NCT05329116

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Necmettin Yildiz · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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
BIOLOGICAL	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

Timeline

• Start date: 2022-05-15
• Primary completion: 2022-10-25
• Completion: 2022-12-25
• First posted: 2022-04-14
• Last updated: 2022-11-03

Locations

1 site across 1 country: Turkey (Türkiye)