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

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 Overview

• Status: Withdrawn
• Conditions: Nerve Entrapment Syndrome; Cluneal Syndrome
• Intervention / Treatment: Drug: Physiological serum injection; Drug: Ropivacaine injection

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1000
    • CHU Saint-Pierre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Physiological serum injection; The patients will receive 15 ml of physiological serum (NaCl 0.9 %) on each side.
Experimental: 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.	Drug: Ropivacaine injection; The patients will receive 15 ml of Ropivacaine 0.375 % on each side.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	up to 1 hour post-infiltration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	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	up to 3 months post-infiltration

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Saint Pierre
• Collaborators: Université Libre de Bruxelles
• Investigators: Study Director: Panayota Kapessidou, MD,PhD, Centre Hospitalier Universitaire Saint Pierre; Principal Investigator: Walid EL FOUNAS, MD, Centre Hospitalier Universitaire Saint Pierre; Principal Investigator: Aikaterini AMANATIDOU, MD, Centre Hospitalier Universitaire Saint Pierre

Publications and helpful links

General 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.
• Randomised 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.
• 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.
• Randomised 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.
• Journal of Prolotherapy "The Management of Cluneal Nerve closed Pain with Prolotherapy," July 10, 2018
• A systematic review of dextrose Prolotherapy for Chronic musculoskeletal Pain." Accessed February 7, 2021.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: June 14, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Estimate): February 20, 2023
• Last Update Submitted That Met QC Criteria: February 16, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Local anesthetic; Chronic Low-back Pain; Superior cluneal nerve entrapment; Injection Site Infiltration; Cluneal nerve block
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Pain; Neurologic Manifestations; Disease; Congenital Abnormalities; Genetic Diseases, Inborn; Neuromuscular Diseases; Neurodegenerative Diseases; Peripheral Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Nervous System Malformations; Polyneuropathies; Syndrome; Chronic Pain; Nerve Compression Syndromes; Charcot-Marie-Tooth Disease; Hereditary Sensory and Motor Neuropathy; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: B0762022220503

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No