Headache Disorders, PrimaryPhase 2NCT04109885
Paracervical Injection for Headache in the Emergency Department
A Phase 2 study testing Paracervical injection and prochlorperazine and diphenhydramine.(Standard Treatment) in people with Headache Disorders, Primary and Pain Management, run by Christian Fromm, MD at 1 site in United States.
Trial summary
Headache is one of the most common presenting complaints in the emergency department.1 By the time patients with benign headaches present for treatment in the ED, they often have exhausted non-invasive treatments, and physicians are left with few therapeutic options. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Headache Disorders, Primary, Pain Management, Emergency Department
- What is being tested?
- Paracervical injection and prochlorperazine and diphenhydramine.(Standard Treatment)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2020to 30 Jan 2024
- Phase
- Phase 2
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 64 years
- Suspected diagnosis of benign or primary headache
Who cannot join
- Treating attending physician is suspicious of a serious secondary cause of headache
- History of brain disease, concussion, stroke, intracranial mass or tumor, hemorrhage, increased intracranial pressure, head trauma in last 2 weeks, status post intracranial surgery
- History of neck disease, cervical spine or disc abnormality, history of vertebral or carotid artery dissection, torticollis, status post cervical spine surgery or hardware in place
- Hypersensitivity or allergy to bupivacaine (amide anesthetics) or prochlorperazine (dopamine receptor antagonists)
- Overlying signs of infection at site of injection (erythema, purulence, open skin)
- History of extrapyramidal symptoms, dystonia, parkinsonism, tardive dyskinesia or neuroleptic malignant syndrome
Show all 13Show fewer
- Pregnancy
- History of schizophrenia or bipolar disorder
- Narcotic seeking patients as determined by the treating attending physician with optional assistance from medical record and online database review
- Weight more than 150 kg or less than 40 kg
- Received pain medication in the ED or less than 6 hours prior to enrollment
- Temperature greater than 38 degrees Celcius
- Previous enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141
About this study
Official title: Intramuscular Paracervical Injection for Headache in the Emergency Department: A Randomized Controlled Trial
Headache is one of the most common presenting complaints in the emergency department.1 By the time patients with benign headaches present for treatment in the ED, they often have exhausted non-invasive treatments, and physicians are left with few therapeutic options. The investigators therefore propose to study the use of paracervical injection as a novel approach to managing headache in the emergency department. This procedure has great potential, if efficacious, to provide a safe, rapidly effective, non-sedating treatment for headache that does not involve intravenous line placement and systemic medication administration. To date, there are no published trials that evaluate this technique in this setting. The investigators intend to compare the efficacy of paracervical injection to standard first-line therapy (intravenous prochlorperazine and diphenhydramine) for the treatment of benign headache of any etiology in the emergency department.
Read the detailed description
Headache is one of the most common presenting complaints in the emergency department.1 By the time patients with benign headaches present for treatment in the ED, they often have exhausted non-invasive treatments, and physicians are left with few therapeutic options.
Amongst the array of medications used by physicians to manage benign headache, dopamine antagonists have demonstrated the best efficacy in trials. A number of studies have demonstrated the efficacy of dopamine antagonists in treating migraine, tension, cluster-type, and other benign headaches2,3 Dopamine antagonists have shown superiority over opioids4, non-steroidal anti-inflammatory drugs5, triptans6, and anti-epileptics7. Prochlorperazine is probably the most studied and most commonly clinically utilized in this regard in the ED setting.
Despite the preponderance of evidence supporting the use of dopamine antagonists as first-line therapeutic agents in the ED management of benign headache, more than half of the 1.2 million patients treated in U.S. emergency departments for acute migraine are treated with opioids despite the known risks and recommendations to the contrary.12 In addition, there is tremendous variation in the medications chosen by ED physicians for managing benign headache.13 Most of these regimens involve administration of systemic medications that have considerable side effect profiles. Moreover, many of these headache cocktails require prolonged durations of treatment with sedative side effects. This results in prolonged ED lengths of stay that occupy valuable bed space in increasingly busy and crowded emergency departments.
A less well-known approach to managing benign headache is bilateral, paracervical, intramuscular injection of a long-acting anesthetic. The mechanism of action is not entirely understood, however it is postulated to involve neuronal pathways in the trigeminocervical complex thought to play a central role in headache physiology. This is similar in concept to the mechanism proposed for the occipital nerve blocks performed by neurologists.
