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Efficacy of Ultrasound-Guided Multifidus Cervicis Plan Block Vs Greater Occipital Nerve Block for Cervicogenic Headache (UBLOC)

Primary Purpose

Cervicogenic Headache

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ultrasound-guided nerve block for headache management
Sponsored by
Abha International Private Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervicogenic Headache focused on measuring Cervicogenic Headache, Headache, Cervicis Plan Block, Occipital Nerve Block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mansoura University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Greater occipital nerve block with ultrasound

Multifidus cervicis plane block with ultrasound guided

Arm Description

A-Greater occipital nerve block The ultrasound-guided GONB was performed to more accurately locate the nerve. The patient was asked to lie prone on the table. To locate the nerve, we searched for the occipital artery in the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process. The scalp was cleaned with iodine. After that, the skin was sterilized, and the probe was sheathed in a sterile plastic package GONB was performed by applying the injection to the medial of the artery. A 22-gauge needle was advanced beneath the lateral border of the probe using real-time ultrasound guidance and an in-plane technique. In all patients the occipital nerve was seen medial to the artery. The injected side was determined by the patients' clinical symptoms and according to the painful side reported in their headache diaries. The patients were required to lie down for 30 minutes after the injection to avoid dizziness.

Patients placed in a lateral position with their affected side upwards. Several gel cushions were placed under their head, neck, and arm to put the neck in a stable and slightly anterior flexion position spinal level was determined by identifying the transverse process of the seventh and sixth cervical vertebrae (C7 and C6). The seventh cervical transverse process (C7) differs from the levels above by having a rudimentary anterior tubercle and a prominent posterior tubercle. After aseptic preparation of the injection area, lidocaine 1% was used to anesthetize the skin. Under continuous ultrasound guidance, the needle (22-G, 0.7 mm × 60 mm, Plexufx, B-BRAUN, Tokyo, Japan) was introduced in-plane through the skin and advanced into the fascial plane between the multifidus cervicis and semispinalis cervicis muscles for the MCP block.

Outcomes

Primary Outcome Measures

Headache free

Secondary Outcome Measures

Visual analog scale (VAS)
Visual analog scale (VAS)

Full Information

First Posted
May 13, 2020
Last Updated
June 30, 2020
Sponsor
Abha International Private Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04454541
Brief Title
Efficacy of Ultrasound-Guided Multifidus Cervicis Plan Block Vs Greater Occipital Nerve Block for Cervicogenic Headache
Acronym
UBLOC
Official Title
The Efficacy of Ultrasound -Guided Multifidus Cervicis Plan Block Versus Greater Occipital Nerve Block for Cervicogenic Headache
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abha International Private Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervicogenic Headache
Keywords
Cervicogenic Headache, Headache, Cervicis Plan Block, Occipital Nerve Block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Arm A-Greater occipital nerve block The ultrasound-guided GONB was performed to more accurately locate the nerve. The patient was asked to lie prone on the table. To locate the nerve, we searched for the occipital artery in the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process. Arm B- Multifidus cervicus plan block group (MCPB) Patients will receive continuing low-flow non humidified nasal cannula oxygen (2 L/min) and continued intravenous infusion of Ringer's solution while respiratory signs were closely monitored during the procedure.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Greater occipital nerve block with ultrasound
Arm Type
Active Comparator
Arm Description
A-Greater occipital nerve block The ultrasound-guided GONB was performed to more accurately locate the nerve. The patient was asked to lie prone on the table. To locate the nerve, we searched for the occipital artery in the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process. The scalp was cleaned with iodine. After that, the skin was sterilized, and the probe was sheathed in a sterile plastic package GONB was performed by applying the injection to the medial of the artery. A 22-gauge needle was advanced beneath the lateral border of the probe using real-time ultrasound guidance and an in-plane technique. In all patients the occipital nerve was seen medial to the artery. The injected side was determined by the patients' clinical symptoms and according to the painful side reported in their headache diaries. The patients were required to lie down for 30 minutes after the injection to avoid dizziness.
Arm Title
Multifidus cervicis plane block with ultrasound guided
Arm Type
Experimental
Arm Description
Patients placed in a lateral position with their affected side upwards. Several gel cushions were placed under their head, neck, and arm to put the neck in a stable and slightly anterior flexion position spinal level was determined by identifying the transverse process of the seventh and sixth cervical vertebrae (C7 and C6). The seventh cervical transverse process (C7) differs from the levels above by having a rudimentary anterior tubercle and a prominent posterior tubercle. After aseptic preparation of the injection area, lidocaine 1% was used to anesthetize the skin. Under continuous ultrasound guidance, the needle (22-G, 0.7 mm × 60 mm, Plexufx, B-BRAUN, Tokyo, Japan) was introduced in-plane through the skin and advanced into the fascial plane between the multifidus cervicis and semispinalis cervicis muscles for the MCP block.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided nerve block for headache management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Headache free
Time Frame
30 minute post intervention
Secondary Outcome Measure Information:
Title
Visual analog scale (VAS)
Time Frame
2 Weeks
Title
Visual analog scale (VAS)
Time Frame
4 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zenat Eldadamony Mohamed, PhD MD
Organizational Affiliation
Mansoura University
Official's Role
Study Chair
Facility Information:
Facility Name
Mansoura University
City
Mansoura
Country
Egypt

12. IPD Sharing Statement

Citations:
Citation
Dočekal, 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.
Results Reference
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Efficacy of Ultrasound-Guided Multifidus Cervicis Plan Block Vs Greater Occipital Nerve Block for Cervicogenic Headache

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