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Physical Therapy Targeting Autonomic and Dura Mater Function: SPINEPASS Randomized Clinical Trial Protocol
Julia Treleaven1, Matt Hammerle2, Alicia Swan3
1School of Health and Rehabilitation, University of Queensland, School of Health and Rehabilitation Sciences, St Lucia, QLD 4067, Australia.
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.
