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Clinical Trials/NCT04478344
NCT04478344UnknownNot Applicable

Precise Ultrasound Localization and Guided Injection for Superior Cluneal Nerve Entrapment

National Taiwan University Hospital1 site in 1 country30 target enrollmentStarted: November 27, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
30
Locations
1
Primary Endpoint
Visual analogue scale

Study Overview

Brief Summary

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.

Detailed Description

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

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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

Exclusion Criteria

  • •non-mechanical low back pain
  • •referred low back pain (tumor, infection, inflammatory arthritis, Scheuermann disease,Paget disease, herpetic neuralgia)
  • •acute compression fracture
  • •acute herniated disc
  • •underwent lumbar region nerve block within 3 months

Arms & Interventions

Ultrasound guided hydrodissection to superior cluneal nerve

Experimental

Patients with superior cluneal nerve enttrappment given by ultrasound guided perineural injection with a mixture of 1 mL of 50% dextrose, 4 mL of 1% lidocaine, and 5 mL of 0.9% normal saline to superior cluneal nerve of affected side.

Intervention: Ultrasound guided hydrodissection of superior cluneal nerve (Other)

Control arm

No Intervention

Patients without superior cluneal nerve entrappment

Outcomes

Primary Outcomes

Visual analogue scale

Time Frame: 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.

Short Form-36 Questionnaire

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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