Osteo Arthritis KneeNCT05329116
Efficacy of Mesotherapy Added to Intra-articular Platelet-rich Plasma (PRP) in Patients With Knee Osteoarthritis
A study testing Lidocaine 2% Injectable Solution and Platelet-rich plasma in people with Osteo Arthritis Knee, run by Necmettin Yildiz at 1 site in Turkey (Türkiye).
Trial summary
In this study, the investigators aimed to determine whether platelet rich plasma (PRP) and mesotherapy combined treatment is effective on pain and function compared to PRP alone in patients with knee osteoarthritis (OA). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Lidocaine 2% Injectable Solution and Platelet-rich plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2022to 25 Dec 2022
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 40-80 years
- To be diagnosed with knee OA according to the diagnosis of ACR
- Ability to give informed consent
Who cannot join
- History or symptoms of lower extremity surgery, ligament injury, balance disorder or lower extremity injury in the last 6 months
- Allergic to lidocaine, other local anesthetics and pentoxifylline
- Intra and periarticular injection in the last 3 months
- Use of NSAIDs for pain relief in the past 7 days
- Presence of local or systemic infection
- cancer history
Show all 12Show fewer
- Heart failure, cardiac arrhythmia
- Bleeding diathesis, antiaggregant, anticoagulant use
- Cerebral hemorrhage
- Pregnancy or breastfeeding
- Presence of psychiatric or neurological disease affecting cooperation, cognitive and neurological functions
- Inability to complete the survey
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Pamukkale University
Denizli
Necmettin Yıldız
About this study
Official title: Efficacy of Mesotherapy Added to Intra-articular Platelet-rich Plasma (PRP) in Patients
In this study, the investigators aimed to determine whether platelet rich plasma (PRP) and mesotherapy combined treatment is effective on pain and function compared to PRP alone in patients with knee osteoarthritis (OA).
Read the detailed description
42 patients diagnosed with knee OA according to the criteria of the American College of Rheumatology (ACR) (15) who applied to Physical Medicine and Rehabilitation outpatient clinic will be recruited. Patients' age, gender, occupation, medications, duration of diagnosis, body mass index, comorbidity, functional status and pain will be questioned.
After the participants are informed about the study, their consent will be obtained.
Patients will be randomized using a random numbers table. The first group will receive intra-articular PRP therapy. The second group will receive mesotherapy treatment in addition to PRP treatment.
Group 1: Intra-articular PRP:
For PRP treatment, 8 mL of peripheral blood will be taken from the patient and centrifuged at 4000 rpm for 8 minutes. Then, 3-4 mL of PRP will be taken and used for intra-articular injection (16). Patients will receive a single session of PRP treatment.
Group 2: Intra-articular PRP + periarticular mesotherapy In addition to single session PRP treatment, patients will receive 3 weeks of mesotherapy treatment once a week (the first session will be with PRP treatment).
Sterile and disposable needle tip (0.26mm × 4mm and 0.3mm × 13 mm, Terumo) will be used in mesotherapy. Patients will be administered 1.5 ml of 2% lidocaine, 1.5 ml of 30 mg of pentoxifylline.
Among the injection techniques, profundal intradermic injection (IDP, injection depth: 2-4 mm) and superficial intradermic injection (IDS, injection depth: 1-2 mm) will be used (14).
All patients will be evaluated with the following evaluation parameters before the treatment, at the 1st month and at the 3rd month after the treatment.
- Conditions
- Osteo Arthritis Knee
- Being tested
- Lidocaine 2% Injectable Solution, Platelet-rich plasma
- Keywords
- Mesotherapy, Platelet-Rich Plasma, Osteo Arthritis Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 2% Injectable SolutionDrug
Also called pentoxifylline
Patients will be administered 1.5 ml of 2% lidocaine, 1.5 ml of 30 mg of pentoxifylline.
Among the injection techniques, profundal intradermic injection (IDP, injection depth: 2-4 mm) and superficial intradermic injection (IDS, injection depth: 1-2 mm) will be used.
8 mL of peripheral blood will be taken from the patient and centrifuged at 4000 rpm for 8 minutes. Then, 3-4 mL of PRP will be taken and used for intra-articular injection
Platelet-rich plasmaBiological
8 mL of peripheral blood will be taken from the patient and centrifuged at 4000 rpm for 8 minutes. Then, 3-4 mL of PRP will be taken and used for intra-articular injection
| Study group | Role | What they receive |
|---|---|---|
| Intra-articular PRP | Active comparator | For PRP treatment, 8 mL of peripheral blood will be taken from the patient and centrifuged at 4000 rpm for 8 minutes. Then, 3-4 mL of PRP will be taken and used for intra-articular injection. Patients will receive a single session of PRP treatment. Receives: Biological: Platelet-rich plasma |
| Intra-articular PRP + periarticular mesotherapy | Active comparator | In addition to single session PRP treatment, patients will receive 3 weeks of mesotherapy treatment once a week (the first session will be with PRP treatment).
