SPINEPASS Physical Therapy for Post-Concussion Headache
(SPINEPASS Trial)

Recruiting in Palo Alto (17 mi)

Overseen byLucy C Dr Lucy Thomas, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: The University of Queensland

No Placebo Group

Trial Summary

What is the purpose of 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

This trial is for individuals with persistent headaches following a concussion, lasting at least 4 weeks, who experience autonomic symptoms and have not seen improvement recently. Participants should have moderate to severe headache impact but cannot start other treatments during the study or plan to move away within six months.

Inclusion Criteria

I have had headaches for 4 weeks or more after an injury.

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

+2 more

Exclusion Criteria

Redeployment/relocation or retirement planned within the next 6 months

Contraindications for spinal or graded general exercise

Cognitive impairment/language barriers affecting ability to participate

+5 more

Participant Groups

The SPINEPASS clinical trial compares two physical therapy methods: SPINEPASS Physical Therapy aimed at self-managing headaches by targeting autonomic and dura mater function versus Standard Physical Therapy, focusing on reducing headache disability in post-concussion patients.

2Treatment groups

Experimental Treatment

Active Control

Group I: SPINEPASSExperimental Treatment1 Intervention

The treatment utilizes anatomy and biomechanics education to inform manual therapy and specific exercises to target areas, such as occipito-atlantal and/or atlanto-axial segmental guarded hypermobility. It also addresses general spinal (thoracic, sacroiliac, rib) and adjacent dysfunction (e.g., temporomandibular joint and lower limb) as required. The treatment targets will be individualized based on initial and ongoing evaluation and will include knowledge, skills, and volitional ingredients. SPINEPASS consists of a core set of three daily exercises integrated into daily activities to improve/restore overall spinal and dural mobility and or stability. It also provides training in the use of specific tools to be used as needed to address symptoms as they occur. Treatment can also include spinal manual therapy and other exercises to enhance the tools, but the emphasis is on self-management.

Group II: Standard Physical TherapyActive Control1 Intervention

Participants will be evaluated by the treating physical therapist to address impairments or dysfunction in cervical musculoskeletal structures, the vestibular and or oculomotor system, and the autonomic nervous system (ANS). They will then be prescribed suitable therapeutic exercises for any cervical, vestibular or oculomotor impairments, and they will be provided with advice and education for graded aerobic exercise and or relaxation and breathing exercises (based on patient preference), consistent with the current recommendations for ANS management post mTBI. The cervical therapy for standard Physical Therapy will be based on impairments found but could include cervical and or thoracic manual therapy, exercises to improve segmental range of motion, exercises for cervical and axioscapular neuromotor retraining, and specific cervical related sensorimotor control exercises such as proprioceptive retraining. A home program of exercises tailored for the individual will be provided.