis) in treating patients with more severe degrees of knee OA. Prolotherapy using hyperosmolar dextrose solution has been shown to have some positive effectiveness in treating patients with knee OA. Higher percentage, such as > 12.5% of dextrose water, may stimulate cartilage repair. Lower percentage, such as 5% dextrose water, has been documented to play an essential role in anti-inflammation, and pain reduction.
Read the detailed description
Our previous study has documented that knee IA PRP injection combined with PRP injection to the pes anserine complex offered better treatment effectiveness as compared with IA PRP alone. In this two-year study, patients with moderate to severe degrees of knee OA will be recruited and divided into 3 groups. The high frequency PRP injection method will be applied (weekly PRP injections for a total of 3 weeks). Group 1 will receive knee IA PRP injections only. Group 2 will receive simultaneous knee IA PRP injections and PRP injections to the pes anserine complex. Group 3 will receive simultaneous knee IA PRP injections and PRP injections to the pes anserine complex, as well as to the genicular nerve blocks using 5% dextrose solution. We hypothesize that patients in group 3 will have better treatment outcomes. The effectiveness will be examined using proteomics, isokinetic measurements and functional scale evaluations. Upon the completion of this study, we will be able to gather adequate scientific evidences as to which injection approach and what PRP injection frequency is a better option in treating patients with moderate to severe degrees of knee OA.
- Conditions
- Knee Osteoarthritis
- Being tested
- Autologous platelet rich plasma and 5% dextrose solution injections.
- Keywords
- Osteoarthritis; Autologous Platelet Rich Plasma
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous platelet rich plasma and 5% dextrose solution injections.Device
One group of patients will receive autologous platelet rich plasma injection into the knee joint and pes anserinus complex. The other group will receive both PRP injections into the knee joint and pes anserinus complex, and prolotherapy of 5% dextrose solution to the genicular nerves.
Dextrose solutions are injected to the genicular nerves.
| Study group | Role | What they receive |
|---|---|---|
| Receiving PRP injections or PRP plus neural prolotherapy | Experimental | This experiment compares the effect of injecting PRP alone into the knee joint and pes anserinus complex with when dextrose solution is also injected to the genicular nerves.
The injection of dextrose solution is to decrease the inflammation of the genicular nerves, hoping to further effectively alleviate the knee pain condition. Therefore, upon the conclusion of this study, we can see whether the inclusion of dextrose injection in addition to PRP treatment can really be effective in treating patients with more severe degrees of knee OA. Receives: Device: Autologous platelet rich plasma and 5% dextrose solution injections. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lequesne knee osteoarthritis questionnaire
Lequesne knee osteoarthritis functional index includes distance, pain, and function. When added, an index score of > 7 indicates the possibility of knee osteoarthritis. The higher the score, the more severeness of knee osteoarthritis. When the index score is less than 7, the possibility of knee osteoarthritis is not high.
Measured: About 10 minutes are required to evaluate the score of LeQuesne index.
Two-dimensional electrophoresis (proteomics)
Hundreds of protein spots can be viewed on 2-dimensional electrophoresis gels. The intensity of each spot represents protein concentration.
Measured: Two days are required to measure the protein band intensities on the gels.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start1 Aug 2019
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Intervention model
- Sequential
- Model description
- Patients are divided into three groups. Group 1 will receive knee IA PRP injections only. Group 2 will receive simultaneous knee IA PRP injections and PRP injections to the pes anserine complex. Group 3 will receive simultaneous knee IA PRP injections and PRP injections to the pes anserine complex, as well as to the genicular nerve blocks using 5% dextrose solution.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carl P.C. Chen, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04088045
- Sponsor's protocol ID
- 20100378A3
- Status last verified
- Aug 2019
- First submitted
- 11 Sep 2019
- Last updated
- 8 Oct 2019
- Results posted
- 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 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effectiveness of Combined High Frequency Intensive Autologous Platelet Rich Plasma Injection and Genicular Nerve Blocks in Treating Patients With Moderate to Severe Degrees of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04088045
- Acronym / sponsor ID
- 20100378A3
- Conditions
- Knee Osteoarthritis
- Keywords
- Osteoarthritis; Autologous Platelet Rich Plasma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 12 Sep 2019 (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.
Osteoarthritis (OA) of the knees is the most common degenerative disorder seen in a rehabilitation outpatient clinic. It is characterized by structural changes in the articular cartilage and the surrounding tissues. The understanding of its pathophysiology is still unclear. Knee OA patients are often troubled with knee pain and functional disturbance. Several studies have shown that the earlier the injection of autologous platelet rich plasma (PRP) to treat early stages of knee OA, the better the treatment outcome. However, there are controversies as to whether PRP injections can also be effective in treating patients with moderate to severe degrees of knee OA. Synovial fluid (SF) is in contact with the primary tissues affected by OA (cartilage and synovium). Identifying the SF biomarkers can provide us with crucial information in monitoring the PRP treatment response.
PRP is blood plasma that is rich in autologous platelets. Platelet releases growth factors and cytokines that can stimulate the healing of soft tissue structures. However, the amount of platelets in human blood is not concentrated. Purification and centrifugation procedures are needed to concentrate these platelets. The human knee cartilage is contained inside the knee joint and has scarce blood supply. When the cartilage is injured, growth factors can hardly reach this area to repair the cartilage. Therefore, many studies have suggested early usage of PRP in treating knee OA. Some studies have stated that the effect of PRP in treating knee OA is superior to that of hyaluronic acid (HA). Recent studies have recommended the application of high frequency PRP injections (ex/ intra-articular (IA) PRP injections on a weekly basis) in treating patients with more severe degrees of knee OA. Prolotherapy using hyperosmolar dextrose solution has been shown to have some positive effectiveness in treating patients with knee OA. Higher percentage, such as > 12.5% of dextrose water, may stimulate cartilage repair. Lower percentage, such as 5% dextrose water, has been documented to play an essential role in anti-inflammation, and pain reduction.
