Cluneal SyndromeNCT05423132
Study on the Efficacy of Infiltration of Upper Cluneal Nerves in Chronic Pain Related to Cluneal Syndrome
A study testing Ropivacaine injection and Physiological serum injection in people with Cluneal Syndrome and Nerve Entrapment Syndrome, run by Centre Hospitalier Universitaire Saint Pierre.
Trial summary
Lower back pain is a very common complaint in the Chronic Pain Clinic. Its etiology is nonspecific in 85% of the cases. In 1957, Strong and Davila reported that the superior cluneal nerves (SCNs) and middle cluneal nerves (MCNs) can be entrapped around the iliac crest, suggesting a causal relationship between this… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cluneal Syndrome, Nerve Entrapment Syndrome
- What is being tested?
- Ropivacaine injection and Physiological serum injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient signed Inform Consent
- Patient diagnosed with unilateral or bilateral superior cluneal syndrome :
- Diagnostic points will be :
- a maximum pain at the trigger point on the back iliac crest, approximately 7 cm from the median line and 4.5 cm from the poster superior iliac crest. Palpation on this point causes pain reminding the patient's long-term pain),
- Palpation "rolled-palpated" at the buttocks provokes either pain, paraesthesia, or discomfort.
- The criteria of facial syndrome, sacro-iliac syndrome or radiculopathy are excluded.
- Low back pain during back movements.
Who cannot join
- Pain not associated to superior cluneal syndrome.
- Infection at the puncture point.
- Pain of suspected neoplastic origin.
- Allergy to local anaesthetics.
- Refusal of the patient
About this study
Lower back pain is a very common complaint in the Chronic Pain Clinic. Its etiology is nonspecific in 85% of the cases. In 1957, Strong and Davila reported that the superior cluneal nerves (SCNs) and middle cluneal nerves (MCNs) can be entrapped around the iliac crest, suggesting a causal relationship between this entrapment (SCN-Entrapment, SCN-E) and low back pain symptom. This is known today as "cluneal syndrome".
Cluneal syndrome remains poorly investigated and is currently a diagnostic challenge. Various types of lumbar movements exacerbate its occurence. The most common theory regarding the origin of this pain evokes that is primarily due to a mechanical cause linked to stenosis or adhesions of fibrous tissue around the cluneal nerves causing distress.
Read more
The hypothesis is that the investigator can reduce the pain related to the syndrome of superior cluneal origin thanks to a "volume effect" which aims to detach adhesions and/or aponeurotic stenoses that cause a distress of cluneal nerves.
The aim of this study is to assess the effectiveness of the cluneal nerve block using theThomas Dahl Nielsen ultrasound based technique in patients with chronic low-back pain related to SCN-E. To this end, the investigator will compare physiological serum injection versus local anaesthetic injection, with the aim of reducing short-term pain and improving quality of life.
- Conditions
- Cluneal Syndrome, Nerve Entrapment Syndrome
- Being tested
- Ropivacaine injection, Physiological serum injection
- Keywords
- Superior cluneal nerve entrapment, Chronic Low-back Pain, Injection Site Infiltration, Local anesthetic, Pain, Cluneal nerve block
- Medical subject headings
- Charcot-Marie-Tooth Disease, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine injectionDrug
The patients will receive 15 ml of Ropivacaine 0.375 % on each side.
Physiological serum injectionDrug
The patients will receive 15 ml of physiological serum (NaCl 0.9 %) on each side.
| Study group | Role | What they receive |
|---|---|---|
| Physiological serum Group | Active comparator | The cluneal nerve block is performed under ultrasound using the Thomas Dahl Nielsen and Thomas Fichtner Bendtsen method.
The patients are placed in ventral decubitus. A sensor of high linear frequency is moved toward the middle and posterior to where the aponeurosis of the transverse muscle and the thoraco-lumbar fascia meet, following the appearance of the thoracolumbar fascia and then the appearance of the posterior ilio-costalis muscle under the fascia lumbar area. The infiltration is carried out "in-plane", with a lateral towards the median axis direction, in a way, that it penetrates perpendicularly the fascia
The physiological serum (NaCl 0.9%) will be injected, on each side, into the aponeurosis and the muscle in the area where the superior cluneal nerves pass. An easy separation of the thoraco- lumbar fascia and the ilio-costalis muscle is achieved during injection by slightly raising the needle towards the median axis as the space opens up gradually. Receives: Drug: Physiological serum injection |
| Ropivacaine Group | Experimental | The cluneal nerve block is performed under ultrasound using the Thomas Dahl Nielsen and Thomas Fichtner Bendtsen method.
