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
Sponsors and collaborators
The University of Queensland
Lead sponsor
Brooke Army Medical Center
Collaborator
United States Department of Defense
Collaborator