Paracervical injection was first described by Mellick et al.8 This method has the advantage of ease of administration, favorable safety profile, lack of need for intravenous access, lack of sedative side effects, and swiftness of therapeutic response. In Mellick's case series, he treated 417 patients who presented with all manner of benign headaches with a 65% rate of complete relief of pain and a 20% rate of partial relief. Many patients had rapid relief of headache within 5 minutes and the remainder in less than 30 minutes. This study was limited by possible selection bias, given it is unclear why the specific patients enrolled were chosen for this treatment. The study was also limited by its observational nature and lack of a control group.
In recent years this procedure has gained popularity amongst emergency physicians, and it has been widely discussed in emergency medicine blogs and podcasts. Numerous online videos demonstrate the ease with which the procedure is performed by physicians and tolerated by patients. Many physicians have called for clinical trials to assess its efficacy.
The investigators therefore propose to study the use of paracervical injection as a novel approach to managing headache in the emergency department. This procedure has great potential, if efficacious, to provide a safe, rapidly effective, non-sedating treatment for headache that does not involve intravenous line placement and systemic medication administration. To date, there are no published trials that evaluate this technique in this setting. The investigators intend to compare the efficacy of paracervical injection to standard first-line therapy (intravenous prochlorperazine and diphenhydramine) for the treatment of benign headache of any etiology in the emergency department.
- Being tested
- Paracervical injection, prochlorperazine and diphenhydramine.(Standard Treatment)
- Medical subject headings
- Headache Disorders, Primary, Agnosia, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paracervical injectionDrug
1.5 mL of 0.5% bupivacaine will be will be injected bilaterally in the paraspinal musculature of the cervical spine.
prochlorperazine and diphenhydramine.(Standard Treatment)Drug
Intravenous administration of prochlorperazine and diphenhydramine.
| Study group | Role | What they receive |
|---|---|---|
| Paracervical injection | Experimental | 1.5 mL of 0.5% bupivacaine will be will be injected bilaterally in the paraspinal musculature of the cervical spine. Receives: Drug: Paracervical injection |
| Standard treatment | Active comparator | Intravenous administration of prochlorperazine and diphenhydramine. Receives: Drug: prochlorperazine and diphenhydramine.(Standard Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of symptom improvement
Patient asked if symptoms are improved enough for patient to be discharged to home.
Measured: 30 minutes
Secondary outcomes (3)
Reduction in pain scale
Pain scale measurement (1-10)
Measured: 30 minutes
Re-presentation for medical care
Patient asked if re-presented for medical care in the previous 72 hours (yes/no)
Measured: 72 hours
Headache recurrence
Patient asked if headache recurred (yes/no)
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start15 Sep 2020
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
Why it stopped: Insufficient recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Headache Disorders, PrimaryStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christian Fromm, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christian Fromm, MD, Albert Einstein Healthcare Network
- Investigators
- Christian Fromm, MD, Principal investigator, Einstein Healthcare Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04109885
- Sponsor's protocol ID
- 2019-173
- Status last verified
- Jul 2024
- First submitted
- 27 Sep 2019
- Last updated
- 1 Aug 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intramuscular Paracervical Injection for Headache in the Emergency Department: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04109885
- Acronym / sponsor ID
- 2019-173
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Christian Fromm, MDUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 1 Oct 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.
Headache is one of the most common presenting complaints in the emergency department.1 By the time patients with benign headaches present for treatment in the ED, they often have exhausted non-invasive treatments, and physicians are left with few therapeutic options. The investigators therefore propose to study the use of paracervical injection as a novel approach to managing headache in the emergency department. This procedure has great potential, if efficacious, to provide a safe, rapidly effective, non-sedating treatment for headache that does not involve intravenous line placement and systemic medication administration. To date, there are no published trials that evaluate this technique in this setting. The investigators intend to compare the efficacy of paracervical injection to standard first-line therapy (intravenous prochlorperazine and diphenhydramine) for the treatment of benign headache of any etiology in the emergency department.
Detailed description
Headache is one of the most common presenting complaints in the emergency department.1 By the time patients with benign headaches present for treatment in the ED, they often have exhausted non-invasive treatments, and physicians are left with few therapeutic options.
Amongst the array of medications used by physicians to manage benign headache, dopamine antagonists have demonstrated the best efficacy in trials. A number of studies have demonstrated the efficacy of dopamine antagonists in treating migraine, tension, cluster-type, and other benign headaches2,3 Dopamine antagonists have shown superiority over opioids4, non-steroidal anti-inflammatory drugs5, triptans6, and anti-epileptics7. Prochlorperazine is probably the most studied and most commonly clinically utilized in this regard in the ED setting.
