MigrainePhase 4NCT04017741
A Study Investigating the Efficacy of GON Blocks.
A Phase 4 study testing Combined Depo-Medrone and Lidocaine and Sodium Chloride 0.9% Inj in people with Migraine and Chronic Migraine, Headache, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
Greater occipital nerve block ("GON block") is carried out extensively in the treatment of chronic migraine, but more research is required to understand the effectiveness of the procedure. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Migraine, Chronic Migraine, Headache
- What is being tested?
- Combined Depo-Medrone and Lidocaine and Sodium Chloride 0.9% Inj
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Feb 2018to 23 Jan 2020
- Phase
- Phase 4
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged over the age of 18 who are able to provide a written consent
- Ability to read and write English, due to questionnaire use in study
- Diagnosis of chronic migraine with or without acute relief medication overuse (ICHD-III codes 1.3 and 8.2); as confirmed by diary documentation (headache on 15 or more days a month for at least 3 months)
Who cannot join
- Patient refusal
- Participation in any trial of any investigational products or interventional research project within the previous eight weeks to enrolment
- Patients unable to commit to the six-month study duration (PI judgment)
- Any known contraindication(s) to the IMPs as described by the manufacturer's Summary of Product Characteristics (SmPCs)
- Patients with a history of substance abuse
- Pregnant or breastfeeding patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IV Single Blind Placebo-controlled Cross Over Study to Investigate the Efficacy of Greater Occipital Nerve Block With Local Anesthetic and Steroid in Patients With Chronic Migraine
Greater occipital nerve block ("GON block") is carried out extensively in the treatment of chronic migraine, but more research is required to understand the effectiveness of the procedure. It consists of a superficial injection of local anaesthetic and steroid around a nerve at the back of the head that supplies sensation to part of the scalp. This study intends to provide more detailed information on the effectiveness, safety and tolerability of GON block with local anaesthetic and steroid in patients with chronic migraine. It does this by comparing it to a dummy (placebo) procedure (a needle is inserted near the nerve, but no therapeutic substance is injected). It is a "cross-over study": all patients will receive both the GON block and the dummy procedure (not necessarily in that order), with a period in between to assess the response to the first injection. The GON block will entail an injection of 2 mls of 2% lidocaine (a local anaesthetic) and 80 mg of DepoMedrone (a steroid) through a fine needle (a total of 4 mls). The dummy procedure will consist of an injection of 4 mls of normal saline (a solution of common salt and water) through a fine needle. Patients will be followed up at various time points throughout 6 months whilst being enrolled on the study.
Read the detailed description
Chronic migraine is characterised by frequency of headache ≥ 15 days per month for more than 3 months. The location can be unilateral or bilateral. Usually described as pulsating in nature, it may be aggravated by, or cause avoidance of, routine activities of daily living. There can be associated light and noise sensitivity. Greater occipital nerve (GON) blockade with local anaesthetics and steroids has been used as a preventative strategy for a range of headaches including, migraine, cluster headache and hemicrania continua.
The occipital nerves have a sensory distribution in the occipital area. The greater occipital nerve derives most of its fibres from the C2 dorsal root [6]. It passes over the superior nuchal line, mid-way between the mastoid process and the occipital protuberance, just lateral to the insertion of the nuchal ligaments. The lesser occipital nerve passes lateral to the greater occipital nerve, over the nuchal ridge. Although the exact mechanism of action remains unclear, injection of steroid in the vicinity of GON nerve can have both a local effect (decreasing nociception) and a delayed central nociceptive response, possibly through an action on trigeminocervical relay
Although GON block is carried out extensively in the prophylaxis of chronic migraine, the evidence remains equivocal. In the UK, the National Institute for Clinical Excellence have yet to include GON blocks in their guidance and protocols on the treatment of both chronic headache and migraine. This randomised, single-blinded, placebo-controlled multicentre cross-over study intends to assess the efficacy, safety and tolerability of greater occipital nerve block with local anaesthetic and steroid in patients with chronic migraine with the primary objective to investigate any improvement in disability associated with chronic migraine disorder. We also intend to identify any economic outcomes associated with these injections in the management of chronic migraine.
