Superior Cluneal Nerve EntrapmentNCT06059612
Treatment of Upper Cluneal Nerve Entrapment Syndrome for Reduction of Low Back Pain
A study testing injection in people with Superior Cluneal Nerve Entrapment, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
Superior cluneal nerve entrapment (SCN) is a painful symptomatic condition related to compression by the thoracolumbar and gluteal bands of nerve outcrop, above the iliac crest. This syndrome is not considered in the classical differential diagnosis of lumbosacral spine disorders and is almost unknown in Italy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Superior Cluneal Nerve Entrapment
- What is being tested?
- injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteItaly
- Study dates
- 20 Jan 2022to 10 Feb 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with age between 18 and 99 years
- male and female sex
- superior cluneal nerve trigger point positivity at clinical evaluation
- absence of urgent criteria for spinal surgery
Who cannot join
- patients younger than 18 years old
- patients who have not given consent to be included in the study
- patients with negative upper cluneal nerve trigger point - emergency criteria for spine surgery
- pregnant women - patients allergic to local anesthetic
- patients with language barrier
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Upper Cluneal Nerve Entrapment Syndrome for Reduction of Low Back Pain: Single-arm Experimental Study
Superior cluneal nerve entrapment (SCN) is a painful symptomatic condition related to compression by the thoracolumbar and gluteal bands of nerve outcrop, above the iliac crest. This syndrome is not considered in the classical differential diagnosis of lumbosacral spine disorders and is almost unknown in Italy.
It is a neuropathic pain, acute, subacute, or chronic, evoked by mechanical stress at the level of the sensory territory corresponding to the superior cluneal nerve, easily found anatomically and evoked at a trigger point on the posterior iliac crest approximately 70mm from the midline and 45mm from the posterior superior iliac spine.
SCN entrapment syndrome represents a not so infrequent syndrome. It is easily framed and treatment is effective in most cases. Therefore, diagnosis and treatment of this syndrome represents an excellent option in all those patients with low back pain that cannot be otherwise framed and resolved.
- Conditions
- Superior Cluneal Nerve Entrapment
- Being tested
- injection
- Keywords
- Superior cluneal nerve, nerve entrapment
- Medical subject headings
- Nerve Compression Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injectionProcedure or surgery
steroid injection into superior cluneal nerve
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Superior cluneal nerve entrapment (SCN) will be treated with local steroid injection Receives: Procedure: injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
numerical rating scale (NRS)
NRS is a numerical scale for assessing pain exclusively. It is precisely a numerical scale ranging from 0 to 10 where the degree of pain perceived by the patient is expressed in an increasing manner. The value 0 corresponds to the 'absence of pain, the valor
Measured: at baseline (day 0)
numerical rating scale (NRS)
NRS is a numerical scale for assessing pain exclusively. It is precisely a numerical scale ranging from 0 to 10 where the degree of pain perceived by the patient is expressed in an increasing manner. The value 0 corresponds to the 'absence of pain, the valor
Measured: after 45 days
Owestry Disability Index (ODI)
The ODI score is a scorecard on daily activities and the degree of limitation experienced by the patient with low back pain.
The form consists of 10 multiple-choice questions (5 options) regarding different aspects of daily life such as pain intensity, personal care, walking, climbing stairs, standing up, sleeping, sexual sphere, social sphere, and traveling. At the end of the assessment, a percentage is assigned where 100% expresses the absence of limitations in performing daily activities. The further away from the maximum threshold, the greater the degree of disability the patient experiences.
Measured: at baseline (day 0)
Owestry Disability Index (ODI)
The ODI score is a scorecard on daily activities and the degree of limitation experienced by the patient with low back pain.
The form consists of 10 multiple-choice questions (5 options) regarding different aspects of daily life such as pain intensity, personal care, walking, climbing stairs, standing up, sleeping, sexual sphere, social sphere, and traveling. At the end of the assessment, a percentage is assigned where 100% expresses the absence of limitations in performing daily activities. The further away from the maximum threshold, the greater the degree of disability the patient experiences.
Measured: after 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start20 Jan 2022
- Primary completion1 Feb 2025
- Study completion10 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Superior Cluneal Nerve EntrapmentStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059612
- Sponsor's protocol ID
- CLU-1
- Status last verified
- Dec 2025
- First submitted
- 22 Sep 2023
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kuniya H, Aota Y, Kawai T, Kaneko K, Konno T, Saito T. Prospective study of superior cluneal nerve disorder as a potential cause of low back pain and leg symptoms. J Orthop Surg Res. 2014 Dec 31;9:139. doi: 10.1186/s13018-014-0139-7.
PubMed 25551470Morimoto D, Isu T, Kim K, Chiba Y, Iwamoto N, Isobe M, Morita A. Long-term Outcome of Surgical Treatment for Superior Cluneal Nerve Entrapment Neuropathy. Spine (Phila Pa 1976). 2017 May 15;42(10):783-788. doi: 10.1097/BRS.0000000000001913.
PubMed 27669049Bodner G, Platzgummer H, Meng S, Brugger PC, Gruber GM, Lieba-Samal D. Successful Identification and Assessment of the Superior Cluneal Nerves with High-Resolution Sonography. Pain Physician. 2016 Mar;19(3):197-202.