Despite the preponderance of evidence supporting the use of dopamine antagonists as first-line therapeutic agents in the ED management of benign headache, more than half of the 1.2 million patients treated in U.S. emergency departments for acute migraine are treated with opioids despite the known risks and recommendations to the contrary.12 In addition, there is tremendous variation in the medications chosen by ED physicians for managing benign headache.13 Most of these regimens involve administration of systemic medications that have considerable side effect profiles. Moreover, many of these headache cocktails require prolonged durations of treatment with sedative side effects. This results in prolonged ED lengths of stay that occupy valuable bed space in increasingly busy and crowded emergency departments.
A less well-known approach to managing benign headache is bilateral, paracervical, intramuscular injection of a long-acting anesthetic. The mechanism of action is not entirely understood, however it is postulated to involve neuronal pathways in the trigeminocervical complex thought to play a central role in headache physiology. This is similar in concept to the mechanism proposed for the occipital nerve blocks performed by neurologists.
Paracervical injection was first described by Mellick et al.8 This method has the advantage of ease of administration, favorable safety profile, lack of need for intravenous access, lack of sedative side effects, and swiftness of therapeutic response. In Mellick's case series, he treated 417 patients who presented with all manner of benign headaches with a 65% rate of complete relief of pain and a 20% rate of partial relief. Many patients had rapid relief of headache within 5 minutes and the remainder in less than 30 minutes. This study was limited by possible selection bias, given it is unclear why the specific patients enrolled were chosen for this treatment. The study was also limited by its observational nature and lack of a control group.
In recent years this procedure has gained popularity amongst emergency physicians, and it has been widely discussed in emergency medicine blogs and podcasts. Numerous online videos demonstrate the ease with which the procedure is performed by physicians and tolerated by patients. Many physicians have called for clinical trials to assess its efficacy.
The investigators therefore propose to study the use of paracervical injection as a novel approach to managing headache in the emergency department. This procedure has great potential, if efficacious, to provide a safe, rapidly effective, non-sedating treatment for headache that does not involve intravenous line placement and systemic medication administration. To date, there are no published trials that evaluate this technique in this setting. The investigators intend to compare the efficacy of paracervical injection to standard first-line therapy (intravenous prochlorperazine and diphenhydramine) for the treatment of benign headache of any etiology in the emergency department.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paracervical injection | Experimental | Drug: Paracervical injection1.5 mL of 0.5% bupivacaine will be will be injected bilaterally in the paraspinal musculature of the cervical spine. |
| Standard treatment | Active comparator | Drug: prochlorperazine and diphenhydramine.(Standard Treatment)Intravenous administration of prochlorperazine and diphenhydramine. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18 to 64 years
- Suspected diagnosis of benign or primary headache
Key exclusion criteria (13 listed)
- Treating attending physician is suspicious of a serious secondary cause of headache
- History of brain disease, concussion, stroke, intracranial mass or tumor, hemorrhage, increased intracranial pressure, head trauma in last 2 weeks, status post intracranial surgery
- History of neck disease, cervical spine or disc abnormality, history of vertebral or carotid artery dissection, torticollis, status post cervical spine surgery or hardware in place
- Hypersensitivity or allergy to bupivacaine (amide anesthetics) or prochlorperazine (dopamine receptor antagonists)
- Overlying signs of infection at site of injection (erythema, purulence, open skin)
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 |
|---|---|---|
| Paracervical injection1.5 mL of 0.5% bupivacaine will be will be injected bilaterally in the paraspinal musculature of the cervical spine. | Drug | Paracervical injection |
| prochlorperazine and diphenhydramine.(Standard Treatment)Intravenous administration of prochlorperazine and diphenhydramine. | Drug | Standard treatment |
Primary outcome
Rate of symptom improvement
Time frame: 30 minutes
Patient asked if symptoms are improved enough for patient to be discharged to home.
3 secondary outcomes
Reduction in pain scale
Time frame: 30 minutes
Re-presentation for medical care
Time frame: 72 hours
Headache recurrence
Time frame: 72 hours
Results and safety
The study was stopped early (reason given: Insufficient recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- 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.
Christian Fromm, MD principal investigator
Einstein Healthcare Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paracervical injection and prochlorperazine and diphenhydramine.(Standard Treatment) in people with Headache Disorders, Primary and Pain Management, run by Christian Fromm, MD at 1 site in United States.
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 2 inclusion and 13 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: stopped early, as of the sponsor's last update on 1 Aug 2024. 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 States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Insufficient recruitment.). Results are not available in the source record.
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?
Rate of symptom improvement (time frame: 30 minutes). 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 1 Aug 2024.