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

Starting soon · Not applicable

Conditions studied: Persistent Post-concussive Symptoms, Post Traumatic Headache

In brief

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.

Key facts

Study ID

NCT06882239

Run by

The University of Queensland

People needed

120

Starts

2025-05-01

Expected to finish

2028-09-30

Last updated by the study team

2025-03-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Brook Army Medical Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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