Ultrasound Localization and Guided Injection for Superior Cluneal Nerve Entrapment

June 25, 2023 updated by: National Taiwan University Hospital

Precise Ultrasound Localization and Guided Injection for Superior Cluneal Nerve Entrapment

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

  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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
    • Wanhua District
      • Taipei, Wanhua District, Taiwan, 108
        • Recruiting
        • National Taiwan University Hospital, Bei-Hu Branch
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control arm
Patients without superior cluneal nerve entrappment
Experimental: Ultrasound guided hydrodissection to superior cluneal nerve
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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Change of the score between one month and baseline, and change of the score between three months and baseline
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.
Change of the score between one month and baseline, and change of the score between three month and baseline
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.
Change of the score between one month and baseline, and change of the score between three months and baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ultrasound evaluation of SCN (Grey scale)
Time Frame: Measurement change between one month and baseline and between three months and baseline
Measurement of cross sectional area (square millimeters) and record image
Measurement change between one month and baseline and between three months and baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ke-Vin Chang, MD,PhD, National Taiwan University Hospital, Bei-Hu Branch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 27, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201912037RINC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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