Physical Therapy Targeting Autonomic and Dura Mater Function: SPINEPASS Randomized Clinical Trial Protocol

Abstract

Importance Persistent post-traumatic headache (PPTH) or concussion is a significant United States military problem, and pharmacological treatment is often ineffective. Headache is commonly migraine-like with associated autonomic nervous system (ANS) symptoms. Injury to the brain and neck likely co-occur during concussion, and recent research suggests resulting upper cervical hypermobility may trigger an ANS response and PPTH. A promising rehabilitation program (SPINE self-management techniques for Persistent headache After concuSSion [SPINEPASS]) has been developed, directed toward dysfunction of the upper cervical region, myodural bridges, and changes throughout the entire spine affecting the dura. Objective The aim of this trial is to explore (1) the efficacy of SPINEPASS physical therapy compared to standard physical therapy for PPTH and (2) patient experiences, and acceptability and feasibility of the program. Design The study will be a randomized controlled trial. Setting The trial will be conducted at a military hospital outpatient setting at the Brooke Army Medical Center, Brain Injury Rehabilitation Service, San Antonio, Texas. Participants Participants will be active-duty military personnel (n=120) with PPTH and ANS symptoms >1 month. Interventions Patients will receive up to 12, 1 hour, 1 on 1 physical therapist sessions of either SPINEPASS or standard physical therapy and a complete home exercise program. Main Outcomes and Measurements The primary outcome measures are Aim 1 (headache disability) and Aim 2 (self-confidence to manage headache, acceptability, and feasibility immediately postintervention, and patient perspectives 3 months postintervention). Aim 1 secondary outcome measures: ANS symptoms, headache diary parameters, pain self-efficacy, quality of life, neck pain and disability, and pupillometry. Three- and 12-month follow-ups will also be performed. Limitations Potential limitations include recruitment feasibility and lost to follow-up. Conclusions The focus of the research will examine new non-pharmaceutical treatment of PPTH in military personnel. Relevance The study has potential to reduce ongoing pain, disability, and burden of PPTH and reduce dependence on pharmaceutical management.