Comparison of Local Steroid Injection With Platelet Rich Plasma in the Treatment of Carpal Tunnel Syndrome
试验速览
- 阶段
- 3 期
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- median nerve sensory conduction velocity
研究概览
简要总结
The aim of this study is to evaluate the effect of local platelet rich plasma injection therapy in patients with mild to moderate idiopathic carpal tunnel syndrome (CTS) with clinical and electrophysiological parameters. Also the effect of platelet rich plasma and local steroid injection will be compared.
详细描述
Research sample; Voluntary female patients who are referred to the Physical Therapy and Rehabilitation Outpatient Clinic and who have a clinical and electrophysiological diagnosis of mild or moderate CTS. Patients aged between 25-70 years and who have complaints consistent with CTS for more than 3 months will be selected.
The size of the sample was determined by the preliminary statistical study conducted using the NCSS-PASS 12 program, and will consist of 84 patients.
Patients will be randomly allocated to one of two groups. Local platelet rich plasma (PRP) injection in the first group (n = 42) and local steroid injection in the second group (n = 42) will be performed once into the carpal tunnel. PRP will be obtained by centrifugation of autologous anticoagulated whole blood. 6.43 mg of betamethasone dipropionate and 2.63 mg of betamethasone sodium phosphate will be administered as local steroids. Both groups will be recommended a resting splint for use in the day time when possible and at night time. Clinical and electrophysiological evaluations of all patients will be performed by a researcher who is blinded to the treatment received by the patient. The electrophysiological and clinical evaluations of the patients will be done by the same investigator before and after the 1st and 3rd months of therapy. At one and three month follow up, Symptom severity and functional capacity will be assessed using the Boston Carpal Tunnel Syndrome Questionnaire. The hand grip strength of the patients will be assessed using a Jamar hand dynamometer ( (Baseline hydraulic hand dynomometer, Irvington, NY, USA) and the finger holding power by pinchmeter. Conventional motor and sensory nerve conduction studies will be applied as electrodiagnostic studies.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The patient will not be informed about which group will be taken. Randomization will be performed by a simple randomization method by a researcher who is blind to the clinical and electrophysiological findings. The injection will be performed by a second researcher who is blind to the contents of the injection. The evaluations of the patients will be performed by a researcher who is blinded to the treatment applied and the initial assessment.
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female patient 25-75 years old
- •Symptoms consistent with carpal tunnel syndrome for at least 3 months
- •Clinical and electrophysiological diagnosis of mild to moderate carpal tunnel syndrome
- •Written informed consent obtained
排除标准
- •Electrophysiological diagnosis of proximal median nerve neuropathy, cervical radiculopathy, brachial plexopathy, thoracic outlet syndrome
- •Those with a past medical history of diabetes mellitus, hypothyroidism, pregnancy, chronic inflammatory rheumatic disease, renal insufficiency which may predispose to CTS
- •Patients with a history of wrist surgery or radius distal tip fracture
- •Patients who underwent carpal tunnel local steroid injection within the previous 3 months
- •Patients with a cardiac pacemaker
- •History of hematological disease (coagulopathy) or patients receiving anticoagulant or antiaggregant therapy
- •Severe cardiovascular disease
- •Infection, immunosuppression
- •Patients using non-steroidal anti-inflammatory drugs up to 5 days before PRP injection patients with hemoglobin levels below 11 and platelet levels below 150,000
研究组 & 干预措施
Platelet rich plasma (PRP) -T lab PRP kit
A single 1ml PRP extract injection will be will be injected into the carpal tunnel of the wrist in which a diagnosis of carpel tunnel syndrome has been established. A 23 gauge needle will used to perform the injection through the distal wrist creased into the carpal tunnel. performed once into the carpal tunnel in the wrist . PRP will be obtained by centrifugation of autologous anticoagulated whole blood.
干预措施: Local platelet rich plasma (PRP) injection-T-Lab PRP kit (Drug)
Diprospan ®, Schering Plough
A single steroid injection (1 ml Diprospan ®, Schering Plough containing 6.43 mg of betamethasone dipropionate and 2.63 mg of betamethasone sodium phosphate) will be injected into the carpal tunnel of the wrist in which a diagnosis of carpel tunnel syndrome has been established. A 23 gauge needle will used to perform the injection through the distal wrist creased into the carpal tunnel.
干预措施: Local steroid injection-Diprospan ®, Schering Plough (Drug)
结局指标
主要结局
median nerve sensory conduction velocity
时间窗: 3 months
median nerve sensory conduction velocity in the palm wrist segment
次要结局
未报告次要终点
研究者
Sevgi Ikbali Afsar
Associate Professor
Baskent University