GON block with local anaesthetic and steroid for chronic migraine and the placebo procedure will be performed in the outpatient setting. They will be carried out only by appropriately qualified members of the research team adhering to strict aseptic conditions and following standard operating protocols with regards to admission and discharge criteria in the outpatient settings.
GON block is routinely carried out in the UK and poses minimal risks to the patient. Although GON block is carried out extensively in prophylaxis of chronic migraine, the evidence remains equivocal. In the UK, the National Institute for Health and Care Excellence (NICE) have yet to include GON blocks in their guidance and protocols on the treatment of both chronic headache and migraine.
The aim of this study is to assess the efficacy, safety and tolerability of greater occipital nerve block with local anaesthetic and steroid in patients with chronic migraine of more than three months' duration.
- Conditions
- Migraine, Chronic Migraine, Headache
- Being tested
- Combined Depo-Medrone and Lidocaine, Sodium Chloride 0.9% Inj
- Keywords
- Chronic migraine, GON blocks
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Depo-Medrone and LidocaineDrug
Also called Methylprednisolone Acetate BP 40mg/mL:, Lidocaine Hydrochloride 2%:
Patients will be randomised 1:1 to receive the active or placebo arm. The nerve is located along the superior nuchal line, where it bilaterally lies medial to the occipital artery. The scalp is prepped with alcohol and using 23G needle, the IMPs are injected at a 90 degrees angle till the bony endpoint is obtained. A combination of 2 mls of 2% lidocaine and 80mg methylprednisolone will be administered.
Patients who no longer receive any benefit will be crossed over to the placebo arm.
Sodium Chloride 0.9% InjDrug
Also called normal saline 0.9%
Patients will be randomised 1:1 to receive the active or placebo arm. The nerve is located along the superior nuchal line, where it bilaterally lies medial to the occipital artery. The scalp is prepped with alcohol and using 23G needle the 4mls of normal saline (0.9%) are injected at a 90 degrees angle till the bony endpoint is obtained. Patients who no longer receive any benefit will be crossed over to the active arm.
| Study group | Role | What they receive |
|---|---|---|
| Active group | Active comparator | The active group will be administered 2 mls of 2% lidocaine and 80mg methylprednisolone. Receives: Drug: Combined Depo-Medrone and Lidocaine; Drug: Sodium Chloride 0.9% Inj |
| Placebo group | Placebo comparator | The placebo group will be administered 4mls of 0.9% saline. Receives: Drug: Combined Depo-Medrone and Lidocaine; Drug: Sodium Chloride 0.9% Inj |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes in disability associated with chronic migraine disorder at baseline
The average change in HIT-6 scores which measures six patient self-assessment-questions and helps distinguish the impact the effect of headache and its treatment on the patient's functional status and quality of life.
Measured: Baseline
The changes in baseline headache impact test scores (HIT-6) at 4 weeks
The average change in HIT-6 scores which measures six patient self-assessment-questions and helps distinguish the impact the effect of headache and its treatment on the patient's functional status and quality of life.
Measured: 4 weeks
The changes in baseline headache impact test scores (HIT-6) at 8 weeks
The average change in HIT-6 scores which measures six patient self-assessment-questions and helps distinguish the impact the effect of headache and its treatment on the patient's functional status and quality of life.
Measured: 8 weeks
The changes in baseline headache impact test scores (HIT-6) at 12 weeks
The average change in HIT-6 scores which measures six patient self-assessment-questions and helps distinguish the impact the effect of headache and its treatment on the patient's functional status and quality of life.
Measured: 12 weeks
The changes in baseline headache impact test scores (HIT-6) at 16 weeks
The average change in HIT-6 scores which measures six patient self-assessment-questions and helps distinguish the impact the effect of headache and its treatment on the patient's functional status and quality of life.