Detailed description
Our previous study has documented that knee IA PRP injection combined with PRP injection to the pes anserine complex offered better treatment effectiveness as compared with IA PRP alone. In this two-year study, patients with moderate to severe degrees of knee OA will be recruited and divided into 3 groups. The high frequency PRP injection method will be applied (weekly PRP injections for a total of 3 weeks). Group 1 will receive knee IA PRP injections only. Group 2 will receive simultaneous knee IA PRP injections and PRP injections to the pes anserine complex. Group 3 will receive simultaneous knee IA PRP injections and PRP injections to the pes anserine complex, as well as to the genicular nerve blocks using 5% dextrose solution. We hypothesize that patients in group 3 will have better treatment outcomes. The effectiveness will be examined using proteomics, isokinetic measurements and functional scale evaluations. Upon the completion of this study, we will be able to gather adequate scientific evidences as to which injection approach and what PRP injection frequency is a better option in treating patients with moderate to severe degrees of knee OA.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients are divided into three groups. Group 1 will receive knee IA PRP injections only. Group 2 will receive simultaneous knee IA PRP injections and PRP injections to the pes anserine complex. Group 3 will receive simultaneous knee IA PRP injections and PRP injections to the pes anserine complex, as well as to the genicular nerve blocks using 5% dextrose solution.
| Arm | Type | Receives |
|---|---|---|
| Receiving PRP injections or PRP plus neural prolotherapy | Experimental | Device: Autologous platelet rich plasma and 5% dextrose solution injections.This experiment compares the effect of injecting PRP alone into the knee joint and pes anserinus complex with when dextrose solution is also injected to the genicular nerves. The injection of dextrose solution is to decrease the inflammation of the genicular nerves, hoping to further effectively alleviate the knee pain condition. Therefore, upon the conclusion of this study, we can see whether the inclusion of dextrose injection in addition to PRP treatment can really be effective in treating patients with more severe degrees of knee OA. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients suffered from chronic unilateral knee pain for more than 4 months and with roentgenogram degenerative findings of grades 3 and 4 on the Kellgren-Lawrence Classification of Osteoarthritis scale (meaning moderate to severe degrees of knee OA) will be recruited.
- The volume of the SF in the supra-patellar bursa region is enough (at least 2 mm thickness in bursa fluid as measured by ultrasound) to be aspirated via ultrasound guidance.
- Small volume of SF will be aspirated first and sent for SF analysis. SF showing evidences of crystals suggesting possible gouty arthritis and infection will not be included in this study.
- Patient has previously received oral NSAIDs and physical modality treatments but WITHOUT any obvious improvements in knee pain and function.
- The usage of musculoskeletal ultrasound to confirm that the supra-patellar bursa is in communication with the synovial cavity of the knee joint. This is to prevent the aspiration of isolated cystic lesion at the supra-patellar region.
Key exclusion criteria (3 listed)
- Total obliteration of knee joint as shown on the roentgenogram images. Patient has systemic disorders such as diabetes, rheumatoid arthritis, major axial deviation of the knee joint (varus >5°, valgus >5°), hematological diseases (coagulopathy), severe cardiovascular diseases, infections, and immune-depression.
- Patients in therapy with anticoagulants, and taking NSAIDs within the 5 days before blood harvest
- Patients with hemoglobin value of less than 11 g/dl, and platelet counts of less than 150,000/mm3.
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 |
|---|---|---|
| Autologous platelet rich plasma and 5% dextrose solution injections.One group of patients will receive autologous platelet rich plasma injection into the knee joint and pes anserinus complex. The other group will receive both PRP injections into the knee joint and pes anserinus complex, and prolotherapy of 5% dextrose solution to the genicular nerves. Dextrose solutions are injected to the genicular nerves. | Device | Receiving PRP injections or PRP plus neural prolotherapy |
Primary outcome
Lequesne knee osteoarthritis questionnaire
Time frame: About 10 minutes are required to evaluate the score of LeQuesne index.
Lequesne knee osteoarthritis functional index includes distance, pain, and function. When added, an index score of > 7 indicates the possibility of knee osteoarthritis. The higher the score, the more severeness of knee osteoarthritis. When the index score is less than 7, the possibility of knee osteoarthritis is not high.
Two-dimensional electrophoresis (proteomics)
Time frame: Two days are required to measure the protein band intensities on the gels.
Hundreds of protein spots can be viewed on 2-dimensional electrophoresis gels. The intensity of each spot represents protein concentration.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
- Individual participant dataSharing planned: No
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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.
Carl P.C. Chen principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous platelet rich plasma and 5% dextrose solution injections. in people with Knee Osteoarthritis, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 3 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: status not confirmed, as of the sponsor's last update on 8 Oct 2019. 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 Taiwan. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shu-Yi Tseng (03-3196200 ext. 3706, tsengshui@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lequesne knee osteoarthritis questionnaire (time frame: About 10 minutes are required to evaluate the score of LeQuesne index.). The study lists 2 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 8 Oct 2019; AzTrials last refreshed its copy on 6 Nov 2026.