A Prospective Controlled Treatment Trial for Post-Traumatic Headaches

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03007420

Enrollment

Registered

2017-01-02

Start date

2018-01-02

Completion date

2024-06-14

Last updated

2025-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Traumatic Headaches

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.

Interventions

DRUGOccipital 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.

DRUGCervical 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

14 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Pain Score	One week, 1 month, 2 months, 3 months, 6months, 9 months, 12 months post-procedure	Pain intensity was rated using the Numerical Rating Scale (NRS) of 0 to 10, with 0 indicating 'no pain' and 10 indicating the 'worst pain imaginable'.

Secondary

Measure	Time frame	Description
Pediatric Migraine Disability Assessment (PedMIDAS)	Baseline, 3 months, 6 months, 9 months, 12 months	The Pediatric Migraine Disability Assessment (PedsMIDAS) is a self-administered standardized questionnaire to quantify headache related disability. The PedsMIDAS score ranges from 0 to 240. The higher the score on the PedsMIDAS questionnaire, the greater the disability caused by headaches.
Headache Severity Assessed by Migraine Disability Assessment (MIDAS)	Baseline, 3 months, 6 months, 9 months, 12 months	Self-administered questionnaire to quantify headache-severity using the following question: On a scale of 0 - 10, on average how painful were these headaches? (where 0=no pain at all, and 10=pain as bad as it can be)
Headache Severity Assessed by the Pediatric Migraine Disability Assessment (PedMIDAS)	Baseline, 3 months, 6 months, 9 months, 12 months	Self-administered questionnaire to quantify headache-related disability
Migraine Disability Assessed Using the Migraine Disability Assessment (MIDAS)	Baseline, 3 months, 6 months, 9 months, 12 months	The Migraine Disability Assessment (MIDAS) is a self-administered standardized questionnaire to quantify headache-related disability. The MIDAS score ranges from 0 to 270. The higher the score on the MIDAS questionnaire, the greater the disability caused by headaches.
Pain Disability Index (PDI)	Baseline, 3 months, 6 months, 9 months, 12 months	The Pain Disability Index (PDI) was used to assess functional disability in adults. The PDI is scored by summing the ratings of seven different life domains, each scored on a scale of 0 to 10, with higher scores indicating greater pain-related disability. The total score can range from 0 to 70. A higher score reflects a greater impact of pain on daily activities.
World Health Organization Quality of Life - Brief Assessment (WHOQOL-BREF)	Baseline, 2 months, 3 months, 6 months, 9 months, 12 months	The WHOQOL-BREF produces four domain scores (Physical health, Psychological, Social Relationships, and Environment) and two overall items (overall quality of life and general health). The scores range from 4-20 with higher scores indicating a better quality of life.
Pediatric Quality of Life Assessment (PedsQL)	Baseline, 2 months, 3 months, 6 months, 9 months, 12 months post procedure	The Pediatric Quality of Life Assessment (PedsQL) is a standardized questionnaire that assesses a pediatric patient's perceptions of health-related quality of life (HRQOL) with chronic health conditions using 4 domains (Physical, Emotional, Social, School Functioning). PedsQL scores range from 0-100 where higher scores indicate better health-related quality of life.
Functional Disability Inventory Scores (FDI)	Baseline, 3 months, 6 months, 9 months, 12 months	The Functional Disability Inventory (FDI) was used to assess functional disability. The FDI is scored by summing the ratings for each of its 15 items, with scores ranging from 0 to 60. Higher scores indicate greater perceived functional disability.

Countries

United States

Participant flow

Pre-assignment details

Patients were recruited from Boston Children's Hospital and Beth Israel Deaconess Medical Center. Eligibility Criteria included: * Age 14 - 45 years. * History of post-traumatic headache or neck pain following a concussion or head injury within the last 2 years. * Self-reported lack of meaningful benefit with at least one previous treatment trial.

