Knee OsteoarthritisNCT04006314
Platelet Rich Plasma and Neural Prolotherapy Injections in Treating Knee Osteoarthritis
A study testing Autologous platelet rich plasma and dextrose solution. 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 metabolic, biochemical, and structural changes in the articular cartilage and the surrounding tissues. 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 dextrose solution.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Sep 2018to 31 Jul 2020
- 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 Simultaneous Autologous Platelet Rich Plasma and Neural Prolotherapy Injections 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 metabolic, biochemical, and structural changes in the articular cartilage and the surrounding tissues. 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 (a PRP) to treat early stages of knee OA, the better the treatment outcome. However, no consensus has been reached as to whether PRP injection is beneficial for patients with moderate to severe degrees of knee OA. Studies have also shown that the application of neural prolotherapy (NPT) to the genicular nerves may have beneficial effects in treating patients with severe knee OA. However, patients may start to walk for a longer period of time due to reduced knee pain after NPT. If the regenerative effect of PRP is not yet obvious on the knee cartilage, this excess walking may result in further destruction of the knee joints. No studies have examined the combined treatment effect of a PRP and NPT on patients with moderate to severe degrees of knee OA.
NPT is the injection of low percentage dextrose water (5%) with the rationale to repair and reduce pain caused by the nerves. We would like to bring our PRP study to a higher level by conducting a two-year study to recruit patients with moderate to severe degrees of knee OA. PRP will be injected into the knee joint and the pes anserine tendons. Simultaneous NPT will also be performed to the genicular nerves. The effectiveness will be examined using proteomics, isokinetic measurements and functional scale evaluations. Synovial fluid (SF) is in direct contact with the cartilage and synovium, protein biomarkers related to the disease pathophysiology of knee OA are contained within the SF and will be used for proteomic analysis. Patients will receive monthly injections for a total of 3 months. In short, if inflammatory proteins in the SF are not reduced after PRP injections, this indicates that PRP is not a good treatment choice for patients with moderate to severe degrees of knee OA. If inflammatory protein concentrations are further increased after NPT as patients may start strenuous exercises with reduced knee pain, more knee joint destruction may result.
Read the detailed description
Patients will receive monthly injections for a total of 3 months. In short, if inflammatory proteins in the SF are not reduced after PRP injections, this indicates that PRP is not a good treatment choice for patients with moderate to severe degrees of knee OA. If inflammatory protein concentrations are further increased after NPT as patients may start strenuous exercises with reduced knee pain, more knee joint destruction may result. This signifies that NPT has pain reduction effect only and is not a viable treatment option. Roentgenograms may not show immediate signs of increased degeneration on the knee joints, but SF proteomic findings can provide us with evidences suggesting whether there is ongoing knee joint destruction. Upon the completion of this study, adequate scientific evidences will be gathered to know whether simultaneous PRP and NPT injections is a feasible option in treating patients with moderate to severe degrees of knee OA.
- Conditions
- Knee Osteoarthritis
- Being tested
- Autologous platelet rich plasma and dextrose solution.
- Keywords
- platelet rich plasma; neural prolotherapy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous platelet rich plasma and dextrose solution.Other
Autologous platelet rich plasma are injected into the knee joint and pes anserinus complex.
Dextrose solutions are injected to the genicular nerves.
| Study group | Role | What they receive |
|---|---|---|
| Receiving PRP injections or PRP plus neural prolotherapy | Other | PRP injection into the knee joint and pes anserinus complex. Dextrose solution to the genicular nerves. Receives: Other: Autologous platelet rich plasma and dextrose solution. |
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 which includes distance, pain, and function.
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 posted5 Jul 2019
- Study start4 Sep 2018
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Jul 2020 (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 two groups. One group receiving PRP injections only. One group receiving PRP plus neural prolotherapy injections.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carl P.C. Chen, Chang Gung Memorial Hospital
- Investigators
- Carl P.C. Chen, MD, PhD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04006314
- Sponsor's protocol ID
- 201701924A3
- Status last verified
- Jun 2019
- First submitted
- 26 Jun 2019
- Last updated
- 5 Jul 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 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effectiveness of Simultaneous Autologous Platelet Rich Plasma and Neural Prolotherapy Injections in Treating Patients With Moderate to Severe Degrees of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04006314
- Acronym / sponsor ID
- 201701924A3
- Conditions
- Knee Osteoarthritis
- Keywords
- platelet rich plasma; neural prolotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 5 Jul 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 metabolic, biochemical, and structural changes in the articular cartilage and the surrounding tissues. 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 (a PRP) to treat early stages of knee OA, the better the treatment outcome. However, no consensus has been reached as to whether PRP injection is beneficial for patients with moderate to severe degrees of knee OA. Studies have also shown that the application of neural prolotherapy (NPT) to the genicular nerves may have beneficial effects in treating patients with severe knee OA. However, patients may start to walk for a longer period of time due to reduced knee pain after NPT. If the regenerative effect of PRP is not yet obvious on the knee cartilage, this excess walking may result in further destruction of the knee joints. No studies have examined the combined treatment effect of a PRP and NPT on patients with moderate to severe degrees of knee OA.
NPT is the injection of low percentage dextrose water (5%) with the rationale to repair and reduce pain caused by the nerves. We would like to bring our PRP study to a higher level by conducting a two-year study to recruit patients with moderate to severe degrees of knee OA. PRP will be injected into the knee joint and the pes anserine tendons. Simultaneous NPT will also be performed to the genicular nerves. The effectiveness will be examined using proteomics, isokinetic measurements and functional scale evaluations. Synovial fluid (SF) is in direct contact with the cartilage and synovium, protein biomarkers related to the disease pathophysiology of knee OA are contained within the SF and will be used for proteomic analysis. Patients will receive monthly injections for a total of 3 months. In short, if inflammatory proteins in the SF are not reduced after PRP injections, this indicates that PRP is not a good treatment choice for patients with moderate to severe degrees of knee OA. If inflammatory protein concentrations are further increased after NPT as patients may start strenuous exercises with reduced knee pain, more knee joint destruction may result.
Detailed description
Patients will receive monthly injections for a total of 3 months. In short, if inflammatory proteins in the SF are not reduced after PRP injections, this indicates that PRP is not a good treatment choice for patients with moderate to severe degrees of knee OA. If inflammatory protein concentrations are further increased after NPT as patients may start strenuous exercises with reduced knee pain, more knee joint destruction may result. This signifies that NPT has pain reduction effect only and is not a viable treatment option. Roentgenograms may not show immediate signs of increased degeneration on the knee joints, but SF proteomic findings can provide us with evidences suggesting whether there is ongoing knee joint destruction. Upon the completion of this study, adequate scientific evidences will be gathered to know whether simultaneous PRP and NPT injections is a feasible 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 two groups. One group receiving PRP injections only. One group receiving PRP plus neural prolotherapy injections.
| Arm | Type | Receives |
|---|---|---|
| Receiving PRP injections or PRP plus neural prolotherapy | Other | Other: Autologous platelet rich plasma and dextrose solution.PRP injection into the knee joint and pes anserinus complex. Dextrose solution to the genicular nerves. |
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 (4 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 dextrose solution.Autologous platelet rich plasma are injected into the knee joint and pes anserinus complex. Dextrose solutions are injected to the genicular nerves. | Other | 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 which includes distance, pain, and function.
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 5 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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, MD, PhD 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 dextrose solution. 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 4 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 5 Jul 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 5 Jul 2019.