Sterile and disposable needle tip (0.26mm × 4mm and 0.3mm × 13 mm, Terumo) will be used in mesotherapy. Patients will be administered 1.5 ml of 2% lidocaine, 1.5 ml of 30 mg of pentoxifylline.
Among the injection techniques, profundal intradermic injection (IDP, injection depth: 2-4 mm) and superficial intradermic injection (IDS, injection depth: 1-2 mm) will be used. Receives: Drug: Lidocaine 2% Injectable Solution; Biological: Platelet-rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
The pain score will be measured using a 10 cm millimetric visual analog scale (VAS), where patients are asked to mark the degree of pain intensity from 0 (no pain) to 10 (worst pain imaginable) before and after treatment.
Measured: Change from Baseline VAS at 1st month after the treatment.
Visual Analogue Scale (VAS)
The pain score will be measured using a 10 cm millimetric visual analog scale (VAS), where patients are asked to mark the degree of pain intensity from 0 (no pain) to 10 (worst pain imaginable) before and after treatment.
Measured: Change from Baseline VAS at 3rd month after the treatment.
Visual Analogue Scale (VAS)
The pain score will be measured using a 10 cm millimetric visual analog scale (VAS), where patients are asked to mark the degree of pain intensity from 0 (no pain) to 10 (worst pain imaginable) before and after treatment.
Measured: Change from 1st month VAS at 3rd month after the treatment.
Secondary outcomes (3)
WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)
The evaluation of pain, stiffness and physical functions of the patients included in the study before and after treatment will be made using the Turkish version of the WOMAC criterion. WOMAC is a specific, valid and reliable criterion for OA and includes 24 questions under three sub-headings: pain, stiffness and physical function. Each question was scored on a Likert scale as 0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe. The score of each section is calculated on its own and the total score ranges from 0 to 100. High scores indicate increased pain and stiffness and impaired physical function.
Measured: at the 1st and the 3rd months after the treatment.
Range of Motion (ROM)
The normal ROM of the knee is 135 degrees in flexion and 0 in extension. The knee ROM of the patients included in the study will be measured and recorded before and after the treatment.
Measured: at the 1st and the 3rd months after the treatment.
Side Effect
Side effects observed at the end of treatment in both groups will be reported.
Measured: at the 1st and the 3rd months after the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start15 May 2022
- Primary completion25 Oct 2022
- Study completion25 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Necmettin Yildiz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Necmettin Yildiz, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329116
- Sponsor's protocol ID
- PamukkaleU-Simsek-001
- Status last verified
- Oct 2022
- First submitted
- 23 Mar 2022
- Last updated
- 3 Nov 2022
- 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 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Mesotherapy Added to Intra-articular Platelet-rich Plasma (PRP) in Patients
- ClinicalTrials.gov ID
- NCT05329116
- Acronym / sponsor ID
- PamukkaleU-Simsek-001
- Conditions
- Osteo Arthritis Knee
- Keywords
- Mesotherapy, Platelet-Rich Plasma, Osteo Arthritis Knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Necmettin YildizUniversity, hospital or other
- Study start
- 15 May 2022 (actual)
- Primary completion
- 25 Oct 2022 (actual)
- Study completion
- 25 Dec 2022 (estimated)
- First posted
- 14 Apr 2022 (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.
In this study, the investigators aimed to determine whether platelet rich plasma (PRP) and mesotherapy combined treatment is effective on pain and function compared to PRP alone in patients with knee osteoarthritis (OA).
Detailed description
42 patients diagnosed with knee OA according to the criteria of the American College of Rheumatology (ACR) (15) who applied to Physical Medicine and Rehabilitation outpatient clinic will be recruited. Patients' age, gender, occupation, medications, duration of diagnosis, body mass index, comorbidity, functional status and pain will be questioned.
After the participants are informed about the study, their consent will be obtained.
Patients will be randomized using a random numbers table. The first group will receive intra-articular PRP therapy. The second group will receive mesotherapy treatment in addition to PRP treatment.
Group 1: Intra-articular PRP:
For PRP treatment, 8 mL of peripheral blood will be taken from the patient and centrifuged at 4000 rpm for 8 minutes. Then, 3-4 mL of PRP will be taken and used for intra-articular injection (16). Patients will receive a single session of PRP treatment.
