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

NCT ID: NCT05329116

Last Updated: 2022-11-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-15
• Study Completion Date: 2022-12-25

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.

Conditions

Osteo Arthritis Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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. Patients will receive a single session of PRP treatment.

Group Type: ACTIVE_COMPARATOR

Platelet-rich plasma

Intervention Type: BIOLOGICAL

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

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.

Group Type: ACTIVE_COMPARATOR

Lidocaine 2% Injectable Solution

Intervention Type: DRUG

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 plasma

Intervention Type: BIOLOGICAL

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

Interventions

Lidocaine 2% Injectable Solution

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: DRUG

Platelet-rich plasma

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

Other Intervention Names

pentoxifylline

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Necmettin Yildiz

OTHER

Sponsor Role: lead

Responsible Party

Necmettin Yildiz

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Pamukkale University

Denizli, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Ayşe Şimşek

Role: CONTACT

draysesimsek2@gmail.com

+905319698492

Facility Contacts

Necmettin Yıldız

Role: primary

Other Identifiers

PamukkaleU-Simsek-001

Identifier Type: -

Identifier Source: org_study_id