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

N

Necmettin Yildiz

Status

Enrolling

Conditions

Osteo Arthritis Knee

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05329116
PamukkaleU-Simsek-001

Details and patient eligibility

About

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).

Full 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.

Enrollment

42 estimated patients

Sex

All

Ages

40 to 80 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

42 participants in 2 patient groups

Intra-articular PRP
Active Comparator group
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.
Treatment:
Biological: Platelet-rich plasma
Intra-articular PRP + periarticular mesotherapy
Active Comparator group
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.
Treatment:
Biological: Platelet-rich plasma
Drug: Lidocaine 2% Injectable Solution

Trial contacts and locations

1

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Central trial contact

Ayşe Şimşek

Data sourced from clinicaltrials.gov

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