Ultrasound Localization and Guided Injection for Superior Cluneal Nerve Entrapment

Low Back Pain Clinical Trial

Official title:

Precise Ultrasound Localization and Guided Injection for Superior Cluneal Nerve Entrapment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04478344
• Other study ID #: 201912037RINC
• Status: Recruiting
• Phase: N/A
• Start date: November 27, 2020
• Est. completion date: June 2023

Study information

• Verified date: December 2022
• Source: National Taiwan University Hospital
• Contact: Ke-Vin Chang, MD,PhD
• Phone: +886-23717101
• Email: kvchang011[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Exclusion criteria: 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 nerve block within 3 months.

Study design:

(1) To scan the SCN and thoracolumbar fascia by high-resolution 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.

Detail of the intervention

1. High-resolution ultrasound evaluation of buttock region to recognize the superior cluneal nerve in patients with SCN entrapment and healthy control. The transcutaneous electrical stimulation will be assisted device for confirming the diagnosis by subjective response of patients.

2. Collecting the LBP-related information, including physical examination results ((SLRT, Extension in one-leg standing, Gaeslen's test, Yeoman's test, compression test, distraction test, FABER test and ROM), lumbosacral and pelvic X-ray. Compare the related information with sonography results.

3. Intervention: single arm experiment design. Ultrasound guided perineural injection with 1 mL of 50% dextrose, 4 mL of 1% lidocaine, and 5 mL of 0.9 % normal saline to the site where SCN being entrapment, to evaluate the clinical efficacy of perineural injection to SCN entrapment.

Outcome measurement:

Primary outcome :

1. Visual analogue scale

2. Modified version of the Oswestry Disability Questionnaire used in the AAOS lumbar cluster

3. Short-Form-36 (SF-36)

at baseline one month and three months after injection

Secondary outcome:

1. Sonography (gray-scale/elastography) at baseline, one month and three months after injection

2. Pressure pain threshold

Statistical analysis:

Continuous variables

1. Student's t test: fit assumption of normal distribution

2. Mann-Whitney test: does not fit the assumption of normal distribution Categorical variables

1. Chi-square test 2. Fisher exact test: sparse data

Multivariate analysis:

Generalized Estimating Equations

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

• trauma

• acute compression fracture

• acute herniated disc

• underwent lumbar region nerve block within 3 months

Related Conditions & MeSH terms

• Charcot-Marie-Tooth Disease
• Hereditary Sensory and Motor Neuropathy
• Low Back Pain
• Nerve Compression Syndromes
• Nerve Entrapment Syndrome

Intervention

Other:
• Ultrasound guided hydrodissection of superior cluneal nerve
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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital, Bei-Hu Branch	Taipei	Wanhua District

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Ultrasound evaluation of SCN (Grey scale)	Measurement of cross sectional area (square millimeters) and record image	Measurement change between one month and baseline and between three months and baseline