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.
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.
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.
Parallel
SPINEPASS Physical Therapy
Other interventionSPINEPASS 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.
Standard Physical Therapy
Other interventionThe 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.
Headache Impact Test (HIT-6)
The HIT-6 is a validated measure of disability associated with headache and has been shown to be useful in migraine. A higher score indicates greater disability. Scores between 50 and 55 represent some impact; scores between 56 and 59 represent substantial impact, and scores \> 60 indicate severe impact. A reduction in the score of six or more is considered a clinically meaningful change.
Confidence to self-manage headache
An electronic diary will ask the patients to rate their perceived ability to self-manage (a) lower and b) eliminate their headache using the exercises or tools, (without abortive medication measures), each week using a % scale, where 100% indicates the patient can manage it perfectly and 0% indicates an inability to manage the headache. This score is based on measures of global perceived effect or rating scales but modified to be captured in a percentage score.
Composite Autonomic Symptom Score (COMPASS-31)
COMPASS-31) is a validated measure and quantifies 6 domains relating to ANS function: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder and pupillomotor. The 6 subscales are weighted and sum to a total COMPASS-31 score of 0 to 100 with higher scores indicating greater disability. Medians and ranges for healthy volunteers are 10 ± 8 (mean age 46.6 years). Scores of \>21 indicate elevated autonomic symptoms. Usually the score is based on symptoms in the year preceding assessment. To allow comparison of symptoms during treatment we have investigated using a modified version of the questionnaire for symptoms over the last month and compared it to the original questionnaire (last year). The COMPASS-31 (last month) was comparable (last year), and the COMPASS-31 (last month) was responsive with a large effect size (1.3) post-intervention, suggesting that this is a suitable outcome measure for use in these participants.
Neurobehavioral Symptom Inventory (NSI).
The NSI is a 22-item inventory/88 that assesses symptoms associated with TBI with established reliability and validity, although these symptoms are not specific to concussion. Responses range from 0 (none) to 4 (very severe) and address how much each symptom has disturbed the patient in the last two weeks.43, 44 This documents patients' subjective complaints across ocular, vestibular/auditory, cognitive, and affective domains. Both total and domain scores will be used to document the characteristics of the cohort as this measure is routinely used in the US military following TBI.
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The University of Queensland
Lead sponsor
Brooke Army Medical Center
Collaborator
United States Department of Defense
Collaborator
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