Cluneal SyndromeNCT07372430
Proximal Versus Distal Superior Cluneal Nerve Block in Entrapment Neuropathy
An observational study of Cluneal Syndrome, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Superior cluneal nerve (SCN) entrapment is an underdiagnosed cause of chronic low back and gluteal pain. Although diagnostic nerve block is considered the gold standard for confirming SCN entrapment, there is no consensus regarding the optimal injection approach. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cluneal Syndrome
- What is being tested?
- Ultrasound-guided distal superior cluneal nerve injection and Ultrasound-guided proximal superior cluneal nerve injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Dec 2025to 1 Aug 2026
- How long will I take part?
- 3 Months
- 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: The study population will consist of adult patients aged 18 to 75 years presenting with chronic low back and/or gluteal pain lasting longer than three months, who are clinically suspected of having superior cluneal nerve entrapment based on physical examination findings. Eligible participants will be those who have not responded to conservative treatment and who attend the Algology Outpatient Clinic during the study period. Only patients with unilateral symptoms who meet all inclusion and exclusion criteria and who provide written informed consent will be included in the study.
Who may be able to join
- Age between 18 and 75 years
- Chronic low back and/or gluteal pain lasting longer than 3 months
- Localized point tenderness and/or paresthesia on palpation over the unilateral posterior iliac crest
- Clinical suspicion of superior cluneal nerve entrapment based on physical examination
- Failure to respond to conservative treatment
- Ability and willingness to provide written informed consent
Who cannot join
- Active local or systemic infection
- Cognitive impairment or psychiatric disorders interfering with study participation
- History of malignancy or cancer-related pain
- Uncontrolled diabetes mellitus or severe comorbid conditions adversely affecting general health
- Pregnancy
- Known allergy to the medications used in the injection
Show all 12Show fewer
- Prominent radicular pain associated with neurological deficit
- History of interventional procedures applied to the lumbar region within the last 6 months
- Initiation of another lumbar interventional or medical treatment during the follow-up period
- Suspected bilateral superior cluneal nerve entrapment
- Sphincter dysfunction related to neurological disease
- Bleeding diathesis or coagulation disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Health Sciences University Gaziosmanpaşa Physical Medicine and Rehabilitation Training and Research Hospita
Istanbul, 34255
Tugba Bayraktar Celebioglu, MD, +905444720367, t.byrktr@hotmail.com
Tugce Yavuz Mollavelioglu, MD, +905056751666, tugceyavuz@hotmail.com.tr
About this study
Official title: Proximal Versus Distal Superior Cluneal Nerve Block in Superior Cluneal Nerve Entrapment: A Prospective, Randomized, Single-Blind Trial
Superior cluneal nerve (SCN) entrapment is an underdiagnosed cause of chronic low back and gluteal pain. Although diagnostic nerve block is considered the gold standard for confirming SCN entrapment, there is no consensus regarding the optimal injection approach. This prospective observational study aims to compare the clinical effectiveness of proximal and distal ultrasound-guided SCN block techniques in patients diagnosed with SCN entrapment. Pain intensity and functional outcomes will be evaluated over the follow-up period to assess differences between the two approaches.
Read the detailed description
The primary objective of this study is to compare the effects of two different ultrasound-guided injection techniques on pain intensity, functional status, neuropathic pain components, and quality of life in patients with suspected superior cluneal nerve (SCN) entrapment. Pain severity will be assessed using the Visual Analog Scale (VAS), functional status using the Oswestry Disability Index (ODI), neuropathic pain components using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS), and quality of life using the Short Form-12 (SF-12). The study aims to determine which injection technique provides superior clinical outcomes.
The secondary objective is to evaluate lumbosacral angle, lumbar lordosis angle, pelvic tilt, sacral tilt, and the presence of scoliosis, and to investigate the relationship between these postural and radiological parameters, SCN entrapment, and treatment response.
Through this study, ultrasound-guided injection techniques used in the diagnosis and treatment of SCN entrapment will be comparatively evaluated, addressing an important gap in the current literature and providing high-level scientific evidence to guide clinicians in the management of chronic low back and gluteal pain.
