Cervicobrachial NeuralgiaNCT04475445
Fluoroscopic Guided Interlaminar Epidural Versus Ultrasound Guided Transforaminal Epidural in the Treatment of Unilateral Cervicobrachialgia.
A study testing Ultrasound-guided transforaminal epidural steroid injection and Interlaminar epidural steroid injection in people with Cervicobrachial Neuralgia, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervicobrachial Neuralgia
- What is being tested?
- Ultrasound-guided transforaminal epidural steroid injection and Interlaminar epidural steroid injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Jul 2020to Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists physical status (ASA) I-III
- Chronic unilateral cervicobrachial pain
- Allowed Steroid infiltration
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
CHU Saint-Pierre
Brussels, 1000
Mohamed Ali Bali, MD, +32.2.535 ext. 3758, mohamed_bali@stpierre-bru.be
Panayota Kapessidou, MD, +32.2.535 ext. 3750, pkapessi@ulb.ac.be
About this study
Official title: 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.
- Conditions
- Cervicobrachial Neuralgia
- Being tested
- Ultrasound-guided transforaminal epidural steroid injection, Interlaminar epidural steroid injection
- Keywords
- Neuropathic Cervicobrachial, Ultrasound-guided transforaminal infiltration, Cervical Interlaminar epidural infiltration, Cervical Chronic Pain
- Medical subject headings
- Brachial Plexus Neuritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided transforaminal epidural steroid injectionOther
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.
Interlaminar epidural steroid injectionOther
Fluoroscopic location of the epidural space C5C6 or C6C7, injection of a mixture of 10 mg of dexamethasone and 20 mg of lidocaine.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided transforaminal epidural steroid injection | Experimental | Not described Receives: Other: Ultrasound-guided transforaminal epidural steroid injection |
| Interlaminar epidural steroid injection | Experimental | Not described Receives: Other: Interlaminar epidural steroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to 30 minutes
Secondary outcomes (6)
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)
Measured: up to 1 month
Patient satisfaction during procedure
Pain will be evaluated by Satisfaction scale after procedure (0= unsatisfied, 5= very satisfied)
Measured: 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.
Measured: up to 1 month
Rate of Procedure failure
The procedure will be considered as a failure if the infiltration is not performed.
Measured: up to 30 minutes
Incidence of Adverse effects (lipothymia, nausea, vomiting)
Measured: up to 1 month
Incidence of complications (stroke, hematoma, paralysis)
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start30 Jul 2020
- Primary completionJul 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cervicobrachial NeuralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Panayota Kapessidou, MD,PhD, Study director, University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)Mohamed Ali Bali, MD, Principal investigator, mohamed_bali@stpierre-bru.be
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475445
- Sponsor's protocol ID
- CE/20-04-08
- Status last verified
- Aug 2020
- First submitted
- 2 Jul 2020
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26606031Banik 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.
PubMed 31365368Bush 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.
PubMed 31535205Narouze 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.
PubMed 19574867
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluoroscopic Guided Interlaminar Epidural Versus Ultrasound Guided Transforaminal Epidural in the Treatment of Unilateral Cervicobrachialgia : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04475445
- Acronym / sponsor ID
- CE/20-04-08
- Conditions
- Cervicobrachial Neuralgia
- Keywords
- Neuropathic Cervicobrachial, Ultrasound-guided transforaminal infiltration, Cervical Interlaminar epidural infiltration, Cervical Chronic Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Study start
- 30 Jul 2020 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 17 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided transforaminal epidural steroid injection | Experimental | Other: Ultrasound-guided transforaminal epidural steroid injection |
| Interlaminar epidural steroid injection | Experimental | Other: Interlaminar epidural steroid injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists physical status (ASA) I-III
- Chronic unilateral cervicobrachial pain
- Allowed Steroid infiltration
Key exclusion criteria (7 listed)
- Pregnancy
- Lactation
- Allergy or intolerance to any of the drugs/materials used in this study,
- Participation in another interventional study
- Systemic anticoagulation,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-guided transforaminal epidural steroid injectionUltrasound 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. | Other | Ultrasound guided transforaminal epidural steroid injection |
| Interlaminar epidural steroid injectionFluoroscopic location of the epidural space C5C6 or C6C7, injection of a mixture of 10 mg of dexamethasone and 20 mg of lidocaine. | Other | Interlaminar epidural steroid injection |
Primary outcome
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)
6 secondary outcomes
Visual Analogue Score change at 1 month post infiltration when compared to baseline
Time frame: up to 1 month
Patient satisfaction during procedure
Time frame: at the end of infiltration
Neck disability index (NDI) score (questionnaire)
Time frame: up to 1 month
Rate of Procedure failure
Time frame: up to 30 minutes
Incidence of Adverse effects (lipothymia, nausea, vomiting)
Time frame: up to 1 month
Incidence of complications (stroke, hematoma, paralysis)
Time frame: up to 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
- Background: PubMed 26606031Kaye 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.
- Background: PubMed 31365368Banik 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.
- Background: PubMed 31535205Bush 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.
- Background: PubMed 19574867Narouze 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Panayota Kapessidou, MD,PhD study director
University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
Mohamed Ali Bali, MD principal investigator
mohamed_bali@stpierre-bru.be
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided transforaminal epidural steroid injection and Interlaminar epidural steroid injection in people with Cervicobrachial Neuralgia, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Panayota Kapessidou, MD,PhD (+32.2.535 ext. 3750, pkapessi@ulb.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Score change at 30 minutes post infiltration when compared to baseline (time frame: up to 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04475445, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2020.