跳至主要内容
临床试验/NCT04478344
NCT04478344招募中不适用

Precise Ultrasound Localization and Guided Injection for Superior Cluneal Nerve Entrapment

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年11月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Short Form-36 Questionnaire

研究概览

简要总结

Low back pain (LBP) is a common complaint in the clinical setting. Among all the differential diagnosis for LBP, superior cluneal nerve (SCN) entrapment is the commonly omitted one. The superior cluneal nerve is the terminal branch of the lateral branches of the posterior rami of the L1-L3 spinal nerves, which passes through the osseous tunnel interposed between the thoracolumbar fascia and iliac crest. This nerve can be entrapped due to poor posture, trauma or stretching of the surrounding thoracolumbar fascia and osseous membrane. The cardinal symptom of the superior cluneal nerve entrapment is buttock pain. Sometimes the pain may radiate to the lower limb, which mimics sciatica, and makes the diagnosis difficult. Early diagnosis and treatment of SCN entrapment is crucial, which can facilitate the improvement of health related quality of life and decrement the socioeconomic loss due to disability.

The study aims is (1) to scan the SCN and thoracolumbar fascia by ultrasound in patients with LBP and normal subjects. The transcutaneous electrical stimulation will be used to confirm the location of SCN by asking the subject to depict the sensory distribution after stimulation; (2) to analyze the related factors of LBP with SCN entrapment, which may help in setting up the diagnostic criteria of SCN entrapment; (3) to analyze the therapeutic effect of perineural injection to SCN in SCN entrapment, and to find the factors that related responsiveness.

详细描述

Introduction:

Superior cluneal nerve (SCN) entrapment is the commonly omitted diagnosis in chronic low back pain. The superior cluneal nerve is the terminal branch of the lateral branches of the posterior rami of the L1-L3 spinal nerves, which passes through the osseous tunnel interposed between the thoracolumbar fascia and iliac crest. This nerve can be entrapped due to poor posture, trauma or stretching of the surrounding thoracolumbar fascia and osseous membrane. The cardinal symptom of the superior cluneal nerve entrapment is buttock pain. Sometimes the pain may radiate to the lower limb, which mimics sciatica, and makes the diagnosis difficult. Early diagnosis and treatment of SCN entrapment is crucial, which can facilitate the improvement of health related quality of life and decrement the socioeconomic loss due to disability.

Material and methods:

Participants: Adult patients (>20 year old) with low back/buttock pain. The pain consists area of iliac crest.

Control : healthy adult subjects (>20 year old) without low back

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Short Form-36 Questionnaire

时间窗: Change of the score between one month and baseline, and change of the score between three month and baseline

Reflect 8 domains of health, including physical functioning, physical role, pain, general health, vitality, social func-tion, emotional role, and mental health. The categories of physical role and emotional role reflect performance at the activity and participation levels. The score will be transformed between 0 to 100. The higher score means better health condition in each domain.

Oswestry Disability Questionnaire

时间窗: Change of the score between one month and baseline, and change of the score between three months and baseline

Oswestry Disability Questionnaire, A 10 item questionnaire, score ranges from 0 to 100, and a higher score indicates worse function.

Visual analogue scale

时间窗: Change of the score between one month and baseline, and change of the score between three months and baseline

The pain scale to evaluate pain, from 0 to 10. The lower means less pain.

次要结局

  • Ultrasound evaluation of SCN (Grey scale)(Measurement change between one month and baseline and between three months and baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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