Persistent Post-concussive SymptomsSPINEPASSNCT06882239
SPINEPASS: SPINE Self-management Techniques for Persistent Headache After Concussion: Physical Therapy Targeting Autonomic and Dura Mater Function.
A study testing SPINEPASS Physical Therapy and Standard Physical Therapy in people with Persistent Post-concussive Symptoms and Post Traumatic Headache, run by The University of Queensland at 1 site in United States.
Trial 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 efficacy of SPINEPASS against Standard Physical Therapy to reduce headache disability and impact amongst patients with… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Persistent Post-concussive Symptoms, Post Traumatic Headache
- What is being tested?
- SPINEPASS Physical Therapy and Standard Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Brook Army Medical Center
San Antonio, Texas, 78234
Amy o Dr Amy Bowles, MD, 210-916-8693, amy.o.bowles.civ@health.mil
About this study
Official title: SPINEPASS: SPINE Self-management Techniques for Persistent Headache After Concussion: Physical Therapy Targeting Autonomic and Dura Mater Function
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.
Read the 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 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:
- To test SPINEPASS against standard PT in a randomized controlled trial, (RCT), to improve headache disability.
- To understand participants' views on the program compared to standard PT and understand factors contributing to success or failure of these treatment approaches. This will be achieved by evaluating patient self-confidence to manage headache, participants' perceptions of the appropriateness, acceptability, and feasibility of SPINEPASS compared to standard PT, and interviewing the participants.
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].
- Being tested
- SPINEPASS Physical Therapy, Standard Physical Therapy
- Keywords
- Persistent post-concussion headache, autonomic, dura, physical therapy, concussion, military
- Medical subject headings
- Post-Traumatic Headache, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPINEPASS Physical TherapyOther
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.
Standard Physical TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| SPINEPASS | Experimental | 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. Receives: Other: SPINEPASS Physical Therapy |
| Standard Physical Therapy | Active comparator | 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. Receives: Other: Standard Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline; T1 (treatment completion- up to 12 weeks); T2 (3 months post T1)
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline to T1 (treatment completion -up to 12 weeks), T2 (3 months following T1), T3 (12 months following T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start1 May 2025 (estimated)
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Persistent Post-concussive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Collaborators
- Brooke Army Medical Center, United States Department of Defense
- Responsible party
- Principal investigator, Dr Lucy Thomas, The University of Queensland
- Investigators
- Lucy C Dr Lucy Thomas, PhD, Principal investigator, The University of QueenslandJulia M Dr Julia Treleaven, PhD, Principal investigator, University of QueensalndAmy 0 Dr Amy Bowles, MD, Study director, Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882239
- Sponsor's protocol ID
- HT94252410891
- Other IDs
- CDMRP-TP230313
- Acronym
- SPINEPASS
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Patricios JS, Schneider KJ, Dvorak J, Ahmed OH, Blauwet C, Cantu RC, Davis GA, Echemendia RJ, Makdissi M, McNamee M, Broglio S, Emery CA, Feddermann-Demont N, Fuller GW, Giza CC, Guskiewicz KM, Hainline B, Iverson GL, Kutcher JS, Leddy JJ, Maddocks D, Manley G, McCrea M, Purcell LK, Putukian M, Sato H, Tuominen MP, Turner M, Yeates KO, Herring SA, Meeuwisse W. Consensus statement on concussion in sport: the 6th International Conference on Concussion in Sport-Amsterdam, October 2022. Br J Sports Med. 2023 Jun;57(11):695-711. doi: 10.1136/bjsports-2023-106898.
PubMed 37316210Schneider KJ, Critchley ML, Anderson V, Davis GA, Debert CT, Feddermann-Demont N, Gagnon I, Guskiewicz KM, Hayden KA, Herring S, Johnstone C, Makdissi M, Master CL, Moser RS, Patricios JS, Register-Mihalik JK, Ronksley PE, Silverberg ND, Yeates KO. Targeted interventions and their effect on recovery in children, adolescents and adults who have sustained a sport-related concussion: a systematic review. Br J Sports Med. 2023 Jun;57(12):771-779. doi: 10.1136/bjsports-2022-106685.
