Proximal Versus Distal Superior Cluneal Nerve Block in Superior Cluneal Nerve Entrapment: A Prospective, Randomized, Single-Blind Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS)
研究概览
简要总结
Superior cluneal nerve (SCN) entrapment is an underdiagnosed cause of chronic low back and gluteal pain. Although diagnostic nerve block is considered the gold standard for confirming SCN entrapment, there is no consensus regarding the optimal injection approach. This prospective observational study aims to compare the clinical effectiveness of proximal and distal ultrasound-guided SCN block techniques in patients diagnosed with SCN entrapment. Pain intensity and functional outcomes will be evaluated over the follow-up period to assess differences between the two approaches.
详细描述
The primary objective of this study is to compare the effects of two different ultrasound-guided injection techniques on pain intensity, functional status, neuropathic pain components, and quality of life in patients with suspected superior cluneal nerve (SCN) entrapment. Pain severity will be assessed using the Visual Analog Scale (VAS), functional status using the Oswestry Disability Index (ODI), neuropathic pain components using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS), and quality of life using the Short Form-12 (SF-12). The study aims to determine which injection technique provides superior clinical outcomes.
The secondary objective is to evaluate lumbosacral angle, lumbar lordosis angle, pelvic tilt, sacral tilt, and the presence of scoliosis, and to investigate the relationship between these postural and radiological parameters, SCN entrapment, and treatment response.
Through this study, ultrasound-guided injection techniques used in the diagnosis and treatment of SCN entrapment will be comparatively evaluated, addressing an important gap in the current literature and providing high-level scientific evidence to guide clinicians in the management of chronic low back and gluteal pain.
This study is designed as a prospective, randomized, single-blind clinical study comparing two different ultrasound-guided injection techniques in patients with suspected superior cluneal nerve entrapment. The study population will consist of patients presenting to the Algology Outpatient Clinic of Health Sciences University Gaziosmanpaşa Physical Medicine and Rehabilitation Training and Research Hospital during the study period, who meet the inclusion and exclusion criteria, have chronic low back and/or gluteal pain, are suspected of having SCN entrapment based on clinical examination, have not benefited from conservative treatment, and voluntarily agree to participate in the study.
Based on a power analysis with 95% power, a total of 54 patients are planned to be included in the study, with 27 patients allocated to each group.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age between 18 and 75 years
- •Chronic low back and/or gluteal pain lasting longer than 3 months
- •Localized point tenderness and/or paresthesia on palpation over the unilateral posterior iliac crest
- •Clinical suspicion of superior cluneal nerve entrapment based on physical examination
- •Failure to respond to conservative treatment
- •Ability and willingness to provide written informed consent
排除标准
- •Active local or systemic infection
- •Cognitive impairment or psychiatric disorders interfering with study participation
- •History of malignancy or cancer-related pain
- •Uncontrolled diabetes mellitus or severe comorbid conditions adversely affecting general health
- •Pregnancy
- •Known allergy to the medications used in the injection
- •Prominent radicular pain associated with neurological deficit
- •History of interventional procedures applied to the lumbar region within the last 6 months
- •Initiation of another lumbar interventional or medical treatment during the follow-up period
- •Suspected bilateral superior cluneal nerve entrapment
- •Sphincter dysfunction related to neurological disease
- •Bleeding diathesis or coagulation disorders
研究组 & 干预措施
Distal SCN Injection (Ultrasound-Guided)
Ultrasound-guided distal perineural approach for suspected superior cluneal nerve entrapment.
干预措施: Ultrasound-guided distal superior cluneal nerve injection (Procedure)
Proximal SCN Injection (Ultrasound-Guided)
Ultrasound-guided proximal interfascial (plane block) approach for suspected superior cluneal nerve entrapment.
干预措施: Ultrasound-guided proximal superior cluneal nerve injection (Procedure)
结局指标
主要结局
Visual Analog Scale (VAS)
时间窗: Baseline, 1 month, and 3 months
Primary Outcome Measure Visual Analog Scale for Pain (VAS): Change in pain intensity assessed using the Visual Analog Scale (VAS).The VAS is a 10-cm horizontal scale ranging from 0 (no pain) to 10 (worst imaginable pain).Higher scores indicate greater pain intensity, and a reduction in VAS score represents clinical improvement.
次要结局
- Oswestry Disability Index (ODI)(Baseline, 1 month, and 3 months)
- Leeds Assessment of Neuropathic Symptoms and Signs (LANSS)(Baseline, 1 month, and 3 months)
- Short Form-12 Health Survey (SF-12)(Baseline, 1 month, and 3 months)
- Baseline Postural and Radiological Characteristics in Patients with Superior Cluneal Nerve Entrapment(Baseline (pre-intervention))