This study is designed as a prospective, randomized, single-blind clinical study comparing two different ultrasound-guided injection techniques in patients with suspected superior cluneal nerve entrapment. The study population will consist of patients presenting to the Algology Outpatient Clinic of Health Sciences University Gaziosmanpaşa Physical Medicine and Rehabilitation Training and Research Hospital during the study period, who meet the inclusion and exclusion criteria, have chronic low back and/or gluteal pain, are suspected of having SCN entrapment based on clinical examination, have not benefited from conservative treatment, and voluntarily agree to participate in the study.
Based on a power analysis with 95% power, a total of 54 patients are planned to be included in the study, with 27 patients allocated to each group.
- Conditions
- Cluneal Syndrome
- Being tested
- Ultrasound-guided distal superior cluneal nerve injection, Ultrasound-guided proximal superior cluneal nerve injection
- Keywords
- Neuralgia, Peripheral Nerve Entrapment, low back pain
- Medical subject headings
- Neuralgia, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided distal superior cluneal nerve injectionProcedure or surgery
The ultrasound probe will be placed over the posterior superior iliac crest to visualize the fibro-osseous tunnel where the superior cluneal nerve passes. Using an in-plane approach, the needle will be advanced toward the target area, and the injection will be administered at the fascial exit point of the nerve. A total injectate volume of 5 cc (2 cc bupivacaine, 2 cc dexamethasone, and 1 cc normal saline) will be administered. All procedures will be performed in the prone position under standard aseptic conditions.
Ultrasound-guided proximal superior cluneal nerve injectionProcedure or surgery
Patients randomized to the proximal injection group will undergo ultrasound-guided injection above the iliac crest level. The target will be the plane beneath the posterior layer of the thoracolumbar fascia. Using an in-plane approach, the injectate will be delivered into the interfascial plane. A total injectate volume of 5 cc (2 cc bupivacaine, 2 cc dexamethasone, and 1 cc normal saline) will be administered under ultrasound guidance. Patient positioning and aseptic conditions will be identical to those used in the distal perineural injection group.
| Study group | Role | What they receive |
|---|---|---|
| Proximal SCN Injection (Ultrasound-Guided) | Ultrasound-guided proximal interfascial (plane block) approach for suspected superior cluneal nerve entrapment. Receives: Procedure: Ultrasound-guided proximal superior cluneal nerve injection | |
| Distal SCN Injection (Ultrasound-Guided) | Ultrasound-guided distal perineural approach for suspected superior cluneal nerve entrapment. Receives: Procedure: Ultrasound-guided distal superior cluneal nerve injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Primary Outcome Measure Visual Analog Scale for Pain (VAS): Change in pain intensity assessed using the Visual Analog Scale (VAS).The VAS is a 10-cm horizontal scale ranging from 0 (no pain) to 10 (worst imaginable pain).Higher scores indicate greater pain intensity, and a reduction in VAS score represents clinical improvement.
Measured: Baseline, 1 month, and 3 months
Secondary outcomes (4)
Oswestry Disability Index (ODI)
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.
Measured: Baseline, 1 month, and 3 months
Leeds Assessment of Neuropathic Symptoms and Signs (LANSS)
Assessment of neuropathic pain features using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) questionnaire.The LANSS scale consists of 7 items with a total score ranging from 0 to 24.A score of ≥12 indicates the presence of neuropathic pain mechanisms.Higher scores reflect greater neuropathic pain components.
Measured: Baseline, 1 month, and 3 months
Short Form-12 Health Survey (SF-12)
Health-related quality of life assessed using the Short Form-12 Health Survey (SF-12).The SF-12 generates two composite scores:
- Physical Component Summary (PCS)
- Mental Component Summary (MCS) Both PCS and MCS scores are calculated according to standard scoring algorithms.Higher scores indicate better physical and mental health-related quality of life, respectively.In this study, PCS and MCS scores will be analyzed separately to evaluate physical and mental aspects of quality of life.
