A Prospective Controlled Treatment Trial for Post-Traumatic Headaches

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: Recruiting
• Conditions: Post-Traumatic Headaches
• Intervention / Treatment: Drug: Occipital Nerve Block (ONB) using lidocaine and dexamethosone; Drug: Cervical Medial Branch Block (CMBB) using lidocaine and dexamethosone

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: Interventional
• Enrollment (Anticipated): 63
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Pradeep Dinakar, MD; Phone Number: 857-218-3556; Email: Pradeep.Dinakar@childrens.harvard.edu
• Study Contact Backup: Name: Kimberly Lobo, MPH; Phone Number: 857-218-3556; Email: kimberly.lobo@childrens.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Children's Hospital
      • Contact: Kimberly Lobo, MPH; Phone Number: 857-218-3556
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Beth Israel Deaconess Medical Center
      • Contact: Alexandra Stillman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Change in pain intensity scores using the numerical rating scale (NRS)	Baseline, weekly for a period of 2 months from the start of the study, and then bi-weekly for an additional 10 month period (total of 12 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Headache Frequency assessed by Migraine Disability Assessment (MIDAS)	Self-administered questionnaire to quantify headache-related disability	Baseline, weekly for a period of 2 months from the start of the study, and then bi-weekly for an additional 10 month period (total of 12 months)
Headache Frequency assessed by the Pediatric Migraine Disability Assessment (PedMIDAS)	Self-administered questionnaire to quantify headache-related disability	Baseline, weekly for a period of 2 months from the start of the study, and then bi-weekly for an additional 10 month period (total of 12 months)
Headache severity assessed by Migraine Disability Assessment (MIDAS)	Self-administered questionnaire to quantify headache-related disability	Baseline, weekly for a period of 2 months from the start of the study, and then bi-weekly for an additional 10 month period (total of 12 months)
Headache severity assessed by the Pediatric Migraine Disability Assessment (PedMIDAS)	Self-administered questionnaire to quantify headache-related disability	Baseline, weekly for a period of 2 months from the start of the study, and then bi-weekly for an additional 10 month period (total of 12 months)
Functional Disability Scores	Assessed using the Functional Disability Inventory (FDI)	Baseline, weekly for a period of 2 months from the start of the study, and then bi-weekly for an additional 10 month period (total of 12 months)
Quality of Life Assessment assessed by Quality of Life Assessment (QL)	Standardized questionnaire that assess adult patients perceptions of health-related quality of life (HRQOL) with chronic health conditions.	Baseline, weekly for a period of 2 months from the start of the study, and then bi-weekly for an additional 10 month period (total of 12 months)
Quality of Life Assessment assessed by the Pediatric QL (PedsQL)	Standardized questionnaire that assess a pediatric patients/parent's perceptions of health-related quality of life (HRQOL) with chronic health conditions.	Baseline, weekly for a period of 2 months from the start of the study, and then bi-weekly for an additional 10 month period (total of 12 months)

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: Beth Israel Deaconess Medical Center; Harvard University

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2018
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: December 22, 2016
• First Submitted That Met QC Criteria: December 29, 2016
• First Posted (Estimate): January 2, 2017

Study Record Updates

• Last Update Posted (Actual): September 22, 2022
• Last Update Submitted That Met QC Criteria: September 21, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders; Headache Disorders, Secondary; Headache; Post-Traumatic Headache; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID 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