SPINEPASS: SPINE Self-management Techniques for Persistent Headache After Concussion: Physical Th… (NCT06882239) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
SPINEPASS: SPINE Self-management Techniques for Persistent Headache After Concussion: Physical Therapy Targeting Autonomic and Dura Mater Function.
United States120 participantsStarted 2025-05-01
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)
2
Confidence to self-manage headache
Timeframe: Baseline; T1 (treatment completion- up to 12 weeks); T2 (3 months post T1)