Superior Cluneal Nerve EntrapmentPRO-SCNNCT07712406
Ultrasound-Guided Proximal Superior Cluneal Nerve Block for Superior Cluneal Nerve Entrapment
An observational study of Superior Cluneal Nerve Entrapment and Chronic Low Back Pain, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Superior cluneal nerve entrapment (SCNE) is an underrecognized cause of chronic low back pain and gluteal pain that may mimic lumbar spine disorders. Ultrasound-guided proximal superior cluneal nerve block has increasingly been used in routine clinical practice .Diagnostic superior cluneal nerve block is commonly used… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Superior Cluneal Nerve Entrapment, Chronic Low Back Pain
- What is being tested?
- Ultrasound-Guided Proximal Superior Cluneal Nerve Block
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2026to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with chronic low back and/or gluteal pain and a positive diagnostic superior cluneal nerve block response who undergo ultrasound-guided proximal superior cluneal nerve block as part of routine clinical care. Participants will be prospectively followed for clinical outcomes.
Who may be able to join
- Age 18-75 years.
- Chronic low back and/or gluteal pain persisting for at least 3 months.
- Localized pain and/or tenderness over the posterior iliac crest.
- At least 50% reduction in pain intensity following diagnostic superior cluneal nerve block.
- Failure of conservative treatment.
- Ability to provide written informed consent.
Who cannot join
- Previous superior cluneal nerve surgery.
- Active local or systemic infection.
- Bleeding disorders or contraindications to the procedure.
- Allergy to study medications.
- Pregnancy.
- Severe cognitive impairment or inability to complete study assessments.
- Additional interventional pain procedures involving the affected region during follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tuğba Bayraktar Çelebioğlu, Medical Doctor contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gaziosmanpasa Research and Education Hospital
Gaziosmanpaşa, Istanbul, 34255
Tuğçe Yavuz Mollavelioğlu, Medical Doctor, +905056751666, tugceyavuz@hotmail.com.tr
About this study
Official title: Clinical Outcomes of Ultrasound-Guided Proximal Superior Cluneal Nerve Block in Patients With Superior Cluneal Nerve Entrapment
Superior cluneal nerve entrapment (SCNE) is an underrecognized cause of chronic low back pain and gluteal pain that may mimic lumbar spine disorders. Ultrasound-guided proximal superior cluneal nerve block has increasingly been used in routine clinical practice .Diagnostic superior cluneal nerve block is commonly used to confirm the diagnosis, whereas ultrasound-guided proximal superior cluneal nerve block has emerged as a therapeutic option.
This prospective observational cohort study aims to evaluate the clinical outcomes of ultrasound-guided proximal superior cluneal nerve block in patients with clinically diagnosed superior cluneal nerve entrapment who undergo the procedure as part of routine clinical care. Pain intensity, disability, and neuropathic pain characteristics will be assessed at baseline and during follow-up to evaluate treatment outcomes.
Read the detailed description
Superior cluneal nerve entrapment (SCNE) is an increasingly recognized cause of chronic low back pain that may be overlooked or misdiagnosed as lumbar radiculopathy or other degenerative lumbar disorders. Accurate diagnosis is essential because patients with SCNE may benefit from targeted peripheral nerve interventions rather than treatments directed at the lumbar spine.
Ultrasound-guided proximal superior cluneal nerve block has emerged as a practical technique for both diagnostic confirmation and therapeutic management of SCNE. Compared with landmark-based approaches, ultrasound guidance enables real-time visualization of relevant anatomical structures and standardized needle placement. Despite increasing clinical use, prospective evidence evaluating the clinical outcomes of this technique remains limited.
This prospective observational cohort study will enroll patients with clinically diagnosed superior cluneal nerve entrapment who undergo ultrasound-guided proximal superior cluneal nerve block as part of routine clinical care. Pain intensity, disability, and neuropathic pain characteristics will be evaluated at baseline and at 1- and 3-month follow-up visits using validated clinical outcome measures.
The primary objective is to evaluate changes in pain intensity following ultrasound-guided proximal superior cluneal nerve block. Secondary objectives include evaluating changes in disability and neuropathic pain characteristics after treatment and documenting the clinical outcomes of this intervention during routine practice.
- Being tested
- Ultrasound-Guided Proximal Superior Cluneal Nerve Block
- Keywords
- Superior Cluneal Nerve Entrapment, Ultrasound-Guided Nerve Block, Chronic Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Proximal Superior Cluneal Nerve BlockProcedure or surgery
Ultrasound-guided proximal superior cluneal nerve block will be performed as part of routine clinical care in patients with clinically diagnosed superior cluneal nerve entrapment. The proximal superior cluneal nerve will be targeted using a standardized ultrasound-guided interfascial technique. A standardized injectate will be administered according to the study protocol. All procedures will be performed by an experienced pain physician using the same technique for all participants.
| Study group | Role | What they receive |
|---|---|---|
| Patients With Superior Cluneal Nerve Entrapment Undergoing Ultrasound-Guided Proximal Superior Clune | Adults with clinically diagnosed superior cluneal nerve entrapment undergoing ultrasound-guided proximal superior cluneal nerve block as part of routine clinical care. Participants will undergo baseline clinical assessment followed by follow-up evaluations at 1 and 3 months. Receives: Procedure: Ultrasound-Guided Proximal Superior Cluneal Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity
Pain intensity will be assessed using the 11-point Numeric Rating Scale (NRS), a unidimensional pain assessment tool ranging from 0 (no pain) to 10 (the worst imaginable/unbearable pain). Patients will be asked to select the number that best reflects their pain intensity. The change in NRS pain score following ultrasound-guided proximal superior cluneal nerve block will be evaluated at the predefined follow-up time points.