PubMed 37316188Bartsch T, Goadsby PJ. Increased responses in trigeminocervical nociceptive neurons to cervical input after stimulation of the dura mater. Brain. 2003 Aug;126(Pt 8):1801-13. doi: 10.1093/brain/awg190. Epub 2003 Jun 23.
PubMed 12821523Sillevis R, Hogg R. Anatomy and clinical relevance of sub occipital soft tissue connections with the dura mater in the upper cervical spine. PeerJ. 2020 Aug 10;8:e9716. doi: 10.7717/peerj.9716. eCollection 2020.
PubMed 32864219Fazliogullari Z, Kilic C, Karabulut AK, Yazar F. A morphometric analysis of the superior cervical ganglion and its surrounding structures. Surg Radiol Anat. 2016 Apr;38(3):299-302. doi: 10.1007/s00276-015-1551-3. Epub 2015 Sep 12.
PubMed 26364034Esterov D, Greenwald BD. Autonomic Dysfunction after Mild Traumatic Brain Injury. Brain Sci. 2017 Aug 11;7(8):100. doi: 10.3390/brainsci7080100.
PubMed 28800081Howard L, Dumkrieger G, Chong CD, Ross K, Berisha V, Schwedt TJ. Symptoms of Autonomic Dysfunction Among Those With Persistent Posttraumatic Headache Attributed to Mild Traumatic Brain Injury: A Comparison to Migraine and Healthy Controls. Headache. 2018 Oct;58(9):1397-1407. doi: 10.1111/head.13396. Epub 2018 Aug 29.
PubMed 30156267Goodrich GL, Flyg HM, Kirby JE, Chang CY, Martinsen GL. Mechanisms of TBI and visual consequences in military and veteran populations. Optom Vis Sci. 2013 Feb;90(2):105-12. doi: 10.1097/OPX.0b013e31827f15a1.
PubMed 23314131
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPINEPASS: SPINE Self-management Techniques for Persistent Headache After Concussion: Physical Therapy Targeting Autonomic and Dura Mater Function
- ClinicalTrials.gov ID
- NCT06882239
- Acronym / sponsor ID
- SPINEPASS / HT94252410891
- Keywords
- Persistent post-concussion headache, autonomic, dura, physical therapy, concussion, military
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Collaborators
- Brooke Army Medical Center, United States Department of Defense
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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:
- To test SPINEPASS against standard PT in a randomized controlled trial, (RCT), to improve headache disability.
- To understand participants' views on the program compared to standard PT and understand factors contributing to success or failure of these treatment approaches. This will be achieved by evaluating patient self-confidence to manage headache, participants' perceptions of the appropriateness, acceptability, and feasibility of SPINEPASS compared to standard PT, and interviewing the participants.
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].
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPINEPASS | Experimental | Other: SPINEPASS Physical TherapyThe 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. |
| Standard Physical Therapy | Active comparator | Other: Standard Physical TherapyParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- Contraindications for spinal or graded general exercise.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPINEPASS Physical TherapySPINEPASS 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 |
| Standard Physical TherapyThe 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 |
Primary outcome
Headache Impact Test (HIT-6)
Time frame: Baseline to T1 (treatment completion -up to 12 weeks), T2 (3 months following T1), T3 (12 months following T1)
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
Time frame: Baseline; T1 (treatment completion- up to 12 weeks); T2 (3 months post T1)
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.
2 secondary outcomes
Composite Autonomic Symptom Score (COMPASS-31)
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).