The patients are placed in ventral decubitus. A sensor of high linear frequency is moved toward the middle and posterior to where the aponeurosis of the transverse muscle and the thoraco-lumbar fascia meet, following the appearance of the thoracolumbar fascia and then the appearance of the posterior ilio-costalis muscle under the fascia lumbar area. The infiltration is carried out "in-plane", with a lateral towards the median axis direction, in a way, that it penetrates perpendicularly the fascia
The local anaesthetic (Ropivacaine) will be injected into the aponeurosis and the muscle in the area where the superior cluneal nerves pass. An easy separation of the thoraco- lumbar fascia and the ilio-costalis muscle is achieved during injection by slightly raising the needle towards the median axis as the space opens up gradually. Receives: Drug: Ropivacaine injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of pain intensity in the acute phase of the treatment.
The pain intensity will be assessed using the numeric analogue scale (NAS) at 5 minutes, 30 minutes, 60 minutes and will be compared with (the pain intensity at) the baseline.
The patient rate the pain from 0 to 10 (0 = no pain; 10 = worst pain imaginable)
Measured: up to 1 hour post-infiltration
Secondary outcomes (3)
Reduction of pain in the late phase of the treatment.
The pain intensity will be assessed with the numeric analogue scale (NAS) at 15 days, 1 month, 3 month post-infiltration and will be compared with the pain intensity at the baseline.
The patient rate the pain from 0 to 10 (0 = no pain; 10 = worst pain imaginable)
Measured: up to 3 months post-infiltration
Impact of Pain on daily life
Impact of pain on daily life will be evaluated according to the Dallas Pain Questionnaire (DPQ).
The Dallas Pain Questionnaire (DPQ) is 16-item visual analog tool for evaluating how the chronic pain affects the daily activities (The higher the score, the greater the impact of low back pain on quality of life).
The impact on daily life will be evaluated before infiltration, 15 days, 1 month, 3 months after infiltration.
Measured: up to 3 months post-infiltration
Incidence of Side effects
Side effects will be collected such that the intolerance to the technique and/or injected product, traumatic complications
Measured: up to 3 months post-infiltration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study startJun 2022 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Why it stopped: Investigator left the team
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Collaborators
- Université Libre de Bruxelles
- Responsible party
- Sponsor
- Investigators
- Panayota Kapessidou, MD,PhD, Study director, Centre Hospitalier Universitaire Saint PierreWalid EL FOUNAS, MD, Principal investigator, Centre Hospitalier Universitaire Saint PierreAikaterini AMANATIDOU, MD, Principal investigator, Centre Hospitalier Universitaire Saint Pierre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423132
- Sponsor's protocol ID
- B0762022220503
- Status last verified
- Feb 2023
- First submitted
- 8 Jun 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Karri J, Singh M, Orhurhu V, Joshi M, Abd-Elsayed A. Pain Syndromes Secondary to Cluneal Nerve Entrapment. Curr Pain Headache Rep. 2020 Aug 21;24(10):61. doi: 10.1007/s11916-020-00891-7.
PubMed 32821979Randomised trial of ultrasounded guidelines above or cluneal nerve block "Superior Cluneal Nerve Entrapment - Pubmed." Accessed February 7, 2021.
Talu GK, Ozyalcin S, Talu U. Superior cluneal nerve entrapment. Reg Anesth Pain Med. 2000 Nov-Dec;25(6):648-50. doi: 10.1053/rapm.2000.18189.
PubMed 11097676Isu T, Kim K, Morimoto D, Iwamoto N. Superior and Middle Cluneal Nerve Entrapment as a Cause of Low Back Pain. Neurospine. 2018 Mar;15(1):25-32. doi: 10.14245/ns.1836024.012. Epub 2018 Mar 28.
PubMed 29656623Randomised trial of ultrasound-guided excess cluneal nerve block" Superior Cluneal Nerve Entrapment - Pubmed."
Morimoto D, Isu T, Kim K, Imai T, Yamazaki K, Matsumoto R, Isobe M. Surgical treatment of superior cluneal nerve entrapment neuropathy. J Neurosurg Spine. 2013 Jul;19(1):71-5. doi: 10.3171/2013.3.SPINE12420. Epub 2013 Apr 26.