Measured: Baseline, 1 month, and 3 months
Secondary outcomes (3)
Change in Oswestry Disability Index (ODI) Score
Oswestry Disability Index (ODI): Change in disability related to low back pain assessed using the Oswestry Disability Index (ODI).The validated and reliability-tested Turkish version of the ODI will be used in this study.The ODI consists of 10 items, each scored from 0 to 5, yielding a maximum total raw score of 50.The total score is converted to a percentage using the following formula:ODI percentage = (Total score / 50) × 100
Higher percentage scores indicate greater disability. Disability levels are interpreted as follows:
0-20%: Minimal disability 21-40%: Moderate disability 41-60%: Severe disability 61-80%: Crippling disability 81-100%: Bed-bound or exaggerated symptoms A decrease in ODI percentage score indicates improvement in functional status. The change in ODI score following ultrasound-guided proximal superior cluneal nerve block will be evaluated at the predefined follow-up time points.
Measured: Baseline, 1 month, and 3 months
Douleur Neuropathique 4 (DN4)
Neuropathic pain will be assessed using the Douleur Neuropathique en 4 Questions (DN4) questionnaire, a validated 10-item screening tool with scores ranging from 0 to 10, where higher scores indicate a greater likelihood of neuropathic pain and a score of ≥4 is considered indicative of neuropathic pain. The change in DN4 score following ultrasound-guided proximal superior cluneal nerve block will be evaluated at the predefined follow-up time points.
Measured: Baseline, 1 month, and 3 months
Treatment Response
Treatment response will be defined as a ≥50% reduction in NRS pain score compared with baseline.
Measured: 1 month and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start15 May 2026
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07712406
- Sponsor's protocol ID
- MEDIPOL-EC-846-2026
- Acronym
- PRO-SCN
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators have not yet made a final decision regarding individual participant data (IPD) sharing. Data sharing will be considered after study completion in accordance with institutional policies, ethical requirements, and applicable data protection regulations.
Publications
Bodner 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 27008294Luo X, Zhao Y. Ultrasound-Guided Superior Cluneal Nerve Block: A Narrative Review. J Pain Res. 2024 May 22;17:1829-1836. doi: 10.2147/JPR.S462166. eCollection 2024.
PubMed 38799273Nielsen TD, Moriggl B, Barckman J, Jensen JM, Kolsen-Petersen JA, Soballe K, Borglum J, Bendtsen TF. Randomized trial of ultrasound-guided superior cluneal nerve block. Reg Anesth Pain Med. 2019 May 6:rapm-2018-100174. doi: 10.1136/rapm-2018-100174. Online ahead of print.
PubMed 31061111
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Ultrasound-Guided Proximal Superior Cluneal Nerve Block in Patients With Superior Cluneal Nerve Entrapment
- ClinicalTrials.gov ID
- NCT07712406
- Acronym / sponsor ID
- PRO-SCN / MEDIPOL-EC-846-2026
- Keywords
- Superior Cluneal Nerve Entrapment, Ultrasound-Guided Nerve Block, Chronic Low Back Pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 15 May 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Jul 2026 (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 (SCNE) is an underrecognized cause of chronic low back pain and gluteal pain that may mimic lumbar spine disorders. Ultrasound-guided proximal superior cluneal nerve block has increasingly been used in routine clinical practice .Diagnostic superior cluneal nerve block is commonly used to confirm the diagnosis, whereas ultrasound-guided proximal superior cluneal nerve block has emerged as a therapeutic option.
This prospective observational cohort study aims to evaluate the clinical outcomes of ultrasound-guided proximal superior cluneal nerve block in patients with clinically diagnosed superior cluneal nerve entrapment who undergo the procedure as part of routine clinical care. Pain intensity, disability, and neuropathic pain characteristics will be assessed at baseline and during follow-up to evaluate treatment outcomes.
Detailed description
Superior cluneal nerve entrapment (SCNE) is an increasingly recognized cause of chronic low back pain that may be overlooked or misdiagnosed as lumbar radiculopathy or other degenerative lumbar disorders. Accurate diagnosis is essential because patients with SCNE may benefit from targeted peripheral nerve interventions rather than treatments directed at the lumbar spine.
Ultrasound-guided proximal superior cluneal nerve block has emerged as a practical technique for both diagnostic confirmation and therapeutic management of SCNE. Compared with landmark-based approaches, ultrasound guidance enables real-time visualization of relevant anatomical structures and standardized needle placement. Despite increasing clinical use, prospective evidence evaluating the clinical outcomes of this technique remains limited.
