Ultrasound Localization and Guided Injection for Superior Cluneal Nerve Entrapment

NCT04478344 | Unknown

• 1 other identifier: 201912037RINC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Nerve Entrapment Syndrome

Keywords

Ultrasonography; Superior cluneal nerve; Nerve entrapment; Prediction; Ultrasound-guided injection; Hydrodissection

Outcome Measures

Primary Outcomes (3)

• Oswestry Disability Questionnaire

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

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

• Short Form-36 Questionnaire

  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.

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

• Visual analogue scale

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

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

Secondary Outcomes (1)

• Ultrasound evaluation of SCN (Grey scale)

  Measurement change between one month and baseline and between three months and baseline

Study Arms (2)

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.

Other: Ultrasound guided hydrodissection of superior cluneal nerve

Control arm

NO INTERVENTION

Patients without superior cluneal nerve entrappment

Interventions

Ultrasound guided hydrodissection of superior cluneal nerve OTHER

Intervention procedure: hydrodissection to the superior cluneal nerve entrapment; Device for guidance of injection: high-resolution ultrasound ; Drug for injection: a mixture of 1 mL of 50% dextrose, 4 mL of 1% lidocaine, and 5 mL of 0.9% normal saline

Ultrasound guided hydrodissection to superior cluneal nerve

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital, Bei-Hu Branch

Taipei, Wanhua District, 108, Taiwan

RECRUITING

Related Publications (1)

• Wu WT, Mezian K, Nanka O, Chen LR, Ricci V, Lin CP, Chang KV, Ozcakar L. Enhancing diagnosis and treatment of superior cluneal nerve entrapment: cadaveric, clinical, and ultrasonographic insights. Insights Imaging. 2023 Jul 3;14(1):116. doi: 10.1186/s13244-023-01463-0.

  PMID: 37395948 DERIVED

MeSH Terms

Conditions

Low Back Pain; Charcot-Marie-Tooth Disease; Nerve Compression Syndromes

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hereditary Sensory and Motor Neuropathy; Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Officials

• Ke-Vin Chang, MD,PhD

  National Taiwan University Hospital Bei-Hu Branch

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ke-Vin Chang, MD,PhD

CONTACT

+886-23717101; kvchang011@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 20, 2020
• Study Start: November 27, 2020
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: June 28, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)