NCT05303597

Brief Summary

Cluneal nerves are a group of pure sensory nerves that provide direct cutaneous innervation to the buttocks. Superior cluneal nerve(SCN) originates from the T11-L5 nerve roots and has at least 3 branches from medial to lateral; these are the medial, intermediate, and lateral branches. Anatomy studies have shown that the medial branch passes 6-7 cm lateral to the midline on the posterior iliac crest. Nerve branches pass through the osteofibrous tunnel formed by the thoracolumbar fascia and the superior edge of the iliac crest, where they can be trapped. Controversial data exist regarding the osteofibrous tunnel. It may not be present in all cases, and in some cases more than one nerve has been shown to pass through the osteofibrous tunnel. As a result, there are discussions about superior cluneal nerve anatomy and there is not enough information. In patients with superior cluneal nerve entrapment syndrome, low back pain radiates to the upper part of the hip and may cause leg pain that mimics radiculopathy. The diagnosis is clinical. Diagnostic criteria for superior cluneal nerve (SCN) entrapment; Low back pain involving the iliac crest and buttocks, symptoms aggravated by lumbar movement or posture, trigger point over the posterior iliac crest corresponding to the nerve compression zone, patients report numbness and radiating pain in the SCN area (Tinel sign) when the trigger point is compressed, symptom relief by SCN block at the trigger point. Prevalence studies of superior cluneal nerve entrapment syndrome are very few. Maigne et al reported superior cluneal nerve entrapment in 1.6% of 1,800 patients with low back pain. Kuniya et al showed that 14% of 834 patients with low back pain met the criteria for superior cluneal nerve entrapment. Superior cluneal nerve entrapment is not as rare as it is thought to be among the causes of low back pain. In Turkey, there is no study showing the prevalence of the superior cluneal nerve or its importance in patients with low back pain. The aim of this study is to examine the patients who applied to Cerrahpasa Faculty of Medicine, Department of Physical Medicine and Rehabilitation polyclinic with low back pain; To confirm the diagnosis with an ultrasound-guided diagnostic injection test, to determine the importance of superior cluneal nerve entrapment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

April 2, 2024

Status Verified

March 1, 2024

Enrollment Period

2 months

First QC Date

March 22, 2022

Last Update Submit

March 30, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • More than 70% reduction in pain with diagnostic nerve block

    200 patients who applied to the outpatient clinic with low back pain will be examined and patients with posterior iliac crest pain will be given a diagnostic injection under ultrasound guidance with a preliminary diagnosis of superior cluneal nerve entrapment.

    two months

Study Arms (1)

diagnostic superior cluneal nerve block

OTHER

Patients with low back pain will be evaluated by two physicians. The clinical history and physical examination of all patients with low back pain will be taken by the first physician. Patients with a trigger point in the posterior iliac crest will be evaluated by a second physician and diagnostic nerve block will be performed ultrasound-guided with the preliminary diagnosis of superior cluneal nerve entrapment. General Electric LogiqP5 model ultrasound device will be used and lidocaine will be applied between the posterior iliac crest and thoracolumbar fascia, which is viewed under the guidance of ultrasonography, for diagnosis and treatment. Patients who have had a diagnostic injection will be re-evaluated 1 hour later. Patients whose pain is reduced by more than 70% will be diagnosed with superior cluneal nerve entrapment.

Diagnostic Test: ultrasound-guided diagnostic nerve block with lidocaine

Interventions

Patients with a trigger point in the posterior iliac crest will be evaluated by a second physician and diagnostic nerve block will be performed ultrasound-guided with the preliminary diagnosis of superior cluneal nerve entrapment. General Electric LogiqP5 model ultrasound device will be used and lidocaine will be applied between the posterior iliac crest and thoracolumbar fascia, which is viewed under the guidance of ultrasonography, for diagnosis and treatment.

diagnostic superior cluneal nerve block

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older with mechanical low back pain for more than 3 months
  • Without a history of neurological or psychiatric disease
  • No history of inflammatory disease
  • Patients without a history of trauma in the last 3 months

You may not qualify if:

  • Age younger than 18 and over 80
  • Having a history of acute trauma in the last 3 months
  • Presence of inflammatory rheumatic disease (RA, Ankylosing spondylitis, Polymyalgia rheumatica, vasculitides etc.)
  • Patients who have been injected (steroid, hyaluronic acid, etc.) in the last 6 weeks
  • Presence of active infection
  • The use of anticoagulants that may interfere with the injection
  • Presence of bleeding disorder
  • Known allergy to injection agents
  • Presence of uncontrolled diabetes mellitus and/or hypertension
  • Presence of heart failure
  • History of malignancy
  • Having a history of neurological disease
  • Pregnancy, lactation
  • Psychiatric disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul Üniversitesi - Cerrahpasa (IUC)

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back PainCharcot-Marie-Tooth DiseasePain

Condition Hierarchy (Ancestors)

Back PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsHereditary Sensory and Motor NeuropathyNervous System MalformationsNervous System DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesPolyneuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, Inborn

Study Officials

  • Kenan Akgun

    Istanbul University - Cerrahpasa

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
residency doctor

Study Record Dates

First Submitted

March 22, 2022

First Posted

March 31, 2022

Study Start

April 1, 2022

Primary Completion

June 1, 2022

Study Completion

July 1, 2022

Last Updated

April 2, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations