Comparison of the Effectiveness of Ultrasound-Guided Suprascapular Nerve Radiofrequency Ablation and Ultrasound-Guided Suprascapular Nerve Injection With Local Anesthetic and Corticosteroid in Patients With Chronic Shoulder Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Change in Shoulder Pain Intensity (VAS Score)
研究概览
简要总结
This study aims to compare the clinical effectiveness of two interventional treatments for chronic shoulder pain related to suprascapular nerve pathology: ultrasound-guided suprascapular nerve block and suprascapular nerve radiofrequency ablation (RFA).
A total of 104 patients with chronic shoulder pain were enrolled and assigned to one of the two treatment groups. Participants were evaluated at baseline, 1 month, and 3 months after the intervention. Outcome measures included pain intensity, functional disability, range of motion, kinesiophobia, quality of life, shoulder proprioception, and supraspinatus muscle and tendon thickness measured by ultrasound.
The primary aim of the study is to determine whether radiofrequency ablation provides more sustained pain relief and functional improvement compared with nerve block. The findings may help guide clinical decision-making in the management of chronic shoulder pain.
详细描述
Chronic shoulder pain is a common clinical condition that leads to functional limitation and reduced quality of life. This study aimed to compare the effectiveness of two interventional treatments in patients whose symptoms persisted despite conservative management: pulsed radiofrequency (PRF) of the suprascapular nerve under ultrasonographic guidance, and suprascapular nerve blockade with local anesthetic and corticosteroid.
Adult patients with at least 3 months of chronic shoulder pain, diagnosed with a shoulder pathology based on clinical evaluation and, when necessary, imaging, were included. Eligible participants underwent either PRF treatment or perineural injection of local anesthetic and corticosteroid. All patients were instructed in a home-based exercise program that included Codman exercises, scapular stabilization exercises, and strengthening of the internal and external rotator muscles.
All interventions were performed under real-time ultrasonographic guidance. For PRF, the suprascapular notch region was visualized, and a radiofrequency cannula was advanced toward the suprascapular nerve using an in-plane approach. Correct needle positioning was confirmed through standard sensory and motor stimulation techniques. PRF was then delivered at a maximum temperature of 42°C for a total duration of 6 minutes. At the end of the procedure, 2 mL of 2% lidocaine was administered.
In the nerve block group, a spinal needle was advanced to the perineural region using the in-plane technique. After negative aspiration, 4 mL of solution containing 2 mL of 2% lidocaine and 2 mL of methylprednisolone acetate was slowly injected, and appropriate perineural spread was confirmed sonographically.
Following each procedure, all patients were observed for at least 30 minutes and monitored for potential complications such as hematoma, infection, or neurological deficit. Mild procedural soreness was managed with ice application or simple analgesics as needed.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 75 years, male or female. Presence of shoulder pain and/or mobility limitation for at least 3 months. Failure to benefit from medical treatment and exercise-based conservative therapy.
- •Voluntary participation and ability to provide written informed consent for enrollment in the study.
排除标准
- •Age younger than 18 years or older than 75 years. Shoulder pain caused by non-shoulder conditions such as cervical radiculopathy or myofascial pain syndrome.
- •Presence of severe chronic respiratory disease. History of intra-articular, peri-articular, or suprascapular nerve injection, or use of physical therapy modalities applied to the affected shoulder within the past 3 months.
- •Diagnosis of fibromyalgia. Presence of complex regional pain syndrome, entrapment neuropathy, or vascular disease affecting the same upper extremity.
- •Coagulopathy or bleeding diathesis. Presence of inflammatory or malignant disease. Severe psychiatric disorder or mental condition impairing cooperation or compliance.
- •Refusal to participate or inability to provide informed consent.
结局指标
主要结局
Change in Shoulder Pain Intensity (VAS Score)
时间窗: Baseline, 1 month and 3 months after the intervention
Pain intensity will be assessed using a Visual Analog Scale (VAS) ranging from 0 to 10. The primary outcome is the change in pain score from baseline to 3 months between the PRF group and the nerve block group. Higher scores indicate greater pain intensity.
次要结局
- SPADI (Shoulder Pain and Disability Index) Score(Baseline, 1 month, 3 months)
- SF-12 (Short Form-12 Health Survey: PCS & MCS)(Baseline, 1 month, 3 months)
- Tampa Scale for Kinesiophobia(Baseline, 1 month, 3 months)
- Change in Shoulder Proprioception(Baseline, 1 month, 3 months)
- Change in Supraspinatus Muscle and Tendon Thickness(Baseline, 1 month, 3 months)
- Change in Shoulder Range of Motion(Baseline, 1 month, 3 months)
研究者
Nida Koçer Nazlıgül
Physical Medicine and Rehabilitation Specialist (Sponsor-Investigator)
Ankara City Hospital Bilkent