A Prospective Controlled Treatment Trial for Post-Traumatic Headaches

September 24, 2025 updated by: Pradeep Dinakar, MD, MS, FAAP, Boston Children's Hospital

Post-traumatic headaches (PTH) are the most common complaint after traumatic brain injury, possibly generated by a number of stressors to the trigeminovascular and cervical plexus networks, including inflammation of the high cervical facet joints, traumatic cranial neuralgias, migraines, and myofascial injuries. To date, no treatment guidelines exist for PTH management except for conservative modalities, such as cognitive rest, physical therapy, and neuropathic pain medications, all of which have minimal evidence to support them.

The investigators propose a randomized, controlled, clinical trial and prospective follow-up study to evaluate the effect of invasive procedures such as occipital nerve block (ONB) and cervical medial branch block (CMBB) in the management of PTH.

Adolescents and adults (14-45 years of age) will be recruited from Boston Children's Hospital and Beth Israel Deaconess Medical Center Pain clinics, Concussion clinics and Headache clinics.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Headaches and neck pain following a concussion are potentially treatable and resolve over time. Nerve blockade may enhance the recovery of appropriate neural circuits involved in the pathophysiology of a chronic headache. Currently, no evidence-based guidelines exist for treatment of PTH. Adoption of "brain rest" for 1-2 weeks, followed by gradual return to activity and avoiding "second-impact syndrome" are current practice. The use of medications controlling neuropathic pain is of partial benefit for some. Adverse effects like sedation, mood changes, cardiac side effects of pharmacologic agents are often not compatible with the demands of athletics. For those patients where sports performance is paramount, they may therefore not be able to tolerate regular medications. The incidence of chronic post-concussive headaches (> 3 months) at one year is 8.4% - 35% and at four years is up to 25%. Therefore, patients can have a significant disability from their post-traumatic headaches for many years after their injury. Without appropriate treatment, these headaches can remain as chronic headaches. Over-the-counter and other symptomatic medication overuse can exacerbate and prolong PTH significantly, secondary to rebound headaches. Successful treatment is essential since PTH limits return to sports as well as more general activities of living, such as work and school. Most interventions currently in use partially help and take several weeks to months for a noticeable benefit. PTH interventions, including ONB and CMBB, are employed in the treatment of primary headache disorders and neck pain from cervical arthritis and may provide more improved, faster and more sustained pain relief in many patients. Also, given that most of the action of the nerve blocks is local, there are significantly fewer side effects than in more standard headache medications. Injections that use corticosteroids may be beneficial in a post-traumatic headache by reducing inflammation and therefore mechanical allodynia. Injection of corticosteroids in the cervical facet joint area has shown up to 13 months of pain relief. This prolonged effect may be secondary to central pain modulation. Ultimately, nerve blocks may be a more effective and efficient post-traumatic headache given the onset of effect and the minimal side effects.

To date, there have been no prospective studies of procedural treatments for medically refractory PTH and none in the adolescent and young adult population in whom football injuries are common. Despite the frequent clinical practice of using ONB and CMBB for occipital neuralgia, cervical arthritis, and cervicogenic headaches, there has been no adequate scientific investigation into the use of these interventions for PTH. Given that PTH is typically felt to be secondary to an inflammatory reaction to trauma, the use of injection of corticosteroids may be more effective in PTH than in common headache disorders.

The investigators propose a randomized, prospective, controlled treatment trial to evaluate the efficacy of minimally invasive nerve block interventions (ONB and CMBB) as treatments for PTH and neck pain in adolescents and adults aged 14-45 years of age with PTH.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 14 - 45 years
  • History of post-traumatic headache or neck pain following a concussion or head injury within the last 12 months
  • Self-reported lack of meaningful benefit with at least one previous treatment trial. Previous treatment could include a migraine prophylactic medication, a neuropathic pain medication, a physical intervention, or a cognitive-behavioral intervention.

Exclusion Criteria:

  • Significant underlying psychological concerns, as determined by study psychologist up on review of standardized assessment
  • Lack of parental consent and child assent (if patient age <18 years) or lack of consent (if patient age >18 years). Unable to complete the questionnaire, based on parental or patient estimation of cognitive or language limitations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Occipital Nerve Block

After enrollment in the study, patients will be randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. These are injections of anti-inflammatory medications (steroids) and numbing medications (local anesthetics -lidocaine) in nerves located at the back of the head and neck. If patients exhibit a > or = 50% pain reduction on receiving the block evaluated after four weeks, then they may continue to receive blocks as needed, but not more than one every three months.

