Autologous Platelet Rich Fibrin Versus Steroid in Ultrasound-Guided Sacroiliac Joint Injection for Joint Dysfunction (Randomized Comparative Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Pain assessment by VAS score
研究概览
简要总结
Low back pain is one of the commonest complaints nowadays affecting nearly 20% of the population, Sacroiliac joint has been accused of being the primary cause of pain in about 10%: 27% of this population.
The sure diagnosis of sacroiliac joint pain is challenging because of multiple crossed factors of facet joint pain and intervertebral disc pain. Diagnosis can be done by history taking, local examination, imaging techniques, and controlled local anesthetic blocks.
Controlled local anesthetic blocks are diagnostic and therapeutic done by various methods either landmark-guided or imaging-assisted either by fluoroscopy, computed tomography (CT), magnetic resonance (MRI), or ultrasound-guided.
Lower cost, real-time viewing of needle leading to higher accuracy rate, and low ionizing radiation dose are favoring ultrasound-guided injection over other modalities.
Numerous treatment modalities are being used for sacroiliac joint pain ranging from physiotherapy and systemic analgesics like Non-steroidal anti-inflammatory drugs (NSAIDs) to minimally invasive intra-articular, periarticular injection, radiofrequency neurotomy, and surgical fusion of the joint.
Multiple injectates are being used for intraarticular injection most commonly local anesthetics and steroids which offer short-term symptomatic relief and delay the degenerative process.
The need for a longer duration effect directly affects the disease process itself aiming for accelerating the joint healing rate by biological growth factors found in human blood especially in platelets.
Platelet-rich plasma (PRP) has been used aiming to inject a high concentration of growth factors directly into the joint.
Platelet-rich fibrin (PRF), the second generation of platelet-rich plasma is now tried having the advantage of a simpler preparation and higher values of growth factors.
详细描述
Patient preparation:
History taking, physical examination, provocation tests (Gaenslen's test, Patrick's test, and Compression & distraction test), and investigations will be done according to the local protocol designed to evaluate these patients. This includes complete blood count, random blood glucose, serum creatinine & electrolytes, liver function tests, coagulation profile, and electrocardiogram (ECG).
Before the intervention, the participants will be informed about the visual analog scale (VAS) pain score (0-100 mm) (where 0=no pain and 100 = worst comprehensible pain) and the details of the procedures.
The patient will receive Midazolam 2 mg intravenous (IV) as a premedication. Intravenous access will be obtained with a 20-gauge intravenous (IV) cannula and monitors (pulse oximeter, electrocardiography, non-invasive blood pressure) will be applied.
We will use a high-frequency ultrasound probe .and a 22-gauge, 50 mm echogenic needle for performing the injection.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged >18 years with Low back pain > 6 months.
- •Failure of conservative treatment for 3 months.
- •Positive findings on at least one of three provocation tests for sacroiliac joint pain: Gaenslen's test, Patrick's test, and compression & distraction test.
- •Positive diagnostic injection (pain reduction >80% after injection).
排除标准
- •Patient refusal.
- •Disorders in the hip joint.
- •Signs of lumbar radiculopathy.
- •Bleeding disorders including anticoagulation medications.
- •Positive response to Kemp's test (pain provocation test for sciatica).
- •Infection at site of injection.
- •Psychiatric problems as prevent completion of the study related questionnaires.
- •Morbid obesity BMI >
- •Severe cardiac and respiratory disorders.
研究组 & 干预措施
Platelet rich fibrin Group
Platelet rich fibrin. Group P
干预措施: intra-articular Platelet rich fibrin and lidocaine (Biological)
Methylprednisolone acetate
Group S
干预措施: methylprednisolone acetate and lidocaine (Drug)
结局指标
主要结局
Pain assessment by VAS score
时间窗: 1 month after procedure
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
次要结局
- patient discomfort with procedure(5 minutes after procedure)
- weight(5 minutes before procedure)
- Height(5 minutes before procedure)
- Age(5 minutes before procedure)
- Pain assessment by VAS score(6 month after procedure)
- Patient satisfaction with procedure(1 month after procedure)
- Modified Oswestry Disability Index(6 month after procedure)
- hematoma(5 minutes after procedure)
- Allergy(10 minutes after procedure)
- BMI(5 minutes before procedure)
- Analgesic requirement after injection(1 day after procedure)
研究者
Amr hamdy Mahmoud
Assistant lecturer
Fayoum University Hospital