Measured: 16 weeks
The changes in baseline headache impact test scores (HIT-6) at 20 weeks
The average change in HIT-6 scores which measures six patient self-assessment-questions and helps distinguish the impact the effect of headache and its treatment on the patient's functional status and quality of life.
Measured: 20 weeks
The changes in baseline headache impact test scores (HIT-6) at 24 weeks
The average change in HIT-6 scores which measures six patient self-assessment-questions and helps distinguish the impact the effect of headache and its treatment on the patient's functional status and quality of life.
Measured: 24 weeks
change in quality of life relating to migraine at baseline
average change MSQ (Migraine Specific Quality of Life Questionnaire) to assess quality of life relating to migraine. MSQ Version 2.1 consists of 14 questions.
Measured: baseline
change in quality of life relating to migraine from baseline at 4 weeks
average change MSQ (Migraine Specific Quality of Life Questionnaire) to assess quality of life relating to migraine. MSQ Version 2.1 consists of 14 questions.
Measured: 4 weeks
change in quality of life relating to migraine from baseline at 8 weeks
average change MSQ (Migraine Specific Quality of Life Questionnaire) to assess quality of life relating to migraine. MSQ Version 2.1 consists of 14 questions.
Measured: 8 weeks
change in quality of life relating to migraine from baseline at 12 weeks
average change MSQ (Migraine Specific Quality of Life Questionnaire) to assess quality of life relating to migraine. MSQ Version 2.1 consists of 14 questions.
Measured: 12 weeks
change in quality of life relating to migraine from baseline at 16 weeks
average change MSQ (Migraine Specific Quality of Life Questionnaire) to assess quality of life relating to migraine. MSQ Version 2.1 consists of 14 questions.
Measured: 16 weeks
change in quality of life relating to migraine from baseline at 20 weeks
average change MSQ (Migraine Specific Quality of Life Questionnaire) to assess quality of life relating to migraine. MSQ Version 2.1 consists of 14 questions.
Measured: 20 weeks
change in quality of life relating to migraine from baseline at 24 weeks
average change MSQ (Migraine Specific Quality of Life Questionnaire) to assess quality of life relating to migraine. MSQ Version 2.1 consists of 14 questions.
Measured: 24 weeks
change in health related quality of life associated with chronic migraine disorder at baseline
The changes reported in the short form survey with 12 questions (SF-12), comprised of two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life.
Measured: baseline
change in health related quality of life associated with chronic migraine disorder from baseline at 4 weeks
The changes reported in the short form survey with 12 questions (SF-12), comprised of two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life.
Measured: 4 weeks
change in health related quality of life associated with chronic migraine disorder from baseline at 8 weeks
The changes reported in the short form survey with 12 questions (SF-12), comprised of two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life.
Measured: 8 weeks
change in health related quality of life associated with chronic migraine disorder from baseline at 12 weeks
The changes reported in the short form survey with 12 questions (SF-12), comprised of two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life.
Measured: 12 weeks
change in health related quality of life associated with chronic migraine disorder from baseline at 16 weeks
The changes reported in the short form survey with 12 questions (SF-12), comprised of two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life.
Measured: 16 weeks
change in health related quality of life associated with chronic migraine disorder from baseline at 20 weeks
The changes reported in the short form survey with 12 questions (SF-12), comprised of two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life.
Measured: 20 weeks
change in health related quality of life associated with chronic migraine disorder from baseline at 24 weeks
The changes reported in the short form survey with 12 questions (SF-12), comprised of two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life.
Measured: 24 weeks
Secondary outcomes (14)
Change in Headache frequency & Severity at baseline
changes in Frequency and severity as scored in the HIT-6 questionnaire. Total scores can range between 36-78. Scores higher than 60 can indicate more greater impact on patient life.
Measured: baseline
Change from baseline Headache frequency & Severity at 4 weeks
changes in Frequency and severity as scored in the HIT-6 questionnaire when compared to baseline. Total scores can range between 36-78. Scores higher than 60 can indicate more greater impact on patient life.
