Clinical trial NCT05329116: Efficacy of Mesotherapy Added to Intra-articular Platelet-rich Plasma (PRP) in Patients With Knee Osteoarthritis
Official title: Efficacy of Mesotherapy Added to Intra-articular Platelet-rich Plasma (PRP) in Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteo Arthritis Knee
Keywords: Mesotherapy
Platelet-Rich Plasma
Osteo Arthritis Knee
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 42
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: Change from Baseline VAS at 1st month after the treatment.
measure: Visual Analogue Scale (VAS)
timeFrame: Change from Baseline VAS at 3rd month after the treatment.
measure: Visual Analogue Scale (VAS)
timeFrame: Change from 1st month VAS at 3rd month after the treatment.
Secondary outcomes:
measure: WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)
timeFrame: at the 1st and the 3rd months after the treatment.
measure: Range of Motion (ROM)
timeFrame: at the 1st and the 3rd months after the treatment.
measure: Side Effect
timeFrame: at the 1st and the 3rd months after the treatment.
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
References: