An interventional study of SPINEPASS Physical Therapy and Standard Physical Therapy in Persistent Post-concussive Symptoms and Post Traumatic Headache, sponsored by The University of Queensland. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-03-18.
Sponsored by The University of Queensland · Not applicable, Interventional, and Treatment
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) 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 usually ineffective. The persistent and chronic nature of PPTH leads to significant disability, burden and reduced readiness. It is commonly migraine-like and associated with visual complaints, and transient neurological abnormalities that can be classified as autonomic nervous system (ANS) in nature. Due to the forces involved during concussion, injury to the brain and neck likely co-occur. Recent research suggests that upper cervical hypermobility may trigger an ANS response and be related to these headaches, due to close anatomical connections to the ANS and dura. Specifically, the dura has unique upper cervical myodural connections to help protect the spinal cord during head movements, with attachments throughout the entire spine. It is innervated by the ANS, is pain sensitive and can cause headache.
The investigators developed a rehabilitation approach to effectively address headache and ANS symptoms in patients. The treatment is hypothesized to influence dura mater and ANS function by addressing the consequences of upper cervical hypermobility. The treatment is a pragmatic biomechanical approach individualized to patients' specific impairments. The approach to this treatment is named SPINE self-management techniques for Persistent headache After concuSSion (SPINEPASS), and it pairs specific personal physical therapy (PT) targets with treatment ingredients.
In this study the investigators plan to conduct a randomized controlled trial (RCT), with a community-based participatory research approach, to explore the efficacy of the SPINEPASS approach on headache disability and self-confidence to manage headache without abortive medication, compared to standard physical therapy (PT) for persistent symptoms post-mTBI. Standard PT will specifically address the neck and the vestibular and oculomotor systems as well as prescribing graded exercise and or relaxation training for management of ANS dysfunction. It does not address the dura mater and while it will aim to stabilize the upper cervical spine, it does not consider the precise restoration of balance of the upper cervical muscles or consider the role of the dura mater to protect and maintain patency of the spinal cord and brain. The investigators will also explore patient experiences and acceptability and feasibility of the program. The hypothesis is that overall, patients will have unique insights and will rate SPINEPASS more appropriate, acceptable and feasible.
Concurrently, the study will include a qualitative arm interviewing participants post-treatment to incorporate an understanding of participants' perspectives on the program to enable effective and sustainable translation of the program into clinical practice. It will consider whether individual confidence for self-management of PPTH is improved in the short and intermediate term and consider participants' perspectives on feasibility, acceptability, and appropriateness of the program as well as factors contributing to the success or failure of these treatment approaches.
Objectives/Specific Aims/Hypotheses:
The purpose of this study is to determine the effect of SPINEPASS, a pragmatic novel PT management program directed towards the spine to target ANS and dura function, in military personnel to reduce headache disability in the short and intermediate term.
The overall objectives of the study are:
Specific aims and study design:
To evaluate up to 12 sessions of SPINEPASS versus standard PT within a 4- month period and understand participants' views on the program.
Aim 1: Establish the efficacy of the novel, patient centered SPINEPASS against standard PT to reduce headache disability, severity, and impact among patients with PPTH following mTBI using an RCT with a parallel design.
Hypothesis 1.1a: Individuals with PPTH will have significant improvement in headache disability (HIT-6) (primary outcome) following SPINEPASS compared to those who have standard PT immediately following treatment [Primary outcome].
Hypothesis 1.1b: Participants who undergo SPINEPASS will have significantly greater improvements in headache severity (i.e., intensity range, frequency, duration, medication intake), related symptom severity (i.e., autonomic symptom severity), and functional outcomes (i.e., self-efficacy, quality of life, health locus of control) compared to standard PT [secondary outcomes].
Hypothesis 1.2: Participants who complete SPINEPASS will continue to report significantly less headache disability than those who complete standard PT at the 3 and 12-month follow-up [T2 and T3].
Aim 2: Demonstrate the superiority of SPINEPASS in the efficient self-management of headache and, in its appropriateness, acceptability, and feasibility and patient insights among patients with PPTH compared to standard PT.
Hypothesis 2.1: Individuals with PPTH will have significant improvement in self-confidence to manage headache (a) lower intensity and b) eliminate entirely) without abortive medication at T1, T2, T3 following SPINEPASS compared to those who have standard PT.
Hypothesis 2.2: Patients who undergo SPINEPASS will require fewer treatment sessions to achieve 50% confidence to manage (lower and or eliminate) headaches without abortive medication and fewer treatments overall compared to the standard PT group.
Hypothesis 2.3: Participants in SPINEPASS will have better adherence to the exercise program compared to Standard PT.
Hypothesis 2.4: Participants will find the SPINEPASS program appropriate, acceptable, and feasible on quantitative measures (Appropriateness of Intervention, Acceptability of Intervention, Feasibility of Intervention measures).
Hypothesis 2.5: Participants will have unique insights into factors contributing to the success or failure of the individual treatment approaches and home exercises compatible with military lifestyle [themes from qualitative interview].
192 studies on the registry are indexed under Post-Traumatic Headache; 54 are open to participants now.
This study's planned enrollment of 120 is above the median of 44 across 169 interventional studies indexed under Post-Traumatic Headache.
Browse Post-Traumatic Headache studies →The University of Queensland is the lead sponsor of 91 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
for spinal or graded general exercise.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: SPINEPASS Physical Therapy
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.
Other: Standard Physical Therapy
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.
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.
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.
Time frame: Baseline to T1 (treatment completion -up to 12 weeks), T2 (3 months following T1), T3 (12 months following T1)
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.
Time frame: Baseline; T1 (treatment completion- up to 12 weeks); T2 (3 months post T1)
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.
Time frame: Baseline to T1 (treatment completion -up to 12 weeks), T2 (3 months following T1), T3 (12 months following T1)
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.
Time frame: Baseline to T1 (treatment completion -up to 12 weeks), T2 (3 months following T1), T3 (12 months following T1)
Plan to share: Yes — De-identified IPD will be provided to FITBIR. The Department of Defense, in collaboration with the National Institutes of Health, has developed the Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System, a central repository and resource for sharing data to promote collaboration, accelerate research, and advance knowledge on the characterization, prevention, diagnosis, and treatment of TBI. FITBIR provides a common platform and standardized format for data collection, retrieval and archiving, while allowing for flexibility in data entry and analysis.
Time frame: IPD will be provided to FITBIR on an annual basis for 4 years starting in 01 October 2025 to 01 October 2028.
Access criteria: Other researchers conducting research in traumatic brain injury and registered with FITBIR will be able to access de-identified IPD from the study.
Data sharing details ↗ · fitbir.nih.gov
Start is estimated for May 2025; primary completion for Mar 2028, 34 months later.
Of 89 non-industry interventional studies with no phase under Post-Traumatic Headache, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's planned 34 months is above that.
Counting every sponsor, half of 90 studies reached it within 12 months; a quarter within 5 and three quarters within 26.
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