Cervicobrachial Neuralgia Clinical Trial
Official title:
Fluoroscopic Guided Interlaminar Epidural Versus Ultrasound Guided Transforaminal Epidural in the Treatment of Unilateral Cervicobrachialgia : a Randomized Controlled Trial
NCT number | NCT04475445 |
Other study ID # | CE/20-04-08 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 30, 2020 |
Est. completion date | July 2021 |
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | July 2021 |
Est. primary completion date | July 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Belgium | CHU Saint-Pierre | Bruxelles |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire Saint Pierre |
Belgium,
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. — View 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. — View 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. Review. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | Patient satisfaction during procedure | Pain will be evaluated by Satisfaction scale after procedure (0= unsatisfied, 5= very satisfied) | at the end of infiltration | |
Secondary | 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 | |
Secondary | Rate of Procedure failure | The procedure will be considered as a failure if the infiltration is not performed. | up to 30 minutes | |
Secondary | Incidence of Adverse effects (lipothymia, nausea, vomiting) | up to 1 month | ||
Secondary | Incidence of complications (stroke, hematoma, paralysis) | up to 1 month |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00241215 -
Study to Evaluate the Efficacy of Botulinum Toxin Serotype A Injections for Cervicobrachial Myofascial Syndrome
|
Phase 4 | |
Completed |
NCT02595294 -
Hypoalgesic Effect of Neural Mobilization
|
N/A | |
Completed |
NCT02596815 -
Hypoalgesic Effect of Median Nerve Neural Mobilization Compared to a Controlled Group
|
N/A | |
Completed |
NCT02593721 -
Hypoalgesic Effect of Neural Mobilization Versus Ibuprofen Pharmacologic Treatment
|
Phase 2/Phase 3 | |
Recruiting |
NCT03397459 -
Cervicobrachial Neuralgia and Sagital Balance of the Cervical Spine
|
N/A | |
Completed |
NCT02632357 -
Longitudinal Experimental Study on ULNTT and Cervico-Thoracic Spine Motion Patterns Relationship
|
N/A | |
Completed |
NCT01518582 -
GRANVIA®-C Cervical Disc Prosthesis Multicenter European Pilot Study
|
N/A |