This prospective observational cohort study will enroll patients with clinically diagnosed superior cluneal nerve entrapment who undergo ultrasound-guided proximal superior cluneal nerve block as part of routine clinical care. Pain intensity, disability, and neuropathic pain characteristics will be evaluated at baseline and at 1- and 3-month follow-up visits using validated clinical outcome measures.
The primary objective is to evaluate changes in pain intensity following ultrasound-guided proximal superior cluneal nerve block. Secondary objectives include evaluating changes in disability and neuropathic pain characteristics after treatment and documenting the clinical outcomes of this intervention during routine practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients With Superior Cluneal Nerve Entrapment Undergoing Ultrasound-Guided Proximal Superior Clune | – | Procedure: Ultrasound-Guided Proximal Superior Cluneal Nerve BlockAdults with clinically diagnosed superior cluneal nerve entrapment undergoing ultrasound-guided proximal superior cluneal nerve block as part of routine clinical care. Participants will undergo baseline clinical assessment followed by follow-up evaluations at 1 and 3 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with chronic low back and/or gluteal pain and a positive diagnostic superior cluneal nerve block response who undergo ultrasound-guided proximal superior cluneal nerve block as part of routine clinical care. Participants will be prospectively followed for clinical outcomes.
Key inclusion criteria (6 listed)
- Age 18-75 years.
- Chronic low back and/or gluteal pain persisting for at least 3 months.
- Localized pain and/or tenderness over the posterior iliac crest.
- At least 50% reduction in pain intensity following diagnostic superior cluneal nerve block.
- Failure of conservative treatment.
Key exclusion criteria (7 listed)
- Previous superior cluneal nerve surgery.
- Active local or systemic infection.
- Bleeding disorders or contraindications to the procedure.
- Allergy to study medications.
- Pregnancy.
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 Proximal Superior Cluneal Nerve BlockUltrasound-guided proximal superior cluneal nerve block will be performed as part of routine clinical care in patients with clinically diagnosed superior cluneal nerve entrapment. The proximal superior cluneal nerve will be targeted using a standardized ultrasound-guided interfascial technique. A standardized injectate will be administered according to the study protocol. All procedures will be performed by an experienced pain physician using the same technique for all participants. | Procedure or surgery | Patients With Superior Cluneal Nerve Entrapment Undergoing Ultrasound-Guided Proximal Superior Clune |
Primary outcome
Change in Pain Intensity
Time frame: Baseline, 1 month, and 3 months
Pain intensity will be assessed using the 11-point Numeric Rating Scale (NRS), a unidimensional pain assessment tool ranging from 0 (no pain) to 10 (the worst imaginable/unbearable pain). Patients will be asked to select the number that best reflects their pain intensity. The change in NRS pain score following ultrasound-guided proximal superior cluneal nerve block will be evaluated at the predefined follow-up time points.
3 secondary outcomes
Change in Oswestry Disability Index (ODI) Score
Time frame: Baseline, 1 month, and 3 months
Douleur Neuropathique 4 (DN4)
Time frame: Baseline, 1 month, and 3 months
Treatment Response
Time frame: 1 month and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- 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.
- Results publication: PubMed 38799273Luo X, Zhao Y. Ultrasound-Guided Superior Cluneal Nerve Block: A Narrative Review. J Pain Res. 2024 May 22;17:1829-1836. doi: 10.2147/JPR.S462166. eCollection 2024.
- Results publication: PubMed 31061111Nielsen TD, Moriggl B, Barckman J, Jensen JM, Kolsen-Petersen JA, Soballe K, Borglum J, Bendtsen TF. Randomized trial of ultrasound-guided superior cluneal nerve block. Reg Anesth Pain Med. 2019 May 6:rapm-2018-100174. doi: 10.1136/rapm-2018-100174. Online ahead of print.
- Individual participant dataSharing planned: Undecided. The investigators have not yet made a final decision regarding individual participant data (IPD) sharing. Data sharing will be considered after study completion in accordance with institutional policies, ethical requirements, and applicable data protection regulations.
Related trials for Superior Cluneal Nerve Entrapment
RecruitingObservational study
Proximal Versus Distal Superior Cluneal Nerve Block in Entrapment Neuropathy
Cluneal Syndrome
Enrolling by invitation
Peng's "Fenjin Tuina" for Superior Cluneal Nerve Entrapment Syndrome: A Prospective, Randomized, Single-center Trial
SCNES, Superior Cluneal Nerve Entrapment Syndrome
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.
Tuğba Bayraktar Çelebioğlu, Medical Doctor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Superior Cluneal Nerve Entrapment and Chronic Low Back Pain, run by Gaziosmanpasa Research and Education Hospital 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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 28 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tuğçe Yavuz Mollavelioğlu, Medical Doctor (+905056751666, tugceyavuz@hotmail.com.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity (time frame: Baseline, 1 month, and 3 months). 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 NCT07712406, 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 28 Jul 2026.