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

Nerve Entrapment Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05423132
• Other study ID #: B0762022220503
• Status: Withdrawn
• Phase: N/A
• Start date: June 2022
• Est. completion date: October 2022

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Universitaire Saint Pierre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Charcot-Marie-Tooth Disease
• Chronic Pain
• Hereditary Sensory and Motor Neuropathy
• Nerve Compression Syndromes
• Nerve Entrapment Syndrome
• Syndrome

Intervention

Drug:
• Ropivacaine injection
The patients will receive 15 ml of Ropivacaine 0.375 % on each side.
• Physiological serum injection
The patients will receive 15 ml of physiological serum (NaCl 0.9 %) on each side.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Saint Pierre	Université Libre de Bruxelles

References & Publications (8)

A systematic review of dextrose Prolotherapy for Chronic musculoskeletal Pain." Accessed February 7, 2021.

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. — View Citation

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

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. — View 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. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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