If patients exhibit < 50% pain reduction, the patient will be treated as per the clinician's judgment with the possibility of a cross over to the other treatment option.
Drug: Occipital Nerve Block (ONB) using lidocaine and dexamethosone
Patients enrolled in the study will be randomized to receive either an ONB or a CMBB. The assignment of the procedure will be randomized however neither the patients nor the investigator will be blinded to the procedure. Patients randomized to receive an ONB will receive the block with dexamethasone 2mg (steroid) each site with 3ml 1% lidocaine (local anesthetic), for a total of two sites.
Experimental: Cervical Medial Branch Block

After enrollment in the study, patients will be randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. These are injections of anti-inflammatory medications (steroids) and numbing medications (local anesthetics -lidocaine) in nerves located at the back of the head and neck. If patients exhibit a > or = 50% pain reduction on receiving the block evaluated after four weeks, then they may continue to receive blocks as needed, but not more than one every three months.

If patients exhibit < 50% pain reduction the patient will be treated as per the clinician's judgment with the possibility of a cross over to the other treatment option.
Drug: Cervical Medial Branch Block (CMBB) using lidocaine and dexamethosone
Patients enrolled in the study will be randomized to receive either an ONB or a CMBB. The assignment of the procedure will be randomized however neither the patients nor the investigator will be blinded to the procedure. Patients randomized to receive CMBB will receive the block with dexamethasone 1.5mg (steroid) each site with 2 ml 1% lidocaine (local anesthetic), for a total of three sites on each side.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Score
Time Frame: One week, 1 month, 2 months, 3 months, 6months, 9 months, 12 months post-procedure
Pain intensity was rated using the Numerical Rating Scale (NRS) of 0 to 10, with 0 indicating 'no pain' and 10 indicating the 'worst pain imaginable'.
One week, 1 month, 2 months, 3 months, 6months, 9 months, 12 months post-procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Migraine Disability Assessed Using the Migraine Disability Assessment (MIDAS)
Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months

The Migraine Disability Assessment (MIDAS) is a self-administered standardized questionnaire to quantify headache-related disability.

The MIDAS score ranges from 0 to 270. The higher the score on the MIDAS questionnaire, the greater the disability caused by headaches.
Baseline, 3 months, 6 months, 9 months, 12 months
Pediatric Migraine Disability Assessment (PedMIDAS)
Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months

The Pediatric Migraine Disability Assessment (PedsMIDAS) is a self-administered standardized questionnaire to quantify headache related disability.

The PedsMIDAS score ranges from 0 to 240. The higher the score on the PedsMIDAS questionnaire, the greater the disability caused by headaches.
Baseline, 3 months, 6 months, 9 months, 12 months
Headache Severity Assessed by Migraine Disability Assessment (MIDAS)
Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months

Self-administered questionnaire to quantify headache-severity using the following question:

On a scale of 0 - 10, on average how painful were these headaches? (where 0=no pain at all, and 10=pain as bad as it can be)
Baseline, 3 months, 6 months, 9 months, 12 months
Headache Severity Assessed by the Pediatric Migraine Disability Assessment (PedMIDAS)
Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months
Self-administered questionnaire to quantify headache-related disability
Baseline, 3 months, 6 months, 9 months, 12 months
Functional Disability Inventory Scores (FDI)
Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months

The Functional Disability Inventory (FDI) was used to assess functional disability.

The FDI is scored by summing the ratings for each of its 15 items, with scores ranging from 0 to 60.

Higher scores indicate greater perceived functional disability.
Baseline, 3 months, 6 months, 9 months, 12 months
Pain Disability Index (PDI)
Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months

The Pain Disability Index (PDI) was used to assess functional disability in adults.

The PDI is scored by summing the ratings of seven different life domains, each scored on a scale of 0 to 10, with higher scores indicating greater pain-related disability.

The total score can range from 0 to 70. A higher score reflects a greater impact of pain on daily activities.
Baseline, 3 months, 6 months, 9 months, 12 months
World Health Organization Quality of Life - Brief Assessment (WHOQOL-BREF)
Time Frame: Baseline, 2 months, 3 months, 6 months, 9 months, 12 months
The WHOQOL-BREF produces four domain scores (Physical health, Psychological, Social Relationships, and Environment) and two overall items (overall quality of life and general health). The scores range from 4-20 with higher scores indicating a better quality of life.
Baseline, 2 months, 3 months, 6 months, 9 months, 12 months
Pediatric Quality of Life Assessment (PedsQL)
Time Frame: Baseline, 2 months, 3 months, 6 months, 9 months, 12 months post procedure

The Pediatric Quality of Life Assessment (PedsQL) is a standardized questionnaire that assesses a pediatric patient's perceptions of health-related quality of life (HRQOL) with chronic health conditions using 4 domains (Physical, Emotional, Social, School Functioning).

PedsQL scores range from 0-100 where higher scores indicate better health-related quality of life.
Baseline, 2 months, 3 months, 6 months, 9 months, 12 months post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Children's Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Beth Israel Deaconess Medical Center
Harvard University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 2, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 14, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 14, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 29, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 2, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-P00025021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The investigators do not plan to share any IPD collected during the study with other researchers not included in the protocol.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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