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Corticosteroid

Nerve Blocks for Post-Traumatic Headache

Phase 3
Recruiting
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
History of post-traumatic headache or neck pain following a concussion or head injury within the last 12 months
Age 14 - 45 years
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

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

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)
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in pain intensity scores using the numerical rating scale (NRS)
Secondary outcome measures
Functional Disability Scores
Headache Frequency assessed by Migraine Disability Assessment (MIDAS)
Headache Frequency assessed by the Pediatric Migraine Disability Assessment (PedMIDAS)
+4 more

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.

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor
758 Previous Clinical Trials
5,579,247 Total Patients Enrolled
2 Trials studying Headache
79 Patients Enrolled for Headache
Beth Israel Deaconess Medical CenterOTHER
836 Previous Clinical Trials
13,010,262 Total Patients Enrolled
2 Trials studying Headache
106 Patients Enrolled for Headache
Harvard UniversityOTHER
229 Previous Clinical Trials
474,525 Total Patients Enrolled
2 Trials studying Headache
525 Patients Enrolled for Headache

Media Library

Cervical Medial Branch Block (CMBB) (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT03007420 — Phase 3
Headache Research Study Groups: Cervical Medial Branch Block, Occipital Nerve Block
Headache Clinical Trial 2023: Cervical Medial Branch Block (CMBB) Highlights & Side Effects. Trial Name: NCT03007420 — Phase 3
Cervical Medial Branch Block (CMBB) (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03007420 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Will elderly citizens be able to partake in this research?

"The age range for this clinical trial is 14 to 45. If you are either younger or older, there are still many options available as there are 31 studies for patients under 18 and 207 for those over 65."

Answered by AI

Are there any other published reports of similar medical trials involving lidocaine and dexamethasone for ONB?

"There are a total of 135 clinical studies underway that are investigating the use of lidocaine and dexamethasone in Occipital Nerve Block (ONB). Out of these, 34 are in Phase 3. The majority of research locations for Occipital Nerve Block (ONB) using lidocaine and dexamethosone are in Calgary, Alberta; however, there are 1,083 total sites running these studies."

Answered by AI

Is the ONB procedure that uses lidocaine and dexamethasone currently federally regulated?

"The safety of Occipital Nerve Block (ONB) using lidocaine and dexamethosone has been rigorously tested in Phase 3 clinical trials, so our team rates its safety as a 3."

Answered by AI

How does ONB using lidocaine and dexamethosone help patients?

"Although most commonly used to treat cervical syndrome, lidocaine and dexamethasone-based ONB can also help patients with conditions like minor burns, transplantation, and osteoporosis."

Answered by AI

How many enrollees are in this clinical trial?

"Yes, according to the website clinicaltrials.gov, this study is still looking for participants. This particular trial was first posted on 2018-01-02, and the listing was updated on 2022-09-21. They are hoping to enroll 63 individuals at 2 different locations."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
How old are they?
18 - 65
What site did they apply to?
Beth Israel Deaconess Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
~9 spots leftby Mar 2025