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

NCT05329116 | Unknown

• 1 other identifier: PamukkaleU-Simsek-001
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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).

Conditions

Osteo Arthritis Knee

Keywords

Mesotherapy; Platelet-Rich Plasma; Osteo Arthritis Knee

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (3)

• WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)

  at the 1st and the 3rd months after the treatment.

• Range of Motion (ROM)

  at the 1st and the 3rd months after the treatment.

• Side Effect

  at the 1st and the 3rd months after the treatment.

Study Arms (2)

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.

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.

Drug: Lidocaine 2% Injectable Solution; Biological: Platelet-rich plasma

Interventions

Lidocaine 2% Injectable Solution 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

Also known as: pentoxifylline

Intra-articular PRP + periarticular mesotherapy

Platelet-rich plasma 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; Intra-articular PRP + periarticular mesotherapy

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Necmettin Yildiz: lead

Study Sites (1)

Pamukkale University

Denizli, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Lidocaine; Pentoxifylline

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Ayşe Şimşek

CONTACT

+905319698492; draysesimsek2@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 14, 2022
• Study Start: May 15, 2022
• Primary Completion: October 25, 2022
• Study Completion: December 25, 2022
• Last Updated: November 3, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)