PubMed 23621641Journal of Prolotherapy "The Management of Cluneal Nerve closed Pain with Prolotherapy," July 10, 2018
Hauser RA, Lackner JB, Steilen-Matias D, Harris DK. A Systematic Review of Dextrose Prolotherapy for Chronic Musculoskeletal Pain. Clin Med Insights Arthritis Musculoskelet Disord. 2016 Jul 7;9:139-59. doi: 10.4137/CMAMD.S39160. eCollection 2016.
PubMed 27429562
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Efficacy of Infiltration of Upper Cluneal Nerves in Chronic Pain Related to Cluneal Syndrome
- ClinicalTrials.gov ID
- NCT05423132
- Acronym / sponsor ID
- B0762022220503
- Conditions
- Cluneal Syndrome, Nerve Entrapment Syndrome
- Keywords
- Superior cluneal nerve entrapment, Chronic Low-back Pain, Injection Site Infiltration, Local anesthetic, Pain, Cluneal nerve block
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator left the team
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Collaborators
- Université Libre de Bruxelles
- Study start
- Jun 2022 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 21 Jun 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.
Lower back pain is a very common complaint in the Chronic Pain Clinic. Its etiology is nonspecific in 85% of the cases. In 1957, Strong and Davila reported that the superior cluneal nerves (SCNs) and middle cluneal nerves (MCNs) can be entrapped around the iliac crest, suggesting a causal relationship between this entrapment (SCN-Entrapment, SCN-E) and low back pain symptom. This is known today as "cluneal syndrome".
Cluneal syndrome remains poorly investigated and is currently a diagnostic challenge. Various types of lumbar movements exacerbate its occurence. The most common theory regarding the origin of this pain evokes that is primarily due to a mechanical cause linked to stenosis or adhesions of fibrous tissue around the cluneal nerves causing distress.
The hypothesis is that the investigator can reduce the pain related to the syndrome of superior cluneal origin thanks to a "volume effect" which aims to detach adhesions and/or aponeurotic stenoses that cause a distress of cluneal nerves.
The aim of this study is to assess the effectiveness of the cluneal nerve block using theThomas Dahl Nielsen ultrasound based technique in patients with chronic low-back pain related to SCN-E. To this end, the investigator will compare physiological serum injection versus local anaesthetic injection, with the aim of reducing short-term pain and improving quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiological serum Group | Active comparator | Drug: Physiological serum injectionThe cluneal nerve block is performed under ultrasound using the Thomas Dahl Nielsen and Thomas Fichtner Bendtsen method. The patients are placed in ventral decubitus. A sensor of high linear frequency is moved toward the middle and posterior to where the aponeurosis of the transverse muscle and the thoraco-lumbar fascia meet, following the appearance of the thoracolumbar fascia and then the appearance of the posterior ilio-costalis muscle under the fascia lumbar area. The infiltration is carried out "in-plane", with a lateral towards the median axis direction, in a way, that it penetrates perpendicularly the fascia The physiological serum (NaCl 0.9%) will be injected, on each side, into the aponeurosis and the muscle in the area where the superior cluneal nerves pass. An easy separation of the thoraco- lumbar fascia and the ilio-costalis muscle is achieved during injection by slightly raising the needle towards the median axis as the space opens up gradually. |
| Ropivacaine Group | Experimental | Drug: Ropivacaine injectionThe cluneal nerve block is performed under ultrasound using the Thomas Dahl Nielsen and Thomas Fichtner Bendtsen method. The patients are placed in ventral decubitus. A sensor of high linear frequency is moved toward the middle and posterior to where the aponeurosis of the transverse muscle and the thoraco-lumbar fascia meet, following the appearance of the thoracolumbar fascia and then the appearance of the posterior ilio-costalis muscle under the fascia lumbar area. The infiltration is carried out "in-plane", with a lateral towards the median axis direction, in a way, that it penetrates perpendicularly the fascia The local anaesthetic (Ropivacaine) will be injected into the aponeurosis and the muscle in the area where the superior cluneal nerves pass. An easy separation of the thoraco- lumbar fascia and the ilio-costalis muscle is achieved during injection by slightly raising the needle towards the median axis as the space opens up gradually. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient signed Inform Consent
- Patient diagnosed with unilateral or bilateral superior cluneal syndrome :
- a maximum pain at the trigger point on the back iliac crest, approximately 7 cm from the median line and 4.5 cm from the poster superior iliac crest. Palpation on this point causes pain reminding the patient's long-term pain),
- Palpation "rolled-palpated" at the buttocks provokes either pain, paraesthesia, or discomfort.
