Fluoroscopic Guided Interlaminar Epidural Versus Ultrasound Guided Transforaminal Epidural in the Treatment of Unilateral Cervicobrachialgia.
Primary Purpose
Cervicobrachial Neuralgia
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Ultrasound-guided transforaminal epidural steroid injection
Interlaminar epidural steroid injection
Sponsored by
About this trial
This is an interventional treatment trial for Cervicobrachial Neuralgia focused on measuring Neuropathic Cervicobrachial, Ultrasound-guided transforaminal infiltration, Cervical Interlaminar epidural infiltration, Cervical Chronic Pain
Eligibility 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.
Sites / Locations
- CHU Saint-PierreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Ultrasound guided transforaminal epidural steroid injection
Interlaminar epidural steroid injection
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
Patient satisfaction during procedure
Pain will be evaluated by Satisfaction scale after procedure (0= unsatisfied, 5= very satisfied)
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.
Rate of Procedure failure
The procedure will be considered as a failure if the infiltration is not performed.
Incidence of Adverse effects (lipothymia, nausea, vomiting)
Incidence of complications (stroke, hematoma, paralysis)
Full Information
NCT ID
NCT04475445
First Posted
July 2, 2020
Last Updated
August 17, 2020
Sponsor
Centre Hospitalier Universitaire Saint Pierre
1. Study Identification
Unique Protocol Identification Number
NCT04475445
Brief Title
Fluoroscopic Guided Interlaminar Epidural Versus Ultrasound Guided Transforaminal Epidural in the Treatment of Unilateral Cervicobrachialgia.
Official Title
Fluoroscopic Guided Interlaminar Epidural Versus Ultrasound Guided Transforaminal Epidural in the Treatment of Unilateral Cervicobrachialgia : a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 30, 2020 (Actual)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
July 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Saint Pierre
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervicobrachial Neuralgia
Keywords
Neuropathic Cervicobrachial, Ultrasound-guided transforaminal infiltration, Cervical Interlaminar epidural infiltration, Cervical Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound guided transforaminal epidural steroid injection
Arm Type
Experimental
Arm Title
Interlaminar epidural steroid injection
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Ultrasound-guided transforaminal epidural steroid injection
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Interlaminar epidural steroid injection
Intervention Description
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 Measure Information:
Title
Visual Analogue Score change at 30 minutes post infiltration when compared to baseline
Description
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)
Time Frame
up to 30 minutes
Secondary Outcome Measure Information:
Title
Visual Analogue Score change at 1 month post infiltration when compared to baseline
Description
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)
Time Frame
up to 1 month
Title
Patient satisfaction during procedure
Description
Pain will be evaluated by Satisfaction scale after procedure (0= unsatisfied, 5= very satisfied)
Time Frame
at the end of infiltration
Title
Neck disability index (NDI) score (questionnaire)
Description
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.
Time Frame
up to 1 month
Title
Rate of Procedure failure
Description
The procedure will be considered as a failure if the infiltration is not performed.
Time Frame
up to 30 minutes
Title
Incidence of Adverse effects (lipothymia, nausea, vomiting)
Time Frame
up to 1 month
Title
Incidence of complications (stroke, hematoma, paralysis)
Time Frame
up to 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Panayota Kapessidou, MD,PhD
Phone
+32.2.535
Ext
3750
Email
pkapessi@ulb.ac.be
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Ali Bali, MD
Phone
+ 32.2.535
Ext
3758
Email
mohamed_bali@stpierre-bru.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Panayota Kapessidou, MD,PhD
Organizational Affiliation
University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohamed Ali Bali, MD
Organizational Affiliation
mohamed_bali@stpierre-bru.be
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Saint-Pierre
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Ali Bali, MD
Phone
+32.2.535
Ext
3758
Email
mohamed_bali@stpierre-bru.be
First Name & Middle Initial & Last Name & Degree
Panayota Kapessidou, MD
Phone
+32.2.535
Ext
3750
Email
pkapessi@ulb.ac.be
First Name & Middle Initial & Last Name & Degree
Mohamed Bali, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26606031
Citation
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.
Results Reference
background
PubMed Identifier
31365368
Citation
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.
Results Reference
background
PubMed Identifier
31535205
Citation
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.
Results Reference
background
PubMed Identifier
19574867
Citation
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.
Results Reference
background
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Fluoroscopic Guided Interlaminar Epidural Versus Ultrasound Guided Transforaminal Epidural in the Treatment of Unilateral Cervicobrachialgia.
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