Clinical trial
A Prospective Controlled Treatment Trial for Post-Traumatic Headaches
Name
IRB-P00025021
Description
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.
Trial arms
Trial start
2018-01-02
Estimated PCD
2024-12-01
Trial end
2025-12-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Occipital 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.
Arms:
Occipital Nerve Block
Cervical 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.
Arms:
Cervical Medial Branch Block
Size
63
Primary endpoint
Change in pain intensity scores using the numerical rating scale (NRS)
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)
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 63, 'type': 'ESTIMATED'}}
Updated at
2024-06-06
1 organization
2 products
1 indication
Organization
Boston Children's HospitalProduct
Occipital Nerve BlockIndication
Post-Traumatic Headaches