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Efficacy of Mesotherapy Added to Intra-articular Platelet-rich Plasma (PRP) in Patients With Knee Osteoarthritis

Primary Purpose

Osteo Arthritis Knee

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Lidocaine 2% Injectable Solution
Platelet-rich plasma
Sponsored by
Necmettin Yildiz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee focused on measuring Mesotherapy, Platelet-Rich Plasma, Osteo Arthritis Knee

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients aged 40-80 years
  • To be diagnosed with knee OA according to the diagnosis of ACR
  • Ability to give informed consent

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Pamukkale UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Intra-articular PRP

Intra-articular PRP + periarticular mesotherapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
Side Effect
Side effects observed at the end of treatment in both groups will be reported.

Full Information

First Posted
March 23, 2022
Last Updated
October 31, 2022
Sponsor
Necmettin Yildiz
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1. Study Identification

Unique Protocol Identification Number
NCT05329116
Brief Title
Efficacy of Mesotherapy Added to Intra-articular Platelet-rich Plasma (PRP) in Patients With Knee Osteoarthritis
Official Title
Efficacy of Mesotherapy Added to Intra-articular Platelet-rich Plasma (PRP) in Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2022 (Actual)
Primary Completion Date
October 25, 2022 (Actual)
Study Completion Date
December 25, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Necmettin Yildiz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee
Keywords
Mesotherapy, Platelet-Rich Plasma, Osteo Arthritis Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intra-articular PRP
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intra-articular PRP + periarticular mesotherapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lidocaine 2% Injectable Solution
Other Intervention Name(s)
pentoxifylline
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
Platelet-rich plasma
Intervention Description
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
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
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.
Time Frame
Change from Baseline VAS at 1st month after the treatment.
Title
Visual Analogue Scale (VAS)
Description
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.
Time Frame
Change from Baseline VAS at 3rd month after the treatment.
Title
Visual Analogue Scale (VAS)
Description
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.
Time Frame
Change from 1st month VAS at 3rd month after the treatment.
Secondary Outcome Measure Information:
Title
WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)
Description
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.
Time Frame
at the 1st and the 3rd months after the treatment.
Title
Range of Motion (ROM)
Description
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.
Time Frame
at the 1st and the 3rd months after the treatment.
Title
Side Effect
Description
Side effects observed at the end of treatment in both groups will be reported.
Time Frame
at the 1st and the 3rd months after the treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 40-80 years To be diagnosed with knee OA according to the diagnosis of ACR Ability to give informed consent Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ayşe Şimşek
Phone
+905319698492
Email
draysesimsek2@gmail.com
Facility Information:
Facility Name
Pamukkale University
City
Denizli
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Necmettin Yıldız

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy of Mesotherapy Added to Intra-articular Platelet-rich Plasma (PRP) in Patients With Knee Osteoarthritis

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