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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe University of Queensland

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • SPINEPASS Physical Therapy
  • Standard Physical Therapy

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators

The University of Queensland

Lead sponsor

Brooke Army Medical Center

Collaborator

United States Department of Defense

Collaborator