Group 2: Intra-articular PRP + periarticular mesotherapy In addition to single session PRP treatment, patients will receive 3 weeks of mesotherapy treatment once a week (the first session will be with PRP treatment).
Sterile and disposable needle tip (0.26mm × 4mm and 0.3mm × 13 mm, Terumo) will be used in mesotherapy. Patients will be administered 1.5 ml of 2% lidocaine, 1.5 ml of 30 mg of pentoxifylline.
Among the injection techniques, profundal intradermic injection (IDP, injection depth: 2-4 mm) and superficial intradermic injection (IDS, injection depth: 1-2 mm) will be used (14).
All patients will be evaluated with the following evaluation parameters before the treatment, at the 1st month and at the 3rd month after the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-articular PRP | Active comparator | Biological: Platelet-rich plasmaFor PRP treatment, 8 mL of peripheral blood will be taken from the patient and centrifuged at 4000 rpm for 8 minutes. Then, 3-4 mL of PRP will be taken and used for intra-articular injection. Patients will receive a single session of PRP treatment. |
| Intra-articular PRP + periarticular mesotherapy | Active comparator | Drug: Lidocaine 2% Injectable Solution, Biological: Platelet-rich plasmaIn addition to single session PRP treatment, patients will receive 3 weeks of mesotherapy treatment once a week (the first session will be with PRP treatment). Sterile and disposable needle tip (0.26mm × 4mm and 0.3mm × 13 mm, Terumo) will be used in mesotherapy. Patients will be administered 1.5 ml of 2% lidocaine, 1.5 ml of 30 mg of pentoxifylline. Among the injection techniques, profundal intradermic injection (IDP, injection depth: 2-4 mm) and superficial intradermic injection (IDS, injection depth: 1-2 mm) will be used. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 40-80 years
- To be diagnosed with knee OA according to the diagnosis of ACR
- Ability to give informed consent
Key exclusion criteria (12 listed)
- History or symptoms of lower extremity surgery, ligament injury, balance disorder or lower extremity injury in the last 6 months
- Allergic to lidocaine, other local anesthetics and pentoxifylline
- Intra and periarticular injection in the last 3 months
- Use of NSAIDs for pain relief in the past 7 days
- Presence of local or systemic infection
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 |
|---|---|---|
| Lidocaine 2% Injectable SolutionAlso: pentoxifyllinePatients will be administered 1.5 ml of 2% lidocaine, 1.5 ml of 30 mg of pentoxifylline. Among the injection techniques, profundal intradermic injection (IDP, injection depth: 2-4 mm) and superficial intradermic injection (IDS, injection depth: 1-2 mm) will be used. 8 mL of peripheral blood will be taken from the patient and centrifuged at 4000 rpm for 8 minutes. Then, 3-4 mL of PRP will be taken and used for intra-articular injection | Drug | Intra-articular PRP + periarticular mesotherapy |
| Platelet-rich plasma8 mL of peripheral blood will be taken from the patient and centrifuged at 4000 rpm for 8 minutes. Then, 3-4 mL of PRP will be taken and used for intra-articular injection | Biological | Intra-articular PRP, Intra-articular PRP + periarticular mesotherapy |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: Change from Baseline VAS at 1st month after the treatment.
The pain score will be measured using a 10 cm millimetric visual analog scale (VAS), where patients are asked to mark the degree of pain intensity from 0 (no pain) to 10 (worst pain imaginable) before and after treatment.
Visual Analogue Scale (VAS)
Time frame: Change from Baseline VAS at 3rd month after the treatment.
The pain score will be measured using a 10 cm millimetric visual analog scale (VAS), where patients are asked to mark the degree of pain intensity from 0 (no pain) to 10 (worst pain imaginable) before and after treatment.
Visual Analogue Scale (VAS)
Time frame: Change from 1st month VAS at 3rd month after the treatment.
The pain score will be measured using a 10 cm millimetric visual analog scale (VAS), where patients are asked to mark the degree of pain intensity from 0 (no pain) to 10 (worst pain imaginable) before and after treatment.
3 secondary outcomes
WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)
Time frame: at the 1st and the 3rd months after the treatment.
Range of Motion (ROM)
Time frame: at the 1st and the 3rd months after the treatment.
Side Effect
Time frame: at the 1st and the 3rd months after the treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine 2% Injectable Solution and Platelet-rich plasma in people with Osteo Arthritis Knee, run by Necmettin Yildiz at 1 site in Turkey (Türkiye).
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 3 inclusion and 12 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 3 Nov 2022. 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 Turkey (Türkiye). 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 Ayşe Şimşek (+905319698492, draysesimsek2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: Change from Baseline VAS at 1st month after the 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 3 Nov 2022.