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Ultrasound Localization and Guided Injection for Superior Cluneal Nerve Entrapment

Primary Purpose

Low Back Pain, Nerve Entrapment Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Ultrasound guided hydrodissection of superior cluneal nerve
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Ultrasonography, Superior cluneal nerve, Nerve entrapment, Prediction, Ultrasound-guided injection, Hydrodissection

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Participants:

  • Adult patients (>20 year old) with low back/buttock pain > 4 weeks or recurrent low back/buttock pain >2 times per year.
  • 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

Sites / Locations

  • National Taiwan University Hospital, Bei-Hu BranchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Ultrasound guided hydrodissection to superior cluneal nerve

Control arm

Arm Description

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.

Patients without superior cluneal nerve entrappment

Outcomes

Primary Outcome Measures

Oswestry Disability Questionnaire
Oswestry Disability Questionnaire, A 10 item questionnaire, score ranges from 0 to 100, and a higher score indicates worse function.
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.
Visual analogue scale
The pain scale to evaluate pain, from 0 to 10. The lower means less pain.

Secondary Outcome Measures

Ultrasound evaluation of SCN (Grey scale)
Measurement of cross sectional area (square millimeters) and record image

Full Information

First Posted
July 9, 2020
Last Updated
June 25, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04478344
Brief Title
Ultrasound Localization and Guided Injection for Superior Cluneal Nerve Entrapment
Official Title
Precise Ultrasound Localization and Guided Injection for Superior Cluneal Nerve Entrapment
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 27, 2020 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 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 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. 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. 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 : Visual analogue scale Modified version of the Oswestry Disability Questionnaire used in the AAOS lumbar cluster Short-Form-36 (SF-36) at baseline one month and three months after injection Secondary outcome: Sonography (gray-scale/elastography) at baseline, one month and three months after injection Pressure pain threshold Statistical analysis: Continuous variables Student's t test: fit assumption of normal distribution 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Nerve Entrapment Syndrome
Keywords
Ultrasonography, Superior cluneal nerve, Nerve entrapment, Prediction, Ultrasound-guided injection, Hydrodissection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound guided hydrodissection to superior cluneal nerve
Arm Type
Experimental
Arm Description
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.
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
Patients without superior cluneal nerve entrappment
Intervention Type
Other
Intervention Name(s)
Ultrasound guided hydrodissection of superior cluneal nerve
Intervention Description
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
Primary Outcome Measure Information:
Title
Oswestry Disability Questionnaire
Description
Oswestry Disability Questionnaire, A 10 item questionnaire, score ranges from 0 to 100, and a higher score indicates worse function.
Time Frame
Change of the score between one month and baseline, and change of the score between three months and baseline
Title
Short Form-36 Questionnaire
Description
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.
Time Frame
Change of the score between one month and baseline, and change of the score between three month and baseline
Title
Visual analogue scale
Description
The pain scale to evaluate pain, from 0 to 10. The lower means less pain.
Time Frame
Change of the score between one month and baseline, and change of the score between three months and baseline
Secondary Outcome Measure Information:
Title
Ultrasound evaluation of SCN (Grey scale)
Description
Measurement of cross sectional area (square millimeters) and record image
Time Frame
Measurement change between one month and baseline and between three months and baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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) trauma acute compression fracture acute herniated disc underwent lumbar region nerve block within 3 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ke-Vin Chang, MD,PhD
Phone
+886-23717101
Ext
5309
Email
kvchang011@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ke-Vin Chang, MD,PhD
Organizational Affiliation
National Taiwan University Hospital, Bei-Hu Branch
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital, Bei-Hu Branch
City
Taipei
State/Province
Wanhua District
ZIP/Postal Code
108
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
Email
kvchang011@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Ultrasound Localization and Guided Injection for Superior Cluneal Nerve Entrapment

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