Comparison of Suprascapular Notch and Midpoint Approaches in Pulsed Radiofrequency Treatment of the Suprascapular Nerve on Pain and Function in Patients With Chronic Shoulder Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Isokinetic Shoulder Abduction Peak Torque
研究概览
简要总结
This study aims to compare the effects of pulsed radiofrequency (PRF) treatment of the suprascapular nerve using suprascapular notch and midpoint approaches on pain, shoulder function, and muscle strength in patients with chronic shoulder pain due to rotator cuff tendinopathy. Patients will be randomly assigned to one of the two intervention groups. Clinical evaluations will include pain assessment using the Numeric Rating Scale (NRS), functional assessment using the Shoulder Pain and Disability Index (SPADI), and quality of life assessment using the Short Form-36 (SF-36). In addition, shoulder range of motion will be measured goniometrically, muscle thickness of the supraspinatus and infraspinatus will be evaluated by ultrasonography, and shoulder muscle strength will be assessed using an isokinetic dynamometer. Assessments will be performed at baseline, 24 hours, 1 month, and 3 months after the intervention. The results of this study are expected to provide evidence regarding the optimal approach for PRF treatment of the suprascapular nerve in patients with chronic shoulder pain.
详细描述
Chronic shoulder pain is a common musculoskeletal condition that significantly affects daily activities and quality of life. Rotator cuff tendinopathy is one of the most frequent causes of chronic shoulder pain. The suprascapular nerve plays a key role in shoulder pain transmission, and pulsed radiofrequency (PRF) of the suprascapular nerve has emerged as an effective minimally invasive treatment option.
Different anatomical approaches have been described for suprascapular nerve interventions, including the suprascapular notch and midpoint approaches. However, there is limited evidence comparing the clinical and functional outcomes of these approaches.
The aim of this prospective, randomized study is to compare the effects of PRF applied to the suprascapular nerve via suprascapular notch and midpoint approaches in patients with chronic shoulder pain due to rotator cuff tendinopathy. Patients will be randomly allocated into two groups according to the intervention approach.
Clinical evaluations will include pain assessment using the Numeric Rating Scale (NRS), functional evaluation using the Shoulder Pain and Disability Index (SPADI), and quality of life assessment using the Short Form-36 (SF-36). In addition, shoulder range of motion will be measured goniometrically. Muscle thickness of the supraspinatus and infraspinatus will be assessed using ultrasonography, and shoulder muscle strength will be evaluated using an isokinetic dynamometer.
Assessments will be performed at baseline, 24 hours, 1 month, and 3 months following the intervention. The primary outcome of the study is the change in shoulder muscle strength, while secondary outcomes include pain, functional status, and muscle thickness.
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
- 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 between 40 and 80 years
- •Patients with chronic shoulder pain lasting longer than 3 months
- •Patients diagnosed with rotator cuff-related shoulder pain
- •Patients who show at least 50% pain reduction after diagnostic suprascapular nerve block
- •Patients who provide written informed consent
排除标准
- •Adhesive capsulitis
- •Previous shoulder surgery
- •Full-thickness rotator cuff tear
- •Neurological disorders affecting the shoulder
- •Pacemaker
- •Coagulopathy or anticoagulant therapy contraindicating intervention
- •Infection at the injection site
- •Severe systemic disease
- •Pregnancy
- •Inability to comply with study protocol
结局指标
主要结局
Isokinetic Shoulder Abduction Peak Torque
时间窗: Baseline and 3 months
Isokinetic peak torque of shoulder abduction will be measured using an isokinetic dynamometer (ISOMED 2000). Measurements will be performed to evaluate changes in muscle strength.
次要结局
- Pain Intensity (NPRS)(Baseline, 24 hours, 1 month, and 3 months)
- Shoulder Function (SPADI)(Baseline, 1 month, and 3 months)
- Supraspinatus and Infraspinatus Muscle Thickness(Baseline and 3 months)
- Shoulder Range of Motion (ROM)(Baseline and 3 months)
- Quality of Life (SF-36)(Baseline and 3 months)
研究者
Ayşe Merve Ata
Principal Investigator
Ankara City Hospital Bilkent