Participants by arm

Arm	Count
Occipital Nerve Block After enrollment in the study, patients were randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. If patients exhibited a \> or = 50% pain reduction on receiving the block evaluated after four weeks, they had an option to continue receiving blocks as needed, but not more than one every three months. If patients exhibited \< 50% pain reduction, they were treated as per the clinician's judgment with the possibility of a cross over to the other treatment option.	8
Cervical Medial Branch Block After enrollment in the study, patients were randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. If patients exhibited a \> or = 50% pain reduction on receiving the block evaluated after four weeks, they had an option to continue receiving blocks as needed, but not more than one every three months. If patients exhibited \< 50% pain reduction, they were treated as per the clinician's judgment with the possibility of a cross over to the other treatment option.	8
Total	16

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Physician Decision	0	1
Overall Study	Withdrawal by Subject	0	2

Baseline characteristics

Characteristic	Total	Occipital Nerve Block	Cervical Medial Branch Block
Age, Continuous	22 years STANDARD_DEVIATION 6	23 years STANDARD_DEVIATION 6	21 years STANDARD_DEVIATION 7
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants	0 Participants	2 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants	7 Participants	5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants	1 Participants	1 Participants
Pain Score at Baseline	4.6 units on a scale	3.8 units on a scale	4.9 units on a scale
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) White	14 Participants	7 Participants	7 Participants
Sex: Female, Male Female	12 Participants	5 Participants	7 Participants
Sex: Female, Male Male	4 Participants	3 Participants	1 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 8	0 / 8	0 / 3	0 / 2
other Total, other adverse events	8 / 8	8 / 8	3 / 3	2 / 2
serious Total, serious adverse events	0 / 8	0 / 8	0 / 3	0 / 2

Outcome results

Primary

Pain Score

Pain intensity was rated using the Numerical Rating Scale (NRS) of 0 to 10, with 0 indicating 'no pain' and 10 indicating the 'worst pain imaginable'.

Time frame: One week, 1 month, 2 months, 3 months, 6months, 9 months, 12 months post-procedure

Population: 16 patients provided baseline pain score data that has been presented in the Baseline Demographics section. Post-procedure pain scores have been reported below.

Arm	Measure	Group	Value (MEDIAN)
Occipital Nerve Block	Pain Score	Numerical Rating Scale at 1 month post procedure time point	1 units on a scale
Occipital Nerve Block	Pain Score	Numerical Rating Scale at 2 months post procedure time point	2.3 units on a scale
Occipital Nerve Block	Pain Score	Numerical Rating Scale at 3 months post procedure time	2.1 units on a scale
Occipital Nerve Block	Pain Score	Numerical Rating Scale at 6 months post procedure time	1.8 units on a scale
Occipital Nerve Block	Pain Score	Numerical Rating Scale at 9 months post procedure time	0 units on a scale
Occipital Nerve Block	Pain Score	Numerical Rating Scale at 12 months post procedure time	0.5 units on a scale
Occipital Nerve Block	Pain Score	Numerical Rating Scale at 1 week post procedure timepoint	2.9 units on a scale
Cervical Medial Branch Block	Pain Score	Numerical Rating Scale at 1 month post procedure time point	1.6 units on a scale
Cervical Medial Branch Block	Pain Score	Numerical Rating Scale at 9 months post procedure time	3.6 units on a scale
Cervical Medial Branch Block	Pain Score	Numerical Rating Scale at 2 months post procedure time point	5.2 units on a scale
Cervical Medial Branch Block	Pain Score	Numerical Rating Scale at 1 week post procedure timepoint	3.7 units on a scale
Cervical Medial Branch Block	Pain Score	Numerical Rating Scale at 3 months post procedure time	1.7 units on a scale
Cervical Medial Branch Block	Pain Score	Numerical Rating Scale at 12 months post procedure time	3.4 units on a scale
Cervical Medial Branch Block	Pain Score	Numerical Rating Scale at 6 months post procedure time	0.8 units on a scale

Secondary

Functional Disability Inventory Scores (FDI)

The Functional Disability Inventory (FDI) was used to assess functional disability. The FDI is scored by summing the ratings for each of its 15 items, with scores ranging from 0 to 60. Higher scores indicate greater perceived functional disability.