Clinical Trial: A Prospective Controlled Treatment Trial for Post-Traumatic Headaches
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: A Prospective Controlled Treatment Trial for 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 young adults (14-35 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 Summary:
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
Sponsor: Boston Children’s Hospital
Current Primary Outcome: Change in pain intensity scores using the numerical rating scale (NRS) [ Time Frame: 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) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Headache Frequency assessed by Migraine Disability Assessment (MIDAS) [ Time Frame: 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) ]Self-administered questionnaire to quantify headache-related disability
- Headache Frequency assessed by the Pediatric Migraine Disability Assessment (PedMIDAS) [ Time Frame: 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) ]Self-administered questionnaire to quantify headache-related disability
- Headache severity assessed by Migraine Disability Assessment (MIDAS) [ Time Frame: 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) ]Self-administered questionnaire to quantify headache-related disability
- Headache severity assessed by the Pediatric Migraine Disability Assessment (PedMIDAS) [ Time Frame: 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) ]Self-administered questionnaire to quantify headache-related disability
- Functional Disability Scores [ Time Frame: 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) ]Assessed using the Functional Disability Inventory (FDI)
- Quality of Life Assessment assessed by Quality of Life Assessment (QL) [ Time Frame: 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) ]Standardized questionnaire that assess adult patients perceptions of health-related quality of life (HRQOL) with chronic health conditions.
- Quality of Life Assessment assessed by the Pediatric QL (PedsQL) [ Time Frame: 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) ]Standardized questionnaire that assess a pediatric patients/parent's perceptions of health-related quality of life (HRQOL) with chronic health conditions.
Original Secondary Outcome: Same as current
Information By: Boston Children’s Hospital
Dates:
Date Received: December 22, 2016
Date Started: March 2017
Date Completion: December 2018
Last Updated: February 8, 2017
Last Verified: February 2017