Measured: 4 weeks
Change from baseline Headache frequency & Severity at 8 weeks
changes in Frequency and severity as scored in the HIT-6 questionnaire when compared to baseline. Total scores can range between 36-78. Scores higher than 60 can indicate more greater impact on patient life.
Measured: 8 weeks
Change from baseline Headache frequency & Severity at 12 weeks
changes in Frequency and severity as scored in the HIT-6 questionnaire when compared to baseline. Total scores can range between 36-78. Scores higher than 60 can indicate more greater impact on patient life.
Measured: 12 weeks
Change from baseline Headache frequency & Severity at 16 weeks
changes in Frequency and severity as scored in the HIT-6 questionnaire. Total scores can range between 36-78. Scores higher than 60 can indicate more greater impact on patient life.
Measured: 16 weeks
Change in Headache frequency & Severity at 20 weeks
changes in Frequency and severity as scored in the HIT-6 questionnaire when compared to baseline.Total scores can range between 36-78. Scores higher than 60 can indicate more greater impact on patient life.
Measured: 20 weeks
Change from baseline Headache frequency & Severity at 24 weeks
changes in Frequency and severity as scored in the HIT-6 questionnaire. Total scores can range between 36-78. Scores higher than 60 can indicate more greater impact on patient life.
Measured: 24 weeks
Change in anxiety and depression levels at baseline
Change in Hospital Anxiety and Depression Scores (HADS) questionnaire Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The higher the score, the more impact the headache has on the patient's life.
Measured: baseline
Change from baseline anxiety and depression levels at 4 weeks
Change in Hospital Anxiety and Depression Scores (HADS) questionnaire when compared to baseline. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The higher the score, the more impact the headache has on the patient's life.
Measured: 4 weeks
Change from baseline anxiety and depression levels at 8 weeks
Change in Hospital Anxiety and Depression Scores (HADS) questionnaire when compared to baseline
Measured: 8 weeks
Change from baseline anxiety and depression levels at 12 weeks
Change in Hospital Anxiety and Depression Scores (HADS) questionnaire when compared to baseline. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The higher the score, the more impact the headache has on the patient's life.
Measured: 12 weeks
Change from baseline anxiety and depression levels at 16 weeks
Change in Hospital Anxiety and Depression Scores (HADS) questionnaire when compared to baseline. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The higher the score, the more impact the headache has on the patient's life.
Measured: 16 weeks
Change from baseline anxiety and depression levels at 20 weeks
Change in Hospital Anxiety and Depression Scores (HADS) questionnaire when compared to baseline. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The higher the score, the more impact the headache has on the patient's life.
Measured: 20 weeks
Change from baseline anxiety and depression levels at 24 weeks
Change in Hospital Anxiety and Depression Scores (HADS) questionnaire when compared to baseline. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The higher the score, the more impact the headache has on the patient's life.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start14 Feb 2018
- Primary completion31 Dec 2019
- Study completion23 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Consented participants will be individually randomised by the Principal Investigator (PI) in a 1:1 ratio to receive either the GON block (active group) or the placebo injection (control group).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anish Bahra, Principal investigator, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04017741
- Sponsor's protocol ID
- 009665 BLT
- Status last verified
- Nov 2019
- First submitted
- 16 Apr 2019
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Single Blind Placebo-controlled Cross Over Study to Investigate the Efficacy of Greater Occipital Nerve Block With Local Anesthetic and Steroid in Patients With Chronic Migraine
- ClinicalTrials.gov ID
- NCT04017741
- Acronym / sponsor ID
- 009665 BLT
- Conditions
- Migraine, Chronic Migraine, Headache
- Keywords
- Chronic migraine, GON blocks
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 23 Jan 2020 (actual)
- First posted
- 12 Jul 2019 (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.
