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

Fluoroscopic Guided Interlaminar Epidural Versus Ultrasound Guided Transforaminal Epidural in the Treatment of Unilateral Cervicobrachialgia : a Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Cervicobrachial Neuralgia
• Intervention / Treatment: Other: Ultrasound-guided transforaminal epidural steroid injection; Other: Interlaminar epidural steroid injection

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Ali Bali, MD; Phone Number: 3758 + 32.2.535; Email: mohamed_bali@stpierre-bru.be

Study Locations

• Belgium
  • Bruxelles, Belgium, 1000
    • Recruiting
    • CHU Saint-Pierre
    • Contact: Mohamed Ali Bali, MD; Phone Number: 3758 +32.2.535; Email: mohamed_bali@stpierre-bru.be
    • Contact: Panayota Kapessidou, MD; Phone Number: 3750 +32.2.535; Email: pkapessi@ulb.ac.be
    • Principal Investigator: Mohamed Bali, MD

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Score change at 30 minutes post infiltration when compared to baseline	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)	up to 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Score change at 1 month post infiltration when compared to baseline	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)	up to 1 month
Patient satisfaction during procedure	Pain will be evaluated by Satisfaction scale after procedure (0= unsatisfied, 5= very satisfied)	at the end of infiltration
Neck disability index (NDI) score (questionnaire)	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.	up to 1 month
Rate of Procedure failure	The procedure will be considered as a failure if the infiltration is not performed.	up to 30 minutes
Incidence of Adverse effects (lipothymia, nausea, vomiting)		up to 1 month
Incidence of complications (stroke, hematoma, paralysis)		up to 1 month

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Saint Pierre
• Investigators: Principal Investigator: Mohamed Ali Bali, MD, mohamed_bali@stpierre-bru.be

Publications and helpful links

General Publications

• Kaye AD, Manchikanti L, Abdi S, Atluri S, Bakshi S, Benyamin R, Boswell MV, Buenaventura R, Candido KD, Cordner HJ, Datta S, Doulatram G, Gharibo CG, Grami V, Gupta S, Jha S, Kaplan ED, Malla Y, Mann DP, Nampiaparampil DE, Racz G, Raj P, Rana MV, Sharma ML, Singh V, Soin A, Staats PS, Vallejo R, Wargo BW, Hirsch JA. Efficacy of Epidural Injections in Managing Chronic Spinal Pain: A Best Evidence Synthesis. Pain Physician. 2015 Nov;18(6):E939-1004.
• Banik RK, Chen Chen CC. Spinal Epidural Hematoma after Interlaminar Cervical Epidural Steroid Injection. Anesthesiology. 2019 Dec;131(6):1342-1343. doi: 10.1097/ALN.0000000000002896. No abstract available.
• Bush K, Mandegaran R, Robinson E, Zavareh A. The safety and efficiency of performing cervical transforaminal epidural steroid injections under fluoroscopic control on an ambulatory/outpatient basis. Eur Spine J. 2020 May;29(5):994-1000. doi: 10.1007/s00586-019-06147-2. Epub 2019 Sep 18.
• Narouze SN, Vydyanathan A, Kapural L, Sessler DI, Mekhail N. Ultrasound-guided cervical selective nerve root block: a fluoroscopy-controlled feasibility study. Reg Anesth Pain Med. 2009 Jul-Aug;34(4):343-8. doi: 10.1097/AAP.0b013e3181ac7e5c.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 30, 2020
• Primary Completion (ANTICIPATED): July 1, 2021
• Study Completion (ANTICIPATED): July 1, 2021

Study Registration Dates

• First Submitted: July 2, 2020
• First Submitted That Met QC Criteria: July 14, 2020
• First Posted (ACTUAL): July 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 19, 2020
• Last Update Submitted That Met QC Criteria: August 17, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Neuropathic Cervicobrachial; Ultrasound-guided transforaminal infiltration; Cervical Interlaminar epidural infiltration; Cervical Chronic Pain
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Brachial Plexus Neuropathies; Neuritis; Neuralgia; Brachial Plexus Neuritis
• Other Study ID Numbers: CE/20-04-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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