Clinical trial NCT06882239: SPINEPASS: SPINE Self-management Techniques for Persistent Headache After Concussion: Physical Therapy Targeting Autonomic and Dura Mater Function.
Official title: SPINEPASS: SPINE Self-management Techniques for Persistent Headache After Concussion: Physical Therapy Targeting Autonomic and Dura Mater Function
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Persistent Post-concussive Symptoms
Post Traumatic Headache
Keywords: Persistent post-concussion headache
autonomic
dura
physical therapy
concussion
military
Lead sponsor: The University of Queensland
Sponsor class: OTHER
Collaborators: name: Brooke Army Medical Center
name: United States Department of Defense
First posted: 2025-03-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective randomized controlled trial comparing two different physical therapy approaches to the treatment of posttraumatic headache with autonomic symptoms. AIM 1: To establish the efficacy of SPINEPASS against Standard Physical Therapy to reduce headache disability and impact amongst patients with persistent post-concussion headache. AIM 2: Demonstrate the superiority of SPINEPASS in the efficient self-management of headache. Demonstrate its appropriateness, acceptability, and feasibility and gain patient insights among patients with PPTH compared to standard PT.

Detailed description: 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:

1. To test SPINEPASS against standard PT in a randomized controlled trial, (RCT), to improve headache disability.
2. 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 \[themes from qualitative interview\].

Eligibility criteria: Inclusion Criteria:

* Persistent Post-traumatic headache (PPTH) duration =or \> 4 weeks.
* No self-reported improvement in headache pattern in the past 3 weeks. (Patients will be asked to determine whether the usual pattern of their headaches has changed for the better over the last 3 weeks.
* Compass-31 score \> 21 to select patients who have evidence of ANS dysfunction which SPINEPASS aims to address.
* Headache Impact Test (HIT6) =\>50 to capture headache-related disability of "some impact" or more.
* Headache worst intensity \>3/10 on a numerical rating scale (NRS), at least once per week.

Exclusion Criteria:

* Contraindications for spinal or graded general exercise.

  * Contraindications to spinal manual therapy at or below C5-6 level
* Cognitive impairment/ language barriers affecting ability to participate.
* Redeployment/relocation or retirement planned within the next 6 months to reduce the chances of dropouts to treatment and follow-up.
* Rating self-confidence to manage (eliminate and or lower) headaches without abortive medication at baseline of 30% or greater.
* Inability to attend up to 12 in-person treatment sessions for 4 months.
* Unwilling to limit commencement of other management for PPTH during the trial period.
* Botox for headache management within the last 8 weeks or during the trial.

Primary outcomes:
measure: Headache Impact Test (HIT-6)
timeFrame: Baseline to T1 (treatment completion -up to 12 weeks), T2 (3 months following T1), T3 (12 months following T1)
measure: Confidence to self-manage headache
timeFrame: Baseline; T1 (treatment completion- up to 12 weeks); T2 (3 months post T1)
Secondary outcomes:
measure: Composite Autonomic Symptom Score (COMPASS-31)
timeFrame: Baseline to T1 (treatment completion -up to 12 weeks), T2 (3 months following T1), T3 (12 months following T1)
measure: Neurobehavioral Symptom Inventory (NSI).
timeFrame: Baseline to T1 (treatment completion -up to 12 weeks), T2 (3 months following T1), T3 (12 months following T1)
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Brook Army Medical Center
state: Texas
Study officials:
affiliation: The University of Queensland
name: Lucy C Dr Lucy Thomas, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Queensalnd
name: Julia M Dr Julia Treleaven, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brooke Army Medical Center
name: Amy 0 Dr Amy Bowles, MD
role: STUDY_DIRECTOR
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