Greater occipital nerve block ("GON block") is carried out extensively in the treatment of chronic migraine, but more research is required to understand the effectiveness of the procedure. It consists of a superficial injection of local anaesthetic and steroid around a nerve at the back of the head that supplies sensation to part of the scalp. This study intends to provide more detailed information on the effectiveness, safety and tolerability of GON block with local anaesthetic and steroid in patients with chronic migraine. It does this by comparing it to a dummy (placebo) procedure (a needle is inserted near the nerve, but no therapeutic substance is injected). It is a "cross-over study": all patients will receive both the GON block and the dummy procedure (not necessarily in that order), with a period in between to assess the response to the first injection. The GON block will entail an injection of 2 mls of 2% lidocaine (a local anaesthetic) and 80 mg of DepoMedrone (a steroid) through a fine needle (a total of 4 mls). The dummy procedure will consist of an injection of 4 mls of normal saline (a solution of common salt and water) through a fine needle. Patients will be followed up at various time points throughout 6 months whilst being enrolled on the study.
Detailed description
Chronic migraine is characterised by frequency of headache ≥ 15 days per month for more than 3 months. The location can be unilateral or bilateral. Usually described as pulsating in nature, it may be aggravated by, or cause avoidance of, routine activities of daily living. There can be associated light and noise sensitivity. Greater occipital nerve (GON) blockade with local anaesthetics and steroids has been used as a preventative strategy for a range of headaches including, migraine, cluster headache and hemicrania continua.
The occipital nerves have a sensory distribution in the occipital area. The greater occipital nerve derives most of its fibres from the C2 dorsal root [6]. It passes over the superior nuchal line, mid-way between the mastoid process and the occipital protuberance, just lateral to the insertion of the nuchal ligaments. The lesser occipital nerve passes lateral to the greater occipital nerve, over the nuchal ridge. Although the exact mechanism of action remains unclear, injection of steroid in the vicinity of GON nerve can have both a local effect (decreasing nociception) and a delayed central nociceptive response, possibly through an action on trigeminocervical relay
Although GON block is carried out extensively in the prophylaxis of chronic migraine, the evidence remains equivocal. In the UK, the National Institute for Clinical Excellence have yet to include GON blocks in their guidance and protocols on the treatment of both chronic headache and migraine. This randomised, single-blinded, placebo-controlled multicentre cross-over study intends to assess the efficacy, safety and tolerability of greater occipital nerve block with local anaesthetic and steroid in patients with chronic migraine with the primary objective to investigate any improvement in disability associated with chronic migraine disorder. We also intend to identify any economic outcomes associated with these injections in the management of chronic migraine.
GON block with local anaesthetic and steroid for chronic migraine and the placebo procedure will be performed in the outpatient setting. They will be carried out only by appropriately qualified members of the research team adhering to strict aseptic conditions and following standard operating protocols with regards to admission and discharge criteria in the outpatient settings.
GON block is routinely carried out in the UK and poses minimal risks to the patient. Although GON block is carried out extensively in prophylaxis of chronic migraine, the evidence remains equivocal. In the UK, the National Institute for Health and Care Excellence (NICE) have yet to include GON blocks in their guidance and protocols on the treatment of both chronic headache and migraine.
The aim of this study is to assess the efficacy, safety and tolerability of greater occipital nerve block with local anaesthetic and steroid in patients with chronic migraine of more than three months' duration.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Consented participants will be individually randomised by the Principal Investigator (PI) in a 1:1 ratio to receive either the GON block (active group) or the placebo injection (control group).
