Primary HeadacheGONNCT02031822
Two US-guided Techniques for Greater Occipital Nerve Blocks
A study testing US-guided Greater Occipital Nerve Injection in people with Primary Headache, run by University Health Network, Toronto at 2 sites in Canada.
Trial summary
Headache is one of the most common reasons for patients to access healthcare. Greater occipital nerve (GON) block with local anesthetic and steroid has been described for the management of primary headache refractory to conventional treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Headache
- What is being tested?
- US-guided Greater Occipital Nerve Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesCanada
- Study dates
- Jun 2014to May 2018
- 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
- Features suggestive of occipital neuralgia: pain that begins in the upper neck and back of the head with radiation forward toward the eye and has an aching or burning character.
- Diagnosis of refractory primary headache, any type
- Baseline NRS headache score of > 4 refractory to conventional oral analgesic therapy (anti-inflammatory drugs, migraine prophylaxis and treatment drugs, opioids).
Who cannot join
- Ongoing litigation issues related to the patient's pain
- Pregnancy
- Allergy to steroids or local anesthetics
- Multiple serious comorbidities
- Age < 18 or age ≥ 80 years
- GON injection within last 3 months at time of entry into the trial
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Toronto Western Hospital, University Health Network
Toronto, Ontario, M5T 2S8
About this study
Official title: Evaluation of Two Ultrasound-guided Techniques for Greater Occipital Nerve Injections of Local Anesthetic and Steroid for Treatment of Primary Headaches
Headache is one of the most common reasons for patients to access healthcare. Greater occipital nerve (GON) block with local anesthetic and steroid has been described for the management of primary headache refractory to conventional treatment. Two ultrasound (US)-guided techniques for greater occipital nerve (GON) block have been described for the management of refractory headache syndromes: a proximal technique performed at the level of the second cervical vertebra and a distal technique performed at the level of the superior nuchal line. Our airm is to compare the accuracy, efficacy and safety of these two techniques in patients with refractory headaches.
Read the detailed description
We conducted a double-blinded, randomized control trial to compare accuracy, efficacy and safety of these two techniques in patients with refractory headache syndromes. Following REB approval, 40 patients with moderate or severe refractory headaches (intensity score>4/10) will be randomized to the "proximal" or "distal" groups with a 1:1 allocation. Each patient receives an injection of 2ml of 0.5% bupivacaine with 40mg of methylprednisolone. The null hypothesis is that there is no difference in intensity scores for headache at one month after the interventions. Outcomes related to efficacy (numbness immediately after the injection, reduction in episodes of severe headache, sleep quality), performance (time taken for and discomfort during procedure), and safety (incidence of hematoma, intravascular injection) are measured after one month.
- Conditions
- Primary Headache
- Being tested
- US-guided Greater Occipital Nerve Injection
- Keywords
- Primary Headache, Greater Occipital Nerve, Ultrasound, Chronic Pain, Cervicogenic, Occipital Neuralgia, Migraine, Tension type headache, Cluster headache
- Medical subject headings
- Chronic Pain, Migraine Disorders, Tension-Type Headache, Cluster Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US-guided Greater Occipital Nerve InjectionProcedure or surgery
Medication injected around the greater occipital nerve: 2ml 0.5% bupivacaine with epinephrine 1:200,000 and Depo-Medrol 40mg.
| Study group | Role | What they receive |
|---|---|---|
| US-guided Distal GON Block (Group D) | Active comparator | Needle placement for 2ml 0.5% bupivacaine with epinephrine 1:200,000 and Depo-Medrol 40mg will be performed under US guidance at the level of the superior nuchal line lateral to the external occipital protuberance, close to the occipital artery. Receives: Procedure: US-guided Greater Occipital Nerve Injection |
| US-guided Proximal GON Block (Group P) | Active comparator | Needle placement for 2ml 0.5% bupivacaine with epinephrine 1:200,000 and Depo-Medrol 40mg will be performed under US guidance at the level of the bifid C2 spinous process laterally, between the inferior obliquus capitis and semispinalis capitis muscles. Receives: Procedure: US-guided Greater Occipital Nerve Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical rating score (NRS) for headaches
Measured: One month
Secondary outcomes (3)
Efficacy-Related Outcomes
This would include NRS for headache at 24 hrs and 3 months after the intervention, patient satisfaction with the block, Hospital Anxiety and Depression Scale at 1 month compared to baseline, SF-36 Short Form Health Survey to measure improvement in functional status compared to baseline, quality of sleep and average hours of restful sleep at night.
Measured: 24 hours and 3 months
Performance-Related Outcomes
We will measure performance time from contact of US probe with skin to the end of the procedure, procedural discomfort as rated by NRS, number of needle re-adjustments and evidence of sensory block as confirmed by the loss of pin-prick sensation in the dermatomal distribution of GON, and visualization of GON.
Measured: During procedure
Safety-Related Outcomes
Any immediate post intervention complications will be recorded (e.g. hematoma, vascular puncture, dizziness). Occurrence of any long-term adverse effects (e.g. infection, numbness, alopecia) will be recorded at 1 month following the intervention.
Measured: Immediate post-procedure and at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2017
- Study completionMay 2018
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 Primary HeadacheStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anuj Bhatia, MD FRCPC, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02031822
- Sponsor's protocol ID
- 13-6804
- Acronym
- GON
- Status last verified
- Oct 2017
- First submitted
- 7 Jan 2014
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Flamer D, Alakkad H, Soneji N, Tumber P, Peng P, Kara J, Hoydonckx Y, Bhatia A. Comparison of two ultrasound-guided techniques for greater occipital nerve injections in chronic migraine: a double-blind, randomized, controlled trial. Reg Anesth Pain Med. 2019 May;44(5):595-603. doi: 10.1136/rapm-2018-100306. Epub 2019 Mar 18.
PubMed 30886069
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Two Ultrasound-guided Techniques for Greater Occipital Nerve Injections of Local Anesthetic and Steroid for Treatment of Primary Headaches
- ClinicalTrials.gov ID
- NCT02031822
- Acronym / sponsor ID
- GON / 13-6804
- Conditions
- Primary Headache
- Keywords
- Primary Headache, Greater Occipital Nerve, Ultrasound, Chronic Pain, Cervicogenic, Occipital Neuralgia, Migraine, Tension type headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Sep 2017 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 9 Jan 2014 (estimated)
- 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.
Headache is one of the most common reasons for patients to access healthcare. Greater occipital nerve (GON) block with local anesthetic and steroid has been described for the management of primary headache refractory to conventional treatment. Two ultrasound (US)-guided techniques for greater occipital nerve (GON) block have been described for the management of refractory headache syndromes: a proximal technique performed at the level of the second cervical vertebra and a distal technique performed at the level of the superior nuchal line. Our airm is to compare the accuracy, efficacy and safety of these two techniques in patients with refractory headaches.
Detailed description
We conducted a double-blinded, randomized control trial to compare accuracy, efficacy and safety of these two techniques in patients with refractory headache syndromes. Following REB approval, 40 patients with moderate or severe refractory headaches (intensity score>4/10) will be randomized to the "proximal" or "distal" groups with a 1:1 allocation. Each patient receives an injection of 2ml of 0.5% bupivacaine with 40mg of methylprednisolone. The null hypothesis is that there is no difference in intensity scores for headache at one month after the interventions. Outcomes related to efficacy (numbness immediately after the injection, reduction in episodes of severe headache, sleep quality), performance (time taken for and discomfort during procedure), and safety (incidence of hematoma, intravascular injection) are measured after one month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| US-guided Distal GON Block (Group D) | Active comparator | Procedure: US-guided Greater Occipital Nerve InjectionNeedle placement for 2ml 0.5% bupivacaine with epinephrine 1:200,000 and Depo-Medrol 40mg will be performed under US guidance at the level of the superior nuchal line lateral to the external occipital protuberance, close to the occipital artery. |
| US-guided Proximal GON Block (Group P) | Active comparator | Procedure: US-guided Greater Occipital Nerve InjectionNeedle placement for 2ml 0.5% bupivacaine with epinephrine 1:200,000 and Depo-Medrol 40mg will be performed under US guidance at the level of the bifid C2 spinous process laterally, between the inferior obliquus capitis and semispinalis capitis muscles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Features suggestive of occipital neuralgia: pain that begins in the upper neck and back of the head with radiation forward toward the eye and has an aching or burning character.
- Diagnosis of refractory primary headache, any type
- Baseline NRS headache score of > 4 refractory to conventional oral analgesic therapy (anti-inflammatory drugs, migraine prophylaxis and treatment drugs, opioids).
Key exclusion criteria (6 listed)
- Ongoing litigation issues related to the patient's pain
- Pregnancy
- Allergy to steroids or local anesthetics
- Multiple serious comorbidities
- Age < 18 or age ≥ 80 years
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 |
|---|---|---|
| US-guided Greater Occipital Nerve InjectionMedication injected around the greater occipital nerve: 2ml 0.5% bupivacaine with epinephrine 1:200,000 and Depo-Medrol 40mg. | Procedure or surgery | US-guided Distal GON Block (Group D), US-guided Proximal GON Block (Group P) |
Primary outcome
Numerical rating score (NRS) for headaches
Time frame: One month
3 secondary outcomes
Efficacy-Related Outcomes
Time frame: 24 hours and 3 months
Performance-Related Outcomes
Time frame: During procedure
Safety-Related Outcomes
Time frame: Immediate post-procedure and at 1 month
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 30 May 2018.
- Derived from this study: PubMed 30886069Flamer D, Alakkad H, Soneji N, Tumber P, Peng P, Kara J, Hoydonckx Y, Bhatia A. Comparison of two ultrasound-guided techniques for greater occipital nerve injections in chronic migraine: a double-blind, randomized, controlled trial. Reg Anesth Pain Med. 2019 May;44(5):595-603. doi: 10.1136/rapm-2018-100306. Epub 2019 Mar 18.
- 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.
Anuj Bhatia, MD FRCPC principal investigator
University Health Network, Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing US-guided Greater Occipital Nerve Injection in people with Primary Headache, run by University Health Network, Toronto at 2 sites in Canada.
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 6 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 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
Numerical rating score (NRS) for headaches (time frame: One month). 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 NCT02031822, 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 30 May 2018.