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Search / Trial NCT06882239

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

Launched by THE UNIVERSITY OF QUEENSLAND · Mar 11, 2025

Trial Information

Current as of April 29, 2025

Not yet recruiting

Keywords

Persistent Post Concussion Headache Autonomic Dura Physical Therapy Concussion Military

ClinConnect Summary

The SPINEPASS clinical trial is studying two different physical therapy methods to help people who have persistent headaches after a concussion. These headaches, known as post-traumatic headaches, can last for more than four weeks and may come with other symptoms. The trial aims to see if the SPINEPASS approach is better than standard physical therapy in reducing headache pain and helping patients learn to manage their headaches on their own.

To participate in this trial, you need to have had headaches for at least four weeks without any signs of improvement recently. You should also experience a certain level of headache-related disability and have intense headaches at least once a week. If you're interested, you will attend up to 12 in-person sessions over four months, where you will receive treatment and support. Please note that certain conditions, like cognitive impairment or recent use of Botox for headaches, may prevent you from joining the study. This trial is not yet recruiting participants, but it could be an important step toward better treatment options for those struggling with post-concussive headaches.

Gender

ALL

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.

About The University Of Queensland

The University of Queensland (UQ) is a leading research institution located in Australia, renowned for its commitment to advancing health and medical knowledge through innovative clinical trials. With a strong emphasis on collaboration between academia, industry, and healthcare communities, UQ leverages its extensive resources and expertise to conduct high-quality research aimed at improving patient outcomes. The university's multidisciplinary approach facilitates the exploration of diverse therapeutic areas, ensuring rigorous scientific methodologies and adherence to ethical standards. UQ's dedication to fostering a culture of discovery positions it at the forefront of clinical research, contributing significantly to the global body of medical knowledge.

Locations

San Antonio, Texas, United States

Patients applied

0 patients applied

Trial Officials

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

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported