Persistent post traumatic headache (PPTH) is a significant problem for the US military
affecting up to 33% of service members with a history of mild traumatic brain injury
(mTBI) and treatment is usually ineffective. The persistent and chronic nature of PPTH
leads to significant disability, burden and reduced readiness. It is commonly
migraine-like and associated with visual complaints, and transient neurological
abnormalities that can be classified as autonomic nervous system (ANS) in nature. Due to
the forces involved during concussion, injury to the brain and neck likely co-occur.
Recent research suggests that upper cervical hypermobility may trigger an ANS response
and be related to these headaches, due to close anatomical connections to the ANS and
dura. Specifically, the dura has unique upper cervical myodural connections to help
protect the spinal cord during head movements, with attachments throughout the entire
spine. It is innervated by the ANS, is pain sensitive and can cause headache.
The investigators developed a rehabilitation approach to effectively address headache and
ANS symptoms in patients. The treatment is hypothesized to influence dura mater and ANS
function by addressing the consequences of upper cervical hypermobility. The treatment is
a pragmatic biomechanical approach individualized to patients' specific impairments. The
approach to this treatment is named SPINE self-management techniques for Persistent
headache After concuSSion (SPINEPASS), and it pairs specific personal physical therapy
(PT) targets with treatment ingredients.
In this study the investigators plan to conduct a randomized controlled trial (RCT), with
a community-based participatory research approach, to explore the efficacy of the
SPINEPASS approach on headache disability and self-confidence to manage headache without
abortive medication, compared to standard physical therapy (PT) for persistent symptoms
post-mTBI. Standard PT will specifically address the neck and the vestibular and
oculomotor systems as well as prescribing graded exercise and or relaxation training for
management of ANS dysfunction. It does not address the dura mater and while it will aim
to stabilize the upper cervical spine, it does not consider the precise restoration of
balance of the upper cervical muscles or consider the role of the dura mater to protect
and maintain patency of the spinal cord and brain. The investigators will also explore
patient experiences and acceptability and feasibility of the program. The hypothesis is
that overall, patients will have unique insights and will rate SPINEPASS more
appropriate, acceptable and feasible.
Concurrently, the study will include a qualitative arm interviewing participants
post-treatment to incorporate an understanding of participants' perspectives on the
program to enable effective and sustainable translation of the program into clinical
practice. It will consider whether individual confidence for self-management of PPTH is
improved in the short and intermediate term and consider participants' perspectives on
feasibility, acceptability, and appropriateness of the program as well as factors
contributing to the success or failure of these treatment approaches.
Objectives/Specific Aims/Hypotheses:
The purpose of this study is to determine the effect of SPINEPASS, a pragmatic novel PT
management program directed towards the spine to target ANS and dura function, in
military personnel to reduce headache disability in the short and intermediate term.
The overall objectives of the study are:
To test SPINEPASS against standard PT in a randomized controlled trial, (RCT), to
improve headache disability.
To understand participants' views on the program compared to standard PT and
understand factors contributing to success or failure of these treatment approaches.
This will be achieved by evaluating patient self-confidence to manage headache,
participants' perceptions of the appropriateness, acceptability, and feasibility of
SPINEPASS compared to standard PT, and interviewing the participants.
Specific aims and study design:
To evaluate up to 12 sessions of SPINEPASS versus standard PT within a 4- month period
and understand participants' views on the program.
Aim 1: Establish the efficacy of the novel, patient centered SPINEPASS against standard
PT to reduce headache disability, severity, and impact among patients with PPTH following
mTBI using an RCT with a parallel design.
Hypothesis 1.1a: Individuals with PPTH will have significant improvement in headache
disability (HIT-6) (primary outcome) following SPINEPASS compared to those who have
standard PT immediately following treatment [Primary outcome].
Hypothesis 1.1b: Participants who undergo SPINEPASS will have significantly greater
improvements in headache severity (i.e., intensity range, frequency, duration, medication
intake), related symptom severity (i.e., autonomic symptom severity), and functional
outcomes (i.e., self-efficacy, quality of life, health locus of control) compared to
standard PT [secondary outcomes].
Hypothesis 1.2: Participants who complete SPINEPASS will continue to report significantly
less headache disability than those who complete standard PT at the 3 and 12-month
follow-up [T2 and T3].
Aim 2: Demonstrate the superiority of SPINEPASS in the efficient self-management of
headache and, in its appropriateness, acceptability, and feasibility and patient insights
among patients with PPTH compared to standard PT.
Hypothesis 2.1: Individuals with PPTH will have significant improvement in
self-confidence to manage headache (a) lower intensity and b) eliminate entirely) without
abortive medication at T1, T2, T3 following SPINEPASS compared to those who have standard
PT.
Hypothesis 2.2: Patients who undergo SPINEPASS will require fewer treatment sessions to
achieve 50% confidence to manage (lower and or eliminate) headaches without abortive
medication and fewer treatments overall compared to the standard PT group.
Hypothesis 2.3: Participants in SPINEPASS will have better adherence to the exercise
program compared to Standard PT.
Hypothesis 2.4: Participants will find the SPINEPASS program appropriate, acceptable, and
feasible on quantitative measures (Appropriateness of Intervention, Acceptability of
Intervention, Feasibility of Intervention measures).
Hypothesis 2.5: Participants will have unique insights into factors contributing to the
success or failure of the individual treatment approaches and home exercises compatible
with military lifestyle [themes from qualitative interview].