PubMed 27008294
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Upper Cluneal Nerve Entrapment Syndrome for Reduction of Low Back Pain: Single-arm Experimental Study
- ClinicalTrials.gov ID
- NCT06059612
- Acronym / sponsor ID
- CLU-1
- Conditions
- Superior Cluneal Nerve Entrapment
- Keywords
- Superior cluneal nerve, nerve entrapment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 10 Feb 2025 (actual)
- First posted
- 28 Sep 2023 (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.
Superior cluneal nerve entrapment (SCN) is a painful symptomatic condition related to compression by the thoracolumbar and gluteal bands of nerve outcrop, above the iliac crest. This syndrome is not considered in the classical differential diagnosis of lumbosacral spine disorders and is almost unknown in Italy.
It is a neuropathic pain, acute, subacute, or chronic, evoked by mechanical stress at the level of the sensory territory corresponding to the superior cluneal nerve, easily found anatomically and evoked at a trigger point on the posterior iliac crest approximately 70mm from the midline and 45mm from the posterior superior iliac spine.
SCN entrapment syndrome represents a not so infrequent syndrome. It is easily framed and treatment is effective in most cases. Therefore, diagnosis and treatment of this syndrome represents an excellent option in all those patients with low back pain that cannot be otherwise framed and resolved.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Procedure: injectionSuperior cluneal nerve entrapment (SCN) will be treated with local steroid injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with age between 18 and 99 years
- male and female sex
- superior cluneal nerve trigger point positivity at clinical evaluation
- absence of urgent criteria for spinal surgery
Key exclusion criteria (5 listed)
- patients younger than 18 years old
- patients who have not given consent to be included in the study
- patients with negative upper cluneal nerve trigger point - emergency criteria for spine surgery
- pregnant women - patients allergic to local anesthetic
- patients with language barrier
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 |
|---|---|---|
| injectionsteroid injection into superior cluneal nerve | Procedure or surgery | Experimental |
Primary outcome
numerical rating scale (NRS)
Time frame: at baseline (day 0)
NRS is a numerical scale for assessing pain exclusively. It is precisely a numerical scale ranging from 0 to 10 where the degree of pain perceived by the patient is expressed in an increasing manner. The value 0 corresponds to the 'absence of pain, the valor
numerical rating scale (NRS)
Time frame: after 45 days
NRS is a numerical scale for assessing pain exclusively. It is precisely a numerical scale ranging from 0 to 10 where the degree of pain perceived by the patient is expressed in an increasing manner. The value 0 corresponds to the 'absence of pain, the valor
Owestry Disability Index (ODI)
Time frame: at baseline (day 0)
The ODI score is a scorecard on daily activities and the degree of limitation experienced by the patient with low back pain. The form consists of 10 multiple-choice questions (5 options) regarding different aspects of daily life such as pain intensity, personal care, walking, climbing stairs, standing up, sleeping, sexual sphere, social sphere, and traveling. At the end of the assessment, a percentage is assigned where 100% expresses the absence of limitations in performing daily activities. The further away from the maximum threshold, the greater the degree of disability the patient experiences.
Owestry Disability Index (ODI)
Time frame: after 45 days
The ODI score is a scorecard on daily activities and the degree of limitation experienced by the patient with low back pain. The form consists of 10 multiple-choice questions (5 options) regarding different aspects of daily life such as pain intensity, personal care, walking, climbing stairs, standing up, sleeping, sexual sphere, social sphere, and traveling. At the end of the assessment, a percentage is assigned where 100% expresses the absence of limitations in performing daily activities. The further away from the maximum threshold, the greater the degree of disability the patient experiences.
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 30 Dec 2025.
- Results publication: PubMed 25551470Kuniya H, Aota Y, Kawai T, Kaneko K, Konno T, Saito T. Prospective study of superior cluneal nerve disorder as a potential cause of low back pain and leg symptoms. J Orthop Surg Res. 2014 Dec 31;9:139. doi: 10.1186/s13018-014-0139-7.
- Results publication: PubMed 27669049Morimoto D, Isu T, Kim K, Chiba Y, Iwamoto N, Isobe M, Morita A. Long-term Outcome of Surgical Treatment for Superior Cluneal Nerve Entrapment Neuropathy. Spine (Phila Pa 1976). 2017 May 15;42(10):783-788. doi: 10.1097/BRS.0000000000001913.
- Results publication: PubMed 27008294Bodner G, Platzgummer H, Meng S, Brugger PC, Gruber GM, Lieba-Samal D. Successful Identification and Assessment of the Superior Cluneal Nerves with High-Resolution Sonography. Pain Physician. 2016 Mar;19(3):197-202.
- Individual participant dataSharing planned: No
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RecruitingObservational study
Proximal Versus Distal Superior Cluneal Nerve Block in Entrapment Neuropathy
Cluneal Syndrome
Enrolling by invitation
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing injection in people with Superior Cluneal Nerve Entrapment, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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 5 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 30 Dec 2025. 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 Italy. 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?
numerical rating scale (NRS) (time frame: at baseline (day 0)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06059612, which also lists 3 linked publications.
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 30 Dec 2025.