10 Participants Needed

Nerve Blocks for Post-Traumatic Headache

Recruiting at 1 trial location
PD
KL
Overseen ByKimberly Lobo, MPH
Age: < 65
Sex: Any
Trial Phase: Phase 3
Sponsor: Boston Children's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adolescents and adults aged 14-45 who suffer from headaches or neck pain after a head injury in the past year. Participants must have tried at least one treatment without success, such as migraine prevention meds, neuropathic pain meds, physical therapy, or cognitive-behavioral therapy. Those with significant psychological issues or unable to consent are excluded.

Inclusion Criteria

I have had headaches or neck pain after a head injury in the past year.
I am between 14 and 45 years old.
I've tried at least one treatment for my condition without significant improvement.

Exclusion Criteria

I (or my child) can't participate due to not giving consent or being unable to complete the questionnaire.
You have serious mental health issues, as decided by a study psychologist after reviewing a standard test.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either an occipital nerve block or a cervical medial branch block. If a >50% pain reduction is observed after four weeks, they may continue to receive blocks as needed, but not more than one every three months.

4 weeks
1 visit (in-person) for initial treatment, follow-up as needed

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of headache severity, frequency, and quality of life.

12 months
Weekly for 2 months, then bi-weekly for 10 months

Treatment Details

Interventions

  • Cervical Medial Branch Block (CMBB)
  • Occipital Nerve Block (ONB)
Trial Overview The study tests two procedures: Cervical Medial Branch Block (CMBB) and Occipital Nerve Block (ONB), both using lidocaine and dexamethasone to manage post-traumatic headaches. It's a randomized controlled trial comparing these invasive treatments' effectiveness against standard conservative care.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Occipital Nerve BlockExperimental Treatment1 Intervention
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 II: Cervical Medial Branch BlockExperimental Treatment1 Intervention
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials
801
Recruited
5,584,000+

Harvard University

Collaborator

Trials
237
Recruited
588,000+

Beth Israel Deaconess Medical Center

Collaborator

Trials
872
Recruited
12,930,000+
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