Low Back PainNCT05303597
The Frequency of Superior Cluneal Nerve Entrapment Diagnosed With Ultrasound Guided Nerve Block
A study testing ultrasound-guided diagnostic nerve block with lidocaine in people with Low Back Pain and Nerve Entrapment Syndrome, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Low Back Pain, Nerve Entrapment Syndrome, Radiating Pain
- What is being tested?
- ultrasound-guided diagnostic nerve block with lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İstanbul Üniversitesi - Cerrahpasa (IUC)
Istanbul
About this study
Official title: The Frequency of Superior Cluneal Nerve Entrapment Diagnosed With Ultrasound Guided Nerve Block In Patients With Low Back Pain: A Prospective, Cross-Sectional Study
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.
Read more
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.
Read the detailed description
Patients with low back pain will be examined by two doctors. 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.
- Conditions
- Low Back Pain, Nerve Entrapment Syndrome, Radiating Pain
- Being tested
- ultrasound-guided diagnostic nerve block with lidocaine
- Medical subject headings
- Low Back Pain, Charcot-Marie-Tooth Disease, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound-guided diagnostic nerve block with lidocaineDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: ultrasound-guided diagnostic nerve block with lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 Apr 2022
- Primary completion1 Jun 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Busra Sezer Kıral, Istanbul University - Cerrahpasa
- Investigators
- Kenan Akgun, Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05303597
- Sponsor's protocol ID
- IstanbulUC,BSKıral,001
- Status last verified
- Mar 2024
- First submitted
- 22 Mar 2022
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Frequency of Superior Cluneal Nerve Entrapment Diagnosed With Ultrasound Guided Nerve Block In Patients With Low Back Pain: A Prospective, Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT05303597
- Acronym / sponsor ID
- IstanbulUC,BSKıral,001
- Conditions
- Low Back Pain, Nerve Entrapment Syndrome, Radiating Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients with low back pain will be examined by two doctors. 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diagnostic superior cluneal nerve block | Other | Diagnostic Test: ultrasound-guided diagnostic nerve block with lidocainePatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound-guided diagnostic nerve block with lidocainePatients 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 test | diagnostic superior cluneal nerve block |
Primary outcome
More than 70% reduction in pain with diagnostic nerve block
Time frame: two months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenan Akgun study director
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound-guided diagnostic nerve block with lidocaine in people with Low Back Pain and Nerve Entrapment Syndrome, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
More than 70% reduction in pain with diagnostic nerve block (time frame: two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.