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

Osteo Arthritis Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05329116
• Other study ID #: PamukkaleU-Simsek-001
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2022
• Est. completion date: December 25, 2022

Study information

• Verified date: October 2022
• Source: Pamukkale University
• Contact: Ayse Simsek
• Phone: +905319698492
• Email: draysesimsek2[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: December 25, 2022
• Est. primary completion date: October 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
Turkey	Pamukkale University	Denizli

Sponsors (1)

Lead Sponsor	Collaborator
Necmettin Yildiz

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from Baseline VAS at 1st month after the treatment.
Primary	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.	Change from Baseline VAS at 3rd month after the treatment.
Primary	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.	Change from 1st month VAS at 3rd month after the treatment.
Secondary	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.	at the 1st and the 3rd months after the treatment.
Secondary	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.	at the 1st and the 3rd months after the treatment.
Secondary	Side Effect	Side effects observed at the end of treatment in both groups will be reported.	at the 1st and the 3rd months after the treatment.