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SPINEPASS for Persistent Headache After Concussion

This study is testing two different physical therapy approaches for persistent headaches that occur after a concussion. It's for people aged 18 to 65 who have had persistent post-traumatic headaches for at least four weeks and haven't seen improvement in the last three weeks. One approach is called SPINEPASS Physical Therapy, which involves daily exercises to improve spinal and dural (the tough membrane covering the brain and spinal cord) movement. The other is Standard Physical Therapy, which focuses on neck and upper back treatments. The goal is to see if SPINEPASS is better at reducing headache disability and helping you manage your headaches more effectively. The study plans to enroll 120 participants, but its current status is unclear.

Study design
This is a randomized controlled trial comparing two physical therapy approaches, SPINEPASS Physical Therapy and Standard Physical Therapy, with 120 planned participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 12 months after treatment completion to assess headache impact and confidence in self-managing headaches.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06882239

SPINEPASS: SPINE Self-management Techniques for Persistent Headache After Concussion: Physical Therapy Targeting Autonomic and Dura Mater Function.

Not Yet Recruiting
NAAges 18–65InterventionalTreatment
The University of Queensland
~120 participants
Updated 2025-03-18 on ClinicalTrials.gov
What's tested:SPINEPASS Physical TherapyStandard Physical Therapy

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Headache Impact Test (HIT-6)
Measured over Baseline to T1 (treatment completion -up to 12 weeks), T2 (3 months following T1), T3 (12 months following T1)
+1 more outcome measured

Conditions

Persistent Post-concussive Symptoms
Post Traumatic Headache

Explore related trials

Persistent Post-concussive SymptomsPosttraumatic headache

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Lucy C Dr Lucy Thomas, PhD · PRINCIPAL_INVESTIGATOR · The University of Queensland
  • Julia M Dr Julia Treleaven, PhD · PRINCIPAL_INVESTIGATOR · University of Queensalnd
  • Amy 0 Dr Amy Bowles, MD · STUDY_DIRECTOR · Brooke Army Medical Center

Who to contact

Lucy C Dr Lucy Thomas, PhD
[email protected]
+61 336 51644
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Headache Impact Test (HIT-6)Baseline to T1 (treatment completion -up to 12 weeks), T2 (3 months following T1), T3 (12 months following T1)

    The HIT-6 is a validated measure of disability associated with headache and has been shown to be useful in migraine. A higher score indicates greater disability. Scores between 50 and 55 represent some impact; scores between 56 and 59 represent substantial impact, and scores \> 60 indicate severe impact. A reduction in the score of six or more is considered a clinically meaningful change.

  • Confidence to self-manage headacheBaseline; T1 (treatment completion- up to 12 weeks); T2 (3 months post T1)

    An electronic diary will ask the patients to rate their perceived ability to self-manage (a) lower and b) eliminate their headache using the exercises or tools, (without abortive medication measures), each week using a % scale, where 100% indicates the patient can manage it perfectly and 0% indicates an inability to manage the headache. This score is based on measures of global perceived effect or rating scales but modified to be captured in a percentage score.