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Corticosteroid

Nerve Blocks for Post-Traumatic Headache

Phase 3

Waitlist Available

Research Sponsored by Boston Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 14 - 45 years

Be younger than 65 years old

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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)

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Pivotal Trial

Summary

This trial is looking at the effect of two invasive procedures, occipital nerve block (ONB) and cervical medial branch block (CMBB), on post-traumatic headaches (PTH).

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects of CMBB and ONB may include soreness at the injection site, allergic reactions to medications used like lidocaine or dexamethasone, nerve damage risks, headache worsening temporarily after the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 14 and 45 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I (or my child) can't participate due to not giving consent or being unable to complete the questionnaire.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Functional Disability Scores

Headache Frequency assessed by Migraine Disability Assessment (MIDAS)

Headache Frequency assessed by the Pediatric Migraine Disability Assessment (PedMIDAS)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

0 / 2Eligibility criteria met