Time frame: Baseline to T1 (treatment completion -up to 12 weeks), T2 (3 months following T1), T3 (12 months following T1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Background: PubMed 37316210Patricios JS, Schneider KJ, Dvorak J, Ahmed OH, Blauwet C, Cantu RC, Davis GA, Echemendia RJ, Makdissi M, McNamee M, Broglio S, Emery CA, Feddermann-Demont N, Fuller GW, Giza CC, Guskiewicz KM, Hainline B, Iverson GL, Kutcher JS, Leddy JJ, Maddocks D, Manley G, McCrea M, Purcell LK, Putukian M, Sato H, Tuominen MP, Turner M, Yeates KO, Herring SA, Meeuwisse W. Consensus statement on concussion in sport: the 6th International Conference on Concussion in Sport-Amsterdam, October 2022. Br J Sports Med. 2023 Jun;57(11):695-711. doi: 10.1136/bjsports-2023-106898.
- Background: PubMed 37316188Schneider KJ, Critchley ML, Anderson V, Davis GA, Debert CT, Feddermann-Demont N, Gagnon I, Guskiewicz KM, Hayden KA, Herring S, Johnstone C, Makdissi M, Master CL, Moser RS, Patricios JS, Register-Mihalik JK, Ronksley PE, Silverberg ND, Yeates KO. Targeted interventions and their effect on recovery in children, adolescents and adults who have sustained a sport-related concussion: a systematic review. Br J Sports Med. 2023 Jun;57(12):771-779. doi: 10.1136/bjsports-2022-106685.
- Background: PubMed 12821523Bartsch T, Goadsby PJ. Increased responses in trigeminocervical nociceptive neurons to cervical input after stimulation of the dura mater. Brain. 2003 Aug;126(Pt 8):1801-13. doi: 10.1093/brain/awg190. Epub 2003 Jun 23.
- Background: PubMed 32864219Sillevis R, Hogg R. Anatomy and clinical relevance of sub occipital soft tissue connections with the dura mater in the upper cervical spine. PeerJ. 2020 Aug 10;8:e9716. doi: 10.7717/peerj.9716. eCollection 2020.
- Background: PubMed 26364034Fazliogullari Z, Kilic C, Karabulut AK, Yazar F. A morphometric analysis of the superior cervical ganglion and its surrounding structures. Surg Radiol Anat. 2016 Apr;38(3):299-302. doi: 10.1007/s00276-015-1551-3. Epub 2015 Sep 12.
- Background: PubMed 28800081Esterov D, Greenwald BD. Autonomic Dysfunction after Mild Traumatic Brain Injury. Brain Sci. 2017 Aug 11;7(8):100. doi: 10.3390/brainsci7080100.
- Background: PubMed 30156267Howard L, Dumkrieger G, Chong CD, Ross K, Berisha V, Schwedt TJ. Symptoms of Autonomic Dysfunction Among Those With Persistent Posttraumatic Headache Attributed to Mild Traumatic Brain Injury: A Comparison to Migraine and Healthy Controls. Headache. 2018 Oct;58(9):1397-1407. doi: 10.1111/head.13396. Epub 2018 Aug 29.
- Background: PubMed 23314131Goodrich GL, Flyg HM, Kirby JE, Chang CY, Martinsen GL. Mechanisms of TBI and visual consequences in military and veteran populations. Optom Vis Sci. 2013 Feb;90(2):105-12. doi: 10.1097/OPX.0b013e31827f15a1.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lucy C Dr Lucy Thomas, PhD principal investigator
The University of Queensland
Julia M Dr Julia Treleaven, PhD principal investigator
University of Queensalnd
Amy 0 Dr Amy Bowles, MD study director
Brooke Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPINEPASS Physical Therapy and Standard Physical Therapy in people with Persistent Post-concussive Symptoms and Post Traumatic Headache, run by The University of Queensland at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lucy C Dr Lucy Thomas, PhD (+61 336 51644, l.thomas2@uq.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache Impact Test (HIT-6) (time frame: Baseline to T1 (treatment completion -up to 12 weeks), T2 (3 months following T1), T3 (12 months following T1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06882239, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.