Measured: Baseline, 1 month, and 3 months
Baseline Postural and Radiological Characteristics in Patients with Superior Cluneal Nerve Entrapment
Baseline postural and radiological characteristics will be assessed prior to intervention in patients with superior cluneal nerve entrapment. Previously obtained standing lateral lumbosacral and pelvic radiographs will be used. Lumbar lordosis, sacral slope, lumbosacral angle, and pelvic tilt will be measured as radiographic angles in degrees on standing lateral images and categorized as decreased/normal/increased (lumbar lordosis, sacral slope, lumbosacral angle) or anterior/normal/posterior (pelvic tilt). Scoliosis will be evaluated based on physical examination and review of existing radiographs and MRI scans; when clinically indicated, standing scoliosis radiographs will be obtained. Scoliosis will be assessed using the Cobb method and recorded as present or absent. These findings will be descriptively reported.
Measured: Baseline (pre-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start12 Dec 2025
- Primary completion1 Jul 2026
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cluneal SyndromeStudies 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
- 54 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Tugce Yavuz Mollavelioglu, MD, Study chair, Gaziosmanapasa Educational and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372430
- Sponsor's protocol ID
- 1496
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional data protection policies and the absence of participant consent for data sharing beyond the scope of the current study.
Publications
Nielsen 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 31061111Bodner 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 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proximal Versus Distal Superior Cluneal Nerve Block in Superior Cluneal Nerve Entrapment: A Prospective, Randomized, Single-Blind Trial
- ClinicalTrials.gov ID
- NCT07372430
- Acronym / sponsor ID
- 1496
- Conditions
- Cluneal Syndrome
- Keywords
- Neuralgia, Peripheral Nerve Entrapment, low back pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 28 Jan 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 (SCN) entrapment is an underdiagnosed cause of chronic low back and gluteal pain. Although diagnostic nerve block is considered the gold standard for confirming SCN entrapment, there is no consensus regarding the optimal injection approach. This prospective observational study aims to compare the clinical effectiveness of proximal and distal ultrasound-guided SCN block techniques in patients diagnosed with SCN entrapment. Pain intensity and functional outcomes will be evaluated over the follow-up period to assess differences between the two approaches.
Detailed description
The primary objective of this study is to compare the effects of two different ultrasound-guided injection techniques on pain intensity, functional status, neuropathic pain components, and quality of life in patients with suspected superior cluneal nerve (SCN) entrapment. Pain severity will be assessed using the Visual Analog Scale (VAS), functional status using the Oswestry Disability Index (ODI), neuropathic pain components using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS), and quality of life using the Short Form-12 (SF-12). The study aims to determine which injection technique provides superior clinical outcomes.
The secondary objective is to evaluate lumbosacral angle, lumbar lordosis angle, pelvic tilt, sacral tilt, and the presence of scoliosis, and to investigate the relationship between these postural and radiological parameters, SCN entrapment, and treatment response.
Through this study, ultrasound-guided injection techniques used in the diagnosis and treatment of SCN entrapment will be comparatively evaluated, addressing an important gap in the current literature and providing high-level scientific evidence to guide clinicians in the management of chronic low back and gluteal pain.
This study is designed as a prospective, randomized, single-blind clinical study comparing two different ultrasound-guided injection techniques in patients with suspected superior cluneal nerve entrapment. The study population will consist of patients presenting to the Algology Outpatient Clinic of Health Sciences University Gaziosmanpaşa Physical Medicine and Rehabilitation Training and Research Hospital during the study period, who meet the inclusion and exclusion criteria, have chronic low back and/or gluteal pain, are suspected of having SCN entrapment based on clinical examination, have not benefited from conservative treatment, and voluntarily agree to participate in the study.
Based on a power analysis with 95% power, a total of 54 patients are planned to be included in the study, with 27 patients allocated to each group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proximal SCN Injection (Ultrasound-Guided) | – | Procedure: Ultrasound-guided proximal superior cluneal nerve injectionUltrasound-guided proximal interfascial (plane block) approach for suspected superior cluneal nerve entrapment. |
| Distal SCN Injection (Ultrasound-Guided) | – | Procedure: Ultrasound-guided distal superior cluneal nerve injectionUltrasound-guided distal perineural approach for suspected superior cluneal nerve entrapment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients aged 18 to 75 years presenting with chronic low back and/or gluteal pain lasting longer than three months, who are clinically suspected of having superior cluneal nerve entrapment based on physical examination findings. Eligible participants will be those who have not responded to conservative treatment and who attend the Algology Outpatient Clinic during the study period. Only patients with unilateral symptoms who meet all inclusion and exclusion criteria and who provide written informed consent will be included in the study.
