Study on the Efficacy of Infiltration of Upper Cluneal Nerves in Chronic Pain Related to Cluneal Syndrome

NCT ID: NCT05423132

Last Updated: 2023-02-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-30
• Study Completion Date: 2022-10-31

Brief 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 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.

Conditions

Cluneal Syndrome; Nerve Entrapment Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Physiological serum Group

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.

Group Type: ACTIVE_COMPARATOR

Physiological serum injection

Intervention Type: DRUG

The patients will receive 15 ml of physiological serum (NaCl 0.9 %) on each side.

Ropivacaine Group

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.

Group Type: EXPERIMENTAL

Ropivacaine injection

Intervention Type: DRUG

The patients will receive 15 ml of Ropivacaine 0.375 % on each side.

Interventions

Ropivacaine injection

The patients will receive 15 ml of Ropivacaine 0.375 % on each side.

Intervention Type: DRUG

Physiological serum injection

The patients will receive 15 ml of physiological serum (NaCl 0.9 %) on each side.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patient signed Inform Consent

2. 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.

Exclusion Criteria

1. Pain not associated to superior cluneal syndrome.

2. Infection at the puncture point.

3. Pain of suspected neoplastic origin.

4. Allergy to local anaesthetics.

5. Refusal of the patient

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Université Libre de Bruxelles

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire Saint Pierre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Panayota Kapessidou, MD,PhD

Role: STUDY_DIRECTOR

Centre Hospitalier Universitaire Saint Pierre

Walid EL FOUNAS, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Saint Pierre

Aikaterini AMANATIDOU, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Saint Pierre

References

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.

Reference Type: BACKGROUND

PMID: 32821979 (View on PubMed)

Randomised trial of ultrasounded guidelines above or cluneal nerve block "Superior Cluneal Nerve Entrapment - Pubmed." Accessed February 7, 2021.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 11097676 (View on PubMed)

Isu 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.

Reference Type: BACKGROUND

PMID: 29656623 (View on PubMed)

Randomised trial of ultrasound-guided excess cluneal nerve block" Superior Cluneal Nerve Entrapment - Pubmed."

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 23621641 (View on PubMed)

Journal of Prolotherapy "The Management of Cluneal Nerve closed Pain with Prolotherapy," July 10, 2018

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 27429562 (View on PubMed)

Other Identifiers

B0762022220503

Identifier Type: -

Identifier Source: org_study_id