Efficacy of Mesotherapy Added to Intra-articular Platelet-rich Plasma (PRP) in Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale (VAS)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 40-80 years
- •To be diagnosed with knee OA according to the diagnosis of ACR
- •Ability to give informed consent
排除标准
- •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
研究组 & 干预措施
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. Patients will receive a single session of PRP treatment.
干预措施: Platelet-rich plasma (Biological)
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.
干预措施: Lidocaine 2% Injectable Solution (Drug)
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.
干预措施: Platelet-rich plasma (Biological)
结局指标
主要结局
Visual Analogue Scale (VAS)
时间窗: Change from 1st month VAS at 3rd month after the treatment.
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.
次要结局
- Side Effect(at the 1st and the 3rd months after the treatment.)
- Range of Motion (ROM)(at the 1st and the 3rd months after the treatment.)
- WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)(at the 1st and the 3rd months after the treatment.)
研究者
Necmettin Yildiz
Clinical Professor
Pamukkale University