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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04454541
Other study ID # UBLOCK
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2019
Est. completion date December 1, 2019

Study information

Verified date June 2020
Source Abha International Private Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Background: Cervicogenic headache (CH) described as a chronic hemi-cranial pain resulted from a disorder of the cervical spine and its anatomic structures innervated by the C1, C2, and C3 cervical spinal nerves. Traditionally noninvasive and invasive techniques were used for treatment. Greater occipital nerve block is the most frequent peripheral nerve block invasive technique used for the management of cervicogenic headache Objectives: The study was done to compare the efficacy of two different techniques: multifidus cervicus plan block and greater occipital nerve block in treatment of refractory cervicogenic headache using ultrasound guided.

Patients and Methods: sixty patients with cervicogenic headache were recruited and diagnosed according to ICHD-ш Beta version. Divided into two group, one for greater occipital nerve block and the other for multifidus cervicis plane block with ultrasound guided.


Description:

This study was done to compare the efficacy of two different techniques: multifidus cervicus plane block and greater occipital nerve block in treatment of cervicogenic headache using ultrasound guided.

This prospective study that was approved by Institutional Review Board (IRB), Mansoura Faculty of Medicine, Mansoura University, Cairo Egypt (Code Number: R/19.04.483) and all participants gave written informed consent. The procedures followed were in accordance with our protocol.

This study included patients with cervicogenic headache disorders that diagnosed according to International Classification of Headache Disorder version III (ICHD-III beta version) criteria (18)

Full clinical neurological examination was done for all patients. Blood samples for routine laboratory investigations (Complete blood count, creatinine, liver function tests, PT, APTT) were taken from all patients, electrocardiography (ECG) were done for all patients. Pain intensity was evaluated via visual analog scale (VAS) scores (0 -10). Pain intensity evaluation will be done at initial presentation then after 2 and 4 weeks, using the VAS scale for affected side of cervicogenic headache. Saturation of pulse oxygen (SpO2), all Procedures performed using ultrasound system with a 7 - 13 MHz multi-frequency transducer (LOGIQ P5; GE Healthcare).


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 1, 2019
Est. primary completion date November 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

History of occipital nerve injection, occipital nerve stimulation or history of surgical procedures in the occipital region,

Exclusion Criteria:

- History of allergic reaction to the substance to be applied as local anesthetic.,

- Pregnancy or lactation,

- Uncontrolled hypertension,

- Uncontrolled diabetes mellitus,

- Uncompensated congestive heart failure,

- Chronic renal failure,

- Chronic liver disease,

- Tumor and/or vascular disease,

- Inflammatory and/or infectious diseases,

- Anticoagulant or antiplatelet medication use that may interfere with the injection process were also excluded.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Ultrasound-guided nerve block for headache management
The study was done to compare the efficacy of two different techniques: multifidus cervicus plan block and greater occipital nerve block in treatment of refractory cervicogenic headache using ultrasound guided.

Locations

Country Name City State
Egypt Mansoura University Mansoura

Sponsors (1)

Lead Sponsor Collaborator
Abha International Private Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Docekal, P., Keller, O., Marková, J., Opavský, J. (2006) Bolesti hlavy. In: Bolest. Rokyta, R., Kršiak, M., Kozák, J., pp. 2006; 461-477, Tigis, Praha. (in Czech). International Headache Society .The International Classification of Headache Disorders, 2nd edition. Cephalalgia. 2004; 24, 1-160 (Suppl. 1). Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. Fredriksen TA, Antonaci F, Sjaastad O. Cervicogenic headache: too important to be left un-diagnosed. J Headache Pain 2015; 16:6. Chaibi A, Russell MB. Manual therapies for cervicogenic headache: a systematic review. J Headache Pain. 2012; 13:351-359.

Outcome

Type Measure Description Time frame Safety issue
Primary Headache free 30 minute post intervention
Secondary Visual analog scale (VAS) 2 Weeks
Secondary Visual analog scale (VAS) 4 Weeks
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