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Fluoroscopic Guided Interlaminar Epidural Versus Ultrasound Guided Transforaminal Epidural in the Treatment of Unilateral Cervicobrachialgia.

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ClinicalTrials.gov Identifier: NCT04475445
Recruitment Status : Recruiting
First Posted : July 17, 2020
Last Update Posted : August 19, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Saint Pierre

Brief Summary:
Chronic cervicobrachialgia is a public health problem. Epidural injections of corticosteroids and local anesthesics via transforaminal and interlaminar routes both have shown their potential in its treatment. The interlaminar approach offers the advantage of an epidural injection (i.e., direct contact with the nerve root in the epidural space). However, it requires fluoroscopy and can lead to potentially serious complications (compression of the nerve root, spinal cord injury...). The ultrasound-guided injection of corticosteroids via the transforaminal route, which offers the advantage of selectively targeting the symptomatic nerve root, may have the same therapeutic advantages as the interlaminar approach in decreasing unilateral cervicobrachial pain (i.e. a decrease in pain after infiltration) and reduce its risks.The aim of this study is to compare the efficacy of transforaminal vs interlaminar cervical corticosteroid injection.

Condition or disease Intervention/treatment Phase
Cervicobrachial Neuralgia Other: Ultrasound-guided transforaminal epidural steroid injection Other: Interlaminar epidural steroid injection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fluoroscopic Guided Interlaminar Epidural Versus Ultrasound Guided Transforaminal Epidural in the Treatment of Unilateral Cervicobrachialgia : a Randomized Controlled Trial
Actual Study Start Date : July 30, 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ultrasound guided transforaminal epidural steroid injection Other: Ultrasound-guided transforaminal epidural steroid injection
Ultrasound identification of the nerve root, fluoroscopic control of the position and injection of a mixture of 10 mg of dexamethasone and 20 mg of lidocaine.

Experimental: Interlaminar epidural steroid injection Other: Interlaminar epidural steroid injection
Fluoroscopic location of the epidural space C5C6 or C6C7, injection of a mixture of 10 mg of dexamethasone and 20 mg of lidocaine.




Primary Outcome Measures :
  1. Visual Analogue Score change at 30 minutes post infiltration when compared to baseline [ Time Frame: up to 30 minutes ]

    Pain will be evaluated by Visual Analog Scale (VAS) before and 30 minutes after corticosteroid infiltration.

    Visual Analog pain score (scale = 0 no pain; 10= worst pain imaginable)



Secondary Outcome Measures :
  1. Visual Analogue Score change at 1 month post infiltration when compared to baseline [ Time Frame: up to 1 month ]

    Pain will be evaluated by Visual Analog Scale (VAS) before and 1 month after corticosteroid infiltration.

    Visual Analog pain score (scale = 0 no pain; 10= worst pain imaginable)


  2. Patient satisfaction during procedure [ Time Frame: at the end of infiltration ]
    Pain will be evaluated by Satisfaction scale after procedure (0= unsatisfied, 5= very satisfied)

  3. Neck disability index (NDI) score (questionnaire) [ Time Frame: up to 1 month ]

    Neck disability index (NDI) score will be calculated before, 30 minutes and 1 month after corticosteroid infiltration

    The NDI is a standard instrument for measuring self-rated disability due to neck pain.

    Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. Points summed to a total score. The test can be interpreted as a raw score, with a maximum score of 50, Interpretation for scoring intervals : 0 - 4 = no disability; 5 - 14 = mild disability; 15 - 24 = moderate disability; 25 - 34 = severe disability, above 34 = complete disability.


  4. Rate of Procedure failure [ Time Frame: up to 30 minutes ]
    The procedure will be considered as a failure if the infiltration is not performed.

  5. Incidence of Adverse effects (lipothymia, nausea, vomiting) [ Time Frame: up to 1 month ]
  6. Incidence of complications (stroke, hematoma, paralysis) [ Time Frame: up to 1 month ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists physical status (ASA) I-III
  • Chronic unilateral cervicobrachial pain
  • Allowed Steroid infiltration

Exclusion Criteria:

  • Pregnancy
  • Lactation
  • Allergy or intolerance to any of the drugs/materials used in this study,
  • Participation in another interventional study
  • Systemic anticoagulation,
  • Infection at the puncture site
  • Patient refusal.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04475445


Contacts
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Contact: Panayota Kapessidou, MD,PhD +32.2.535 ext 3750 pkapessi@ulb.ac.be
Contact: Mohamed Ali Bali, MD + 32.2.535 ext 3758 mohamed_bali@stpierre-bru.be

Locations
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Belgium
CHU Saint-Pierre Recruiting
Bruxelles, Belgium, 1000
Contact: Mohamed Ali Bali, MD    +32.2.535 ext 3758    mohamed_bali@stpierre-bru.be   
Contact: Panayota Kapessidou, MD    +32.2.535 ext 3750    pkapessi@ulb.ac.be   
Principal Investigator: Mohamed Bali, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire Saint Pierre
Investigators
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Study Director: Panayota Kapessidou, MD,PhD University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
Principal Investigator: Mohamed Ali Bali, MD mohamed_bali@stpierre-bru.be
Publications:
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Responsible Party: Centre Hospitalier Universitaire Saint Pierre
ClinicalTrials.gov Identifier: NCT04475445    
Other Study ID Numbers: CE/20-04-08
First Posted: July 17, 2020    Key Record Dates
Last Update Posted: August 19, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire Saint Pierre:
Neuropathic Cervicobrachial
Ultrasound-guided transforaminal infiltration
Cervical Interlaminar epidural infiltration
Cervical Chronic Pain
Additional relevant MeSH terms:
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Neuralgia
Brachial Plexus Neuritis
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Brachial Plexus Neuropathies
Neuritis