| Arm | Type | Receives |
|---|---|---|
| Active group | Active comparator | Drug: Combined Depo-Medrone and Lidocaine, Drug: Sodium Chloride 0.9% InjThe active group will be administered 2 mls of 2% lidocaine and 80mg methylprednisolone. |
| Placebo group | Placebo comparator | Drug: Combined Depo-Medrone and Lidocaine, Drug: Sodium Chloride 0.9% InjThe placebo group will be administered 4mls of 0.9% saline. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged over the age of 18 who are able to provide a written consent
- Ability to read and write English, due to questionnaire use in study
- Diagnosis of chronic migraine with or without acute relief medication overuse (ICHD-III codes 1.3 and 8.2); as confirmed by diary documentation (headache on 15 or more days a month for at least 3 months)
Key exclusion criteria (6 listed)
- Patient refusal
- Participation in any trial of any investigational products or interventional research project within the previous eight weeks to enrolment
- Patients unable to commit to the six-month study duration (PI judgment)
- Any known contraindication(s) to the IMPs as described by the manufacturer's Summary of Product Characteristics (SmPCs)
- Patients with a history of substance abuse
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 |
|---|---|---|
| Combined Depo-Medrone and LidocaineAlso: Methylprednisolone Acetate BP 40mg/mL:, Lidocaine Hydrochloride 2%:Patients will be randomised 1:1 to receive the active or placebo arm. The nerve is located along the superior nuchal line, where it bilaterally lies medial to the occipital artery. The scalp is prepped with alcohol and using 23G needle, the IMPs are injected at a 90 degrees angle till the bony endpoint is obtained. A combination of 2 mls of 2% lidocaine and 80mg methylprednisolone will be administered. Patients who no longer receive any benefit will be crossed over to the placebo arm. | Drug | Active group, Placebo group |
| Sodium Chloride 0.9% InjAlso: normal saline 0.9%Patients will be randomised 1:1 to receive the active or placebo arm. The nerve is located along the superior nuchal line, where it bilaterally lies medial to the occipital artery. The scalp is prepped with alcohol and using 23G needle the 4mls of normal saline (0.9%) are injected at a 90 degrees angle till the bony endpoint is obtained. Patients who no longer receive any benefit will be crossed over to the active arm. | Drug | Active group, Placebo group |
Primary outcome
The changes in disability associated with chronic migraine disorder at baseline
Time frame: Baseline
The average change in HIT-6 scores which measures six patient self-assessment-questions and helps distinguish the impact the effect of headache and its treatment on the patient's functional status and quality of life.
The changes in baseline headache impact test scores (HIT-6) at 4 weeks
Time frame: 4 weeks
The average change in HIT-6 scores which measures six patient self-assessment-questions and helps distinguish the impact the effect of headache and its treatment on the patient's functional status and quality of life.
The changes in baseline headache impact test scores (HIT-6) at 8 weeks
Time frame: 8 weeks
The average change in HIT-6 scores which measures six patient self-assessment-questions and helps distinguish the impact the effect of headache and its treatment on the patient's functional status and quality of life.
The changes in baseline headache impact test scores (HIT-6) at 12 weeks
Time frame: 12 weeks
The average change in HIT-6 scores which measures six patient self-assessment-questions and helps distinguish the impact the effect of headache and its treatment on the patient's functional status and quality of life.
The changes in baseline headache impact test scores (HIT-6) at 16 weeks
Time frame: 16 weeks
The average change in HIT-6 scores which measures six patient self-assessment-questions and helps distinguish the impact the effect of headache and its treatment on the patient's functional status and quality of life.
The changes in baseline headache impact test scores (HIT-6) at 20 weeks
Time frame: 20 weeks
The average change in HIT-6 scores which measures six patient self-assessment-questions and helps distinguish the impact the effect of headache and its treatment on the patient's functional status and quality of life.
The changes in baseline headache impact test scores (HIT-6) at 24 weeks
Time frame: 24 weeks
The average change in HIT-6 scores which measures six patient self-assessment-questions and helps distinguish the impact the effect of headache and its treatment on the patient's functional status and quality of life.
change in quality of life relating to migraine at baseline
Time frame: baseline
average change MSQ (Migraine Specific Quality of Life Questionnaire) to assess quality of life relating to migraine. MSQ Version 2.1 consists of 14 questions.
change in quality of life relating to migraine from baseline at 4 weeks
Time frame: 4 weeks
average change MSQ (Migraine Specific Quality of Life Questionnaire) to assess quality of life relating to migraine. MSQ Version 2.1 consists of 14 questions.
change in quality of life relating to migraine from baseline at 8 weeks
Time frame: 8 weeks
average change MSQ (Migraine Specific Quality of Life Questionnaire) to assess quality of life relating to migraine. MSQ Version 2.1 consists of 14 questions.
