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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 120 participants or records.
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