Status:
NOT_YET_RECRUITING
SPINEPASS: SPINE Self-management Techniques for Persistent Headache After Concussion: Physical Therapy Targeting Autonomic and Dura Mater Function.
Lead Sponsor:
The University of Queensland
Collaborating Sponsors:
Brooke Army Medical Center
United States Department of Defense
Conditions:
Persistent Post-concussive Symptoms
Post Traumatic Headache
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 effica...
Detailed Description
Persistent post traumatic headache (PPTH) is a significant problem for the US military affecting up to 33% of service members with a history of mild traumatic brain injury (mTBI) and treatment is usua...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06882239
Start Date
May 1 2025
End Date
September 30 2028
Last Update
March 18 2025
Active Locations (1)
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1
Brook Army Medical Center
San Antonio, Texas, United States, 78234