change in quality of life relating to migraine from baseline at 12 weeks
Time frame: 12 weeks
average change MSQ (Migraine Specific Quality of Life Questionnaire) to assess quality of life relating to migraine. MSQ Version 2.1 consists of 14 questions.
change in quality of life relating to migraine from baseline at 16 weeks
Time frame: 16 weeks
average change MSQ (Migraine Specific Quality of Life Questionnaire) to assess quality of life relating to migraine. MSQ Version 2.1 consists of 14 questions.
change in quality of life relating to migraine from baseline at 20 weeks
Time frame: 20 weeks
average change MSQ (Migraine Specific Quality of Life Questionnaire) to assess quality of life relating to migraine. MSQ Version 2.1 consists of 14 questions.
change in quality of life relating to migraine from baseline at 24 weeks
Time frame: 24 weeks
average change MSQ (Migraine Specific Quality of Life Questionnaire) to assess quality of life relating to migraine. MSQ Version 2.1 consists of 14 questions.
change in health related quality of life associated with chronic migraine disorder at baseline
Time frame: baseline
The changes reported in the short form survey with 12 questions (SF-12), comprised of two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life.
change in health related quality of life associated with chronic migraine disorder from baseline at 4 weeks
Time frame: 4 weeks
The changes reported in the short form survey with 12 questions (SF-12), comprised of two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life.
change in health related quality of life associated with chronic migraine disorder from baseline at 8 weeks
Time frame: 8 weeks
The changes reported in the short form survey with 12 questions (SF-12), comprised of two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life.
change in health related quality of life associated with chronic migraine disorder from baseline at 12 weeks
Time frame: 12 weeks
The changes reported in the short form survey with 12 questions (SF-12), comprised of two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life.
change in health related quality of life associated with chronic migraine disorder from baseline at 16 weeks
Time frame: 16 weeks
The changes reported in the short form survey with 12 questions (SF-12), comprised of two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life.
change in health related quality of life associated with chronic migraine disorder from baseline at 20 weeks
Time frame: 20 weeks
The changes reported in the short form survey with 12 questions (SF-12), comprised of two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life.
change in health related quality of life associated with chronic migraine disorder from baseline at 24 weeks
Time frame: 24 weeks
The changes reported in the short form survey with 12 questions (SF-12), comprised of two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life.
14 secondary outcomes
Change in Headache frequency & Severity at baseline
Time frame: baseline
Change from baseline Headache frequency & Severity at 4 weeks
Time frame: 4 weeks
Change from baseline Headache frequency & Severity at 8 weeks
Time frame: 8 weeks
Change from baseline Headache frequency & Severity at 12 weeks
Time frame: 12 weeks
Change from baseline Headache frequency & Severity at 16 weeks
Time frame: 16 weeks
Change in Headache frequency & Severity at 20 weeks
Time frame: 20 weeks
Change from baseline Headache frequency & Severity at 24 weeks
Time frame: 24 weeks
Change in anxiety and depression levels at baseline
Time frame: baseline
Change from baseline anxiety and depression levels at 4 weeks
Time frame: 4 weeks
Change from baseline anxiety and depression levels at 8 weeks
Time frame: 8 weeks
Change from baseline anxiety and depression levels at 12 weeks
Time frame: 12 weeks
Change from baseline anxiety and depression levels at 16 weeks
Time frame: 16 weeks
Change from baseline anxiety and depression levels at 20 weeks
Time frame: 20 weeks
Change from baseline anxiety and depression levels at 24 weeks
Time frame: 24 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 27 Mar 2020.
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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.
Anish Bahra principal investigator
University College London Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Combined Depo-Medrone and Lidocaine and Sodium Chloride 0.9% Inj in people with Migraine and Chronic Migraine, Headache, run by Barts & The London NHS Trust at 1 site in United Kingdom.
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 27 Mar 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 United Kingdom. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The changes in disability associated with chronic migraine disorder at baseline (time frame: Baseline). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2020.