Clinical trial NCT05423132: Study on the Efficacy of Infiltration of Upper Cluneal Nerves in Chronic Pain Related to Cluneal Syndrome
Official title: Study on the Efficacy of Infiltration of Upper Cluneal Nerves in Chronic Pain Related to Cluneal Syndrome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cluneal Syndrome
Nerve Entrapment Syndrome
Keywords: Superior cluneal nerve entrapment
Chronic Low-back Pain
Injection Site Infiltration
Local anesthetic
Pain
Cluneal nerve block
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
Collaborators: name: Université Libre de Bruxelles
First posted: 2022-06-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Reduction of pain intensity in the acute phase of the treatment.
timeFrame: up to 1 hour post-infiltration
Secondary outcomes:
measure: Reduction of pain in the late phase of the treatment.
timeFrame: up to 3 months post-infiltration
measure: Impact of Pain on daily life
timeFrame: up to 3 months post-infiltration
measure: Incidence of Side effects
timeFrame: up to 3 months post-infiltration
Other outcomes:
Locations:
Study officials:
affiliation: Centre Hospitalier Universitaire Saint Pierre
name: Panayota Kapessidou, MD,PhD
role: STUDY_DIRECTOR
affiliation: Centre Hospitalier Universitaire Saint Pierre
name: Walid EL FOUNAS, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universitaire Saint Pierre
name: Aikaterini AMANATIDOU, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: Randomised trial of ultrasound-guided excess cluneal nerve block" Superior Cluneal Nerve Entrapment - Pubmed."
citation: 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.
citation: Journal of Prolotherapy "The Management of Cluneal Nerve closed Pain with Prolotherapy," July 10, 2018
citation: 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.