A Prospective Controlled Treatment Trial for Post-Traumatic Headaches

NCT ID: NCT03007420

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-02
• Study Completion Date: 2024-06-14

Brief Summary

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.

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.

Conditions

Post-Traumatic Headaches

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Occipital Nerve Block (ONB) using lidocaine and dexamethosone

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Cervical Medial Branch Block (CMBB) using lidocaine and dexamethosone

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: collaborator

Harvard University

OTHER

Sponsor Role: collaborator

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Pradeep Dinakar, MD, MS, FAAP

Assistant Professor of Anesthesiology, Harvard Medical School; Staff Physician, Boston Children's Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Boston Children's Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB-P00025021

Identifier Type: -

Identifier Source: org_study_id