SPINEPASS: SPINE Self-management Techniques for Persistent Headache After Concussion: Physical Therapy Targeting Autonomic and Dura Mater Function.
NCT ID: NCT06882239
Last Updated: 2025-03-18
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
120 participants
INTERVENTIONAL
2025-05-01
2028-09-30
Brief Summary
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Detailed Description
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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:
1. To test SPINEPASS against standard PT in a randomized controlled trial, (RCT), to improve headache disability.
2. 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 \[themes from qualitative interview\].
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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SPINEPASS
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.
SPINEPASS 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.
Standard 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.
Standard Physical Therapy
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.
Interventions
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SPINEPASS 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.
Standard Physical Therapy
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.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Brooke Army Medical Center
FED
United States Department of Defense
FED
The University of Queensland
OTHER
Responsible Party
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Dr Lucy Thomas
Principal Investigator
Principal Investigators
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Lucy C Dr Lucy Thomas, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Queensland
Julia M Dr Julia Treleaven, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Queensalnd
Amy 0 Dr Amy Bowles, MD
Role: STUDY_DIRECTOR
Brooke Army Medical Center
Locations
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Brook Army Medical Center
San Antonio, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Schneider 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.
Bartsch 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.
Sillevis 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.
Fazliogullari 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.
Esterov D, Greenwald BD. Autonomic Dysfunction after Mild Traumatic Brain Injury. Brain Sci. 2017 Aug 11;7(8):100. doi: 10.3390/brainsci7080100.
Howard 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.
Goodrich 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.
Other Identifiers
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CDMRP-TP230313
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
HT94252410891
Identifier Type: -
Identifier Source: org_study_id
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