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

Primary Purpose

Cluneal Syndrome, Nerve Entrapment Syndrome

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ropivacaine injection
Physiological serum injection
Sponsored by
Centre Hospitalier Universitaire Saint Pierre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cluneal Syndrome focused on measuring Superior cluneal nerve entrapment, Chronic Low-back Pain, Injection Site Infiltration, Local anesthetic, Pain, Cluneal nerve block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Physiological serum Group

    Ropivacaine Group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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)

    Secondary Outcome Measures

    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)
    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.
    Incidence of Side effects
    Side effects will be collected such that the intolerance to the technique and/or injected product, traumatic complications

    Full Information

    First Posted
    June 8, 2022
    Last Updated
    February 16, 2023
    Sponsor
    Centre Hospitalier Universitaire Saint Pierre
    Collaborators
    Université Libre de Bruxelles
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05423132
    Brief Title
    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

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Investigator left the team
    Study Start Date
    June 2022 (Anticipated)
    Primary Completion Date
    October 2022 (Anticipated)
    Study Completion Date
    October 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire Saint Pierre
    Collaborators
    Université Libre de Bruxelles

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cluneal Syndrome, Nerve Entrapment Syndrome
    Keywords
    Superior cluneal nerve entrapment, Chronic Low-back Pain, Injection Site Infiltration, Local anesthetic, Pain, Cluneal nerve block

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Physiological serum Group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Ropivacaine Group
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Ropivacaine injection
    Intervention Description
    The patients will receive 15 ml of Ropivacaine 0.375 % on each side.
    Intervention Type
    Drug
    Intervention Name(s)
    Physiological serum injection
    Intervention Description
    The patients will receive 15 ml of physiological serum (NaCl 0.9 %) on each side.
    Primary Outcome Measure Information:
    Title
    Reduction of pain intensity in the acute phase of the treatment.
    Description
    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)
    Time Frame
    up to 1 hour post-infiltration
    Secondary Outcome Measure Information:
    Title
    Reduction of pain in the late phase of the treatment.
    Description
    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)
    Time Frame
    up to 3 months post-infiltration
    Title
    Impact of Pain on daily life
    Description
    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.
    Time Frame
    up to 3 months post-infiltration
    Title
    Incidence of Side effects
    Description
    Side effects will be collected such that the intolerance to the technique and/or injected product, traumatic complications
    Time Frame
    up to 3 months post-infiltration

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Panayota Kapessidou, MD,PhD
    Organizational Affiliation
    Centre Hospitalier Universitaire Saint Pierre
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Walid EL FOUNAS, MD
    Organizational Affiliation
    Centre Hospitalier Universitaire Saint Pierre
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Aikaterini AMANATIDOU, MD
    Organizational Affiliation
    Centre Hospitalier Universitaire Saint Pierre
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    32821979
    Citation
    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.
    Results Reference
    background
    Citation
    Randomised trial of ultrasounded guidelines above or cluneal nerve block "Superior Cluneal Nerve Entrapment - Pubmed." Accessed February 7, 2021.
    Results Reference
    background
    PubMed Identifier
    11097676
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    29656623
    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.
    Results Reference
    background
    PubMed Identifier
    31061111
    Citation
    Nielsen TD, Moriggl B, Barckman J, Jensen JM, Kolsen-Petersen JA, Soballe K, Borglum J, Bendtsen TF. Randomized trial of ultrasound-guided superior cluneal nerve block. Reg Anesth Pain Med. 2019 May 6:rapm-2018-100174. doi: 10.1136/rapm-2018-100174. Online ahead of print.
    Results Reference
    background
    PubMed Identifier
    23621641
    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.
    Results Reference
    background
    Citation
    Journal of Prolotherapy "The Management of Cluneal Nerve closed Pain with Prolotherapy," July 10, 2018
    Results Reference
    background
    PubMed Identifier
    27429562
    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.
    Results Reference
    background

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

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