- The criteria of facial syndrome, sacro-iliac syndrome or radiculopathy are excluded.
Key exclusion criteria (5 listed)
- Pain not associated to superior cluneal syndrome.
- Infection at the puncture point.
- Pain of suspected neoplastic origin.
- Allergy to local anaesthetics.
- Refusal of the patient
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 |
|---|---|---|
| Ropivacaine injectionThe patients will receive 15 ml of Ropivacaine 0.375 % on each side. | Drug | Ropivacaine Group |
| Physiological serum injectionThe patients will receive 15 ml of physiological serum (NaCl 0.9 %) on each side. | Drug | Physiological serum Group |
Primary outcome
Reduction of pain intensity in the acute phase of the treatment.
Time frame: up to 1 hour post-infiltration
The pain intensity will be assessed using the numeric analogue scale (NAS) at 5 minutes, 30 minutes, 60 minutes and will be compared with (the pain intensity at) the baseline. The patient rate the pain from 0 to 10 (0 = no pain; 10 = worst pain imaginable)
3 secondary outcomes
Reduction of pain in the late phase of the treatment.
Time frame: up to 3 months post-infiltration
Impact of Pain on daily life
Time frame: up to 3 months post-infiltration
Incidence of Side effects
Time frame: up to 3 months post-infiltration
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Background: PubMed 32821979Karri J, Singh M, Orhurhu V, Joshi M, Abd-Elsayed A. Pain Syndromes Secondary to Cluneal Nerve Entrapment. Curr Pain Headache Rep. 2020 Aug 21;24(10):61. doi: 10.1007/s11916-020-00891-7.
- BackgroundRandomised trial of ultrasounded guidelines above or cluneal nerve block "Superior Cluneal Nerve Entrapment - Pubmed." Accessed February 7, 2021.
- Background: PubMed 11097676Talu GK, Ozyalcin S, Talu U. Superior cluneal nerve entrapment. Reg Anesth Pain Med. 2000 Nov-Dec;25(6):648-50. doi: 10.1053/rapm.2000.18189.
- Background: PubMed 29656623Isu T, Kim K, Morimoto D, Iwamoto N. Superior and Middle Cluneal Nerve Entrapment as a Cause of Low Back Pain. Neurospine. 2018 Mar;15(1):25-32. doi: 10.14245/ns.1836024.012. Epub 2018 Mar 28.
- BackgroundRandomised trial of ultrasound-guided excess cluneal nerve block" Superior Cluneal Nerve Entrapment - Pubmed."
- Background: PubMed 23621641Morimoto D, Isu T, Kim K, Imai T, Yamazaki K, Matsumoto R, Isobe M. Surgical treatment of superior cluneal nerve entrapment neuropathy. J Neurosurg Spine. 2013 Jul;19(1):71-5. doi: 10.3171/2013.3.SPINE12420. Epub 2013 Apr 26.
- BackgroundJournal of Prolotherapy "The Management of Cluneal Nerve closed Pain with Prolotherapy," July 10, 2018
- Background: PubMed 27429562Hauser RA, Lackner JB, Steilen-Matias D, Harris DK. A Systematic Review of Dextrose Prolotherapy for Chronic Musculoskeletal Pain. Clin Med Insights Arthritis Musculoskelet Disord. 2016 Jul 7;9:139-59. doi: 10.4137/CMAMD.S39160. eCollection 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Cluneal Syndrome
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RecruitingObservational study
Proximal Versus Distal Superior Cluneal Nerve Block in Entrapment Neuropathy
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Enrolling by invitation
Peng's "Fenjin Tuina" for Superior Cluneal Nerve Entrapment Syndrome: A Prospective, Randomized, Single-center Trial
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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.
Panayota Kapessidou, MD,PhD study director
Centre Hospitalier Universitaire Saint Pierre
Walid EL FOUNAS, MD principal investigator
Centre Hospitalier Universitaire Saint Pierre
Aikaterini AMANATIDOU, MD principal investigator
Centre Hospitalier Universitaire Saint Pierre
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine injection and Physiological serum injection in people with Cluneal Syndrome and Nerve Entrapment Syndrome, run by Centre Hospitalier Universitaire Saint Pierre.
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 7 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: withdrawn, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Reduction of pain intensity in the acute phase of the treatment. (time frame: up to 1 hour post-infiltration). 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 NCT05423132, which also lists 8 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 21 Feb 2023.