Occipital Nerve Block (ONB) using lidocaine and dexamethosone for Post-Traumatic Headaches

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Beth Israel Deaconess Medical Center, Boston, MA
Post-Traumatic Headaches+2 More
Occipital Nerve Block (ONB) using lidocaine and dexamethosone - Drug
Eligibility
< 65
All Sexes
Eligible conditions
Select

Study Summary

A Prospective Controlled Treatment Trial for Post-Traumatic Headaches

See full description

Eligible Conditions

  • Post-Traumatic Headaches

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Post-Traumatic Headaches

Study Objectives

This trial is evaluating whether Occipital Nerve Block (ONB) using lidocaine and dexamethosone will improve 1 primary outcome and 7 secondary outcomes in patients with Post-Traumatic Headaches. Measurement will happen over the course of 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).

Month 12
Change in pain intensity scores using the numerical rating scale (NRS)
Functional Disability Scores
Headache Frequency assessed by Migraine Disability Assessment (MIDAS)
Headache Frequency assessed by the Pediatric Migraine Disability Assessment (PedMIDAS)
Headache severity assessed by Migraine Disability Assessment (MIDAS)
Headache severity assessed by the Pediatric Migraine Disability Assessment (PedMIDAS)
Quality of Life Assessment assessed by Quality of Life Assessment (QL)
Quality of Life Assessment assessed by the Pediatric QL (PedsQL)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Post-Traumatic Headaches

Trial Design

2 Treatment Groups

Cervical Medial Branch Block
1 of 2
Occipital Nerve Block
1 of 2
Experimental Treatment

This trial requires 63 total participants across 2 different treatment groups

This trial involves 2 different treatments. Occipital Nerve Block (ONB) Using Lidocaine And Dexamethosone is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Cervical Medial Branch Block
Drug
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.
Occipital Nerve Block
Drug
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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 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 has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 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.

Who is running the study

Principal Investigator
P. D. F.
Prof. Pradeep Dinakar,, FAAP, MD
Boston Children's Hospital

Closest Location

Beth Israel Deaconess Medical Center - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. You must have received 1 prior treatment for Post-Traumatic Headaches or one of the other 2 conditions listed above. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The person has tried at least one previous treatment that didn't offer any meaningful benefit. show original
Age 14 - 45 years
A person who has had a concussion or head injury within the past 12 months may experience post-traumatic headache or neck pain. show original

Patient Q&A Section

What are the signs of headache?

"The three most common headache symptoms are fatigue, sensitivity to light and pain upon palpation of the head. These head symptoms are associated with a wide range of conditions and can affect individuals of any age and gender. Hence, headache should be ruled out in any individual with symptoms consistent with those of an underlying condition of the head and neck." - Anonymous Online Contributor

Unverified Answer

What causes headache?

"Headache might be related directly or indirectly to multiple physiological, emotional, physical, psychiatric and neurological factors and it is likely to be much more complicated and complex than simply being the product of the interaction between those factors and the sensory nervous system." - Anonymous Online Contributor

Unverified Answer

How many people get headache a year in the United States?

"Each year in the United States, approximately one-third to one-fourth of adults, aged 18–45 years, get a headache. In this group, the greatest number of people reported having two or more headache symptoms. Moreover, headache is a chronic disorder, so this information could help in planning a proper treatment and improving outcomes." - Anonymous Online Contributor

Unverified Answer

What is headache?

"The prevalence of headaches is high, with at least 1 in 5 individuals reporting one in a given year. Both acute and chronic headaches are prevalent; chronic headache can be the leading cause of a decreased quality of life in migraine and tension-type headache, with approximately 1 in 3 individuals reporting headaches that are disabling enough to decrease quality of life." - Anonymous Online Contributor

Unverified Answer

Can headache be cured?

"Currently there seems to be little evidence to support the notion that headache, especially [migraine](https://www.withpower.com/clinical-tri[als](https://www.withpower.com/clinical-trials/als)/migraine), can be cured. Further, there is no evidence to indicate the effectiveness of such a treatment and the possibility that it is harmful is also considered high. The use of a non-drug analgesic/mild analgesic (e.g. paracetamol) or an NSAID (e.g. ibuprofen) rather than a analgesic, may help people with chronic, recurrent headaches but has not resulted in a cure. Evidence to support the use of cannabis for chronic headaches is limited to anecdotes. No clear evidence exists to support the use of analgesics such as gabapentin, for the management of chronic migraine." - Anonymous Online Contributor

Unverified Answer

What are common treatments for headache?

"The treatments commonly used for headache are conservative, as with other pain syndromes. In general, headache is rarely treated as an inpatient, instead it is usually treated as an outpatient. As noted above, medications are commonly used for treating headache, but there are no medicines that are effective for all head pain." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of headache?

"Many causes of headache have been described, including [neuro- vascular, vascular, inflammatory, infectious, central nervous system, and central nervous system tumors] (https://www.rachea.com/health-problems/headache/headaches-and-causes). The underlying cause is best known and can be found from case studies that are carefully conducted and monitored. Clinical trials are currently available for migraine and [Neuro- vascular and idiopathic headache] (https://www.clinicaltrials.gov/ct2/show/NCT02296331). All treatments used in clinical trials are based on the best available evidence to treat migraine and idiopathic headache." - Anonymous Online Contributor

Unverified Answer

What is the latest research for headache?

"There is much new information about headache, but there is a lot to learn about how to use it. Please see 'Sources & Future directions'. The 'Sources' Table gives an overview of what is known about headache and the 'Future directions' section gives an outline of future aims and developments. Clinicians who care for headache patients must have the latest available resources to accurately evaluate the condition and provide better patient management." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating headache?

"Since 2000 the treatment options of chronic daily headache syndromes have remained unchanged and no new discoveries concerning new drugs for CCHD have appeared over that time frame. The current treatments for CCHD have no evidence-based recommendations for selecting among the many nonpharmacologic and medical therapies." - Anonymous Online Contributor

Unverified Answer

Has occipital nerve block (onb) using lidocaine and dexamethosone proven to be more effective than a placebo?

"OCNB with lidocaine and dexamethosone was found to be more effective than a placebo in patients with refractory chronic headaches. Although it showed effectiveness in relieving all 4 symptoms, the most effective part could be the reduction of pain." - Anonymous Online Contributor

Unverified Answer

How serious can headache be?

"Untreated headaches can lead to disability to [people with migraine-related headaches can experience: an increased risk of suicide, more frequent headache attacks, and an increased chance to have migraines] (http://www.headache.org/how/migraines). However, untreated attacks [cause an increased risk of sudden severe headache attacks, and can also lead to more migraines in a short amount of time.] (http://www.headache.org/how/headaches). You can find the most recent headache clinical trials by using Power, which allows you to search trials tailored to your condition, location, and ideal treatment." - Anonymous Online Contributor

Unverified Answer

Does occipital nerve block (onb) using lidocaine and dexamethosone improve quality of life for those with headache?

"In a recent study, findings suggest that occipital nerve block, when performed in the clinic setting using lidocaine and dexamethasone, can provide significant pain relief and improvement in quality of life with a minimal incidence of side effects and minimal complications compared with conventional occipital nerve block." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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