Cervicogenic HeadacheUBLOCNCT04454541
Efficacy of Ultrasound-Guided Multifidus Cervicis Plan Block Vs Greater Occipital Nerve Block for Cervicogenic Headache
A study testing Ultrasound-guided nerve block for headache management in people with Cervicogenic Headache, run by Abha International Private Hospital at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervicogenic Headache
- What is being tested?
- Ultrasound-guided nerve block for headache management
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2019to 1 Dec 2019
- 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
- History of occipital nerve injection, occipital nerve stimulation or history of surgical procedures in the occipital region,
Who cannot join
- 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,
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Ultrasound -Guided Multifidus Cervicis Plan Block Versus Greater Occipital Nerve Block for Cervicogenic Headache
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.
Read the 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).
- Conditions
- Cervicogenic Headache
- Being tested
- Ultrasound-guided nerve block for headache management
- Keywords
- Cervicogenic Headache, Headache, Cervicis Plan Block, Occipital Nerve Block
- Medical subject headings
- Post-Traumatic Headache, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided nerve block for headache managementProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Greater occipital nerve block with ultrasound | Active comparator | 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. Receives: Procedure: Ultrasound-guided nerve block for headache management |
| Multifidus cervicis plane block with ultrasound guided | Experimental | 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. Receives: Procedure: Ultrasound-guided nerve block for headache management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache free
Measured: 30 minute post intervention
Secondary outcomes (2)
Visual analog scale (VAS)
Measured: 2 Weeks
Visual analog scale (VAS)
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start1 May 2019
- Primary completion1 Nov 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervicogenic HeadacheStudies 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
- 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)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abha International Private Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zenat Eldadamony Mohamed, PhD MD, Study chair, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04454541
- Sponsor's protocol ID
- UBLOCK
- Acronym
- UBLOC
- Status last verified
- Jun 2020
- First submitted
- 13 May 2020
- Last updated
- 1 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Ultrasound -Guided Multifidus Cervicis Plan Block Versus Greater Occipital Nerve Block for Cervicogenic Headache
- ClinicalTrials.gov ID
- NCT04454541
- Acronym / sponsor ID
- UBLOC / UBLOCK
- Conditions
- Cervicogenic Headache
- Keywords
- Cervicogenic Headache, Headache, Cervicis Plan Block, Occipital Nerve Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Abha International Private HospitalUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 1 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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Greater occipital nerve block with ultrasound | Active comparator | Procedure: Ultrasound-guided nerve block for headache managementA-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. |
| Multifidus cervicis plane block with ultrasound guided | Experimental | Procedure: Ultrasound-guided nerve block for headache managementPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- History of occipital nerve injection, occipital nerve stimulation or history of surgical procedures in the occipital region,
Key exclusion criteria (10 listed)
- 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,
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 nerve block for headache managementThe 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. | Procedure or surgery | Greater occipital nerve block with ultrasound, Multifidus cervicis plane block with ultrasound guided |
Primary outcome
Headache free
Time frame: 30 minute post intervention
2 secondary outcomes
Visual analog scale (VAS)
Time frame: 2 Weeks
Visual analog scale (VAS)
Time frame: 4 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
- BackgroundDočekal, 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.
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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.
Zenat Eldadamony Mohamed, PhD MD study chair
Mansoura University
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 nerve block for headache management in people with Cervicogenic Headache, run by Abha International Private Hospital at 1 site in Egypt.
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 1 inclusion and 10 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: finished, as of the sponsor's last update on 1 Jul 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache free (time frame: 30 minute post intervention). 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 NCT04454541, which also lists 1 linked publication.
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 1 Jul 2020.