Key inclusion criteria (6 listed)
- Age between 18 and 75 years
- Chronic low back and/or gluteal pain lasting longer than 3 months
- Localized point tenderness and/or paresthesia on palpation over the unilateral posterior iliac crest
- Clinical suspicion of superior cluneal nerve entrapment based on physical examination
- Failure to respond to conservative treatment
Key exclusion criteria (12 listed)
- Active local or systemic infection
- Cognitive impairment or psychiatric disorders interfering with study participation
- History of malignancy or cancer-related pain
- Uncontrolled diabetes mellitus or severe comorbid conditions adversely affecting general health
- 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 distal superior cluneal nerve injectionThe ultrasound probe will be placed over the posterior superior iliac crest to visualize the fibro-osseous tunnel where the superior cluneal nerve passes. Using an in-plane approach, the needle will be advanced toward the target area, and the injection will be administered at the fascial exit point of the nerve. A total injectate volume of 5 cc (2 cc bupivacaine, 2 cc dexamethasone, and 1 cc normal saline) will be administered. All procedures will be performed in the prone position under standard aseptic conditions. | Procedure or surgery | Distal SCN Injection (Ultrasound-Guided) |
| Ultrasound-guided proximal superior cluneal nerve injectionPatients randomized to the proximal injection group will undergo ultrasound-guided injection above the iliac crest level. The target will be the plane beneath the posterior layer of the thoracolumbar fascia. Using an in-plane approach, the injectate will be delivered into the interfascial plane. A total injectate volume of 5 cc (2 cc bupivacaine, 2 cc dexamethasone, and 1 cc normal saline) will be administered under ultrasound guidance. Patient positioning and aseptic conditions will be identical to those used in the distal perineural injection group. | Procedure or surgery | Proximal SCN Injection (Ultrasound-Guided) |
Primary outcome
Visual Analog Scale (VAS)
Time frame: Baseline, 1 month, and 3 months
Primary Outcome Measure Visual Analog Scale for Pain (VAS): Change in pain intensity assessed using the Visual Analog Scale (VAS).The VAS is a 10-cm horizontal scale ranging from 0 (no pain) to 10 (worst imaginable pain).Higher scores indicate greater pain intensity, and a reduction in VAS score represents clinical improvement.
4 secondary outcomes
Oswestry Disability Index (ODI)
Time frame: Baseline, 1 month, and 3 months
Leeds Assessment of Neuropathic Symptoms and Signs (LANSS)
Time frame: Baseline, 1 month, and 3 months
Short Form-12 Health Survey (SF-12)
Time frame: Baseline, 1 month, and 3 months
Baseline Postural and Radiological Characteristics in Patients with Superior Cluneal Nerve Entrapment
Time frame: Baseline (pre-intervention)
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 15 Jul 2026.
- Background: 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.
- Background: 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. Individual participant data will not be shared due to institutional data protection policies and the absence of participant consent for data sharing beyond the scope of the current study.
Related trials for Cluneal Syndrome
RecruitingObservational study
Decompression of Pudendal and Inferior Cluneal Nerves Using Robot-assisted Laparoscopy for Entrapment Neuralgias : the X-DECO Study
Pudendal Neuralgia
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
RecruitingObservational study
Perioperative Medical Program to Optimize Nerve Regeneration After Robot-assisted Laparoscopic Neurolyses of Pudendal and/or Inferior Cluneal Nerves for Chronic Neuralgias: Results After 1-year Follow-up
Pudendal Neuralgia, Neuralgia
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.
Tugce Yavuz Mollavelioglu, MD study chair
Gaziosmanapasa Educational and Training Hospital
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 Cluneal Syndrome, 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 12 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 15 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 Tugce Yavuz Mollavelioglu, M.D (+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?
Visual Analog Scale (VAS) (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 NCT07372430, which also lists 2 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 15 Jul 2026.