SPINEPASS: SPINE Self-management Techniques for Persistent Headache After Concussion: Physical Therapy Targeting Autonomic and Dura Mater Function.

NCT06882239 | Not Yet Recruiting

• 2 other identifiers: HT94252410891CDMRP-TP230313
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Persistent Post-concussive Symptoms; Post Traumatic Headache

Keywords

Persistent post-concussion headache; autonomic; dura; physical therapy; concussion; military

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline; T1 (treatment completion- up to 12 weeks); T2 (3 months post T1)

Secondary Outcomes (2)

• Composite Autonomic Symptom Score (COMPASS-31)

  Baseline to T1 (treatment completion -up to 12 weeks), T2 (3 months following T1), T3 (12 months following T1)

• Neurobehavioral Symptom Inventory (NSI).

  Baseline to T1 (treatment completion -up to 12 weeks), T2 (3 months following T1), T3 (12 months following T1)

Study Arms (2)

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.

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.

Other: Standard Physical Therapy

Interventions

SPINEPASS Physical Therapy OTHER

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

Standard Physical Therapy OTHER

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Queensland: lead
• Brooke Army Medical Center: collaborator
• United States Department of Defense: collaborator

Study Sites (1)

Brook Army Medical Center

San Antonio, Texas, 78234, United States

Location

Related Publications (8)

• 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.

  PMID: 37316210 BACKGROUND

• 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.

  PMID: 37316188 BACKGROUND

• 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.

  PMID: 12821523 BACKGROUND

• 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.

  PMID: 32864219 BACKGROUND

• 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.

  PMID: 26364034 BACKGROUND

• Esterov D, Greenwald BD. Autonomic Dysfunction after Mild Traumatic Brain Injury. Brain Sci. 2017 Aug 11;7(8):100. doi: 10.3390/brainsci7080100.

  PMID: 28800081 BACKGROUND

• 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.

  PMID: 30156267 BACKGROUND

• 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.

  PMID: 23314131 BACKGROUND

MeSH Terms

Conditions

Post-Traumatic Headache; Brain Concussion

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Injuries, Traumatic; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Lucy C Dr Lucy Thomas, PhD

  The University of Queensland

  PRINCIPAL INVESTIGATOR

• Julia M Dr Julia Treleaven, PhD

  University of Queensalnd

  PRINCIPAL INVESTIGATOR

• Amy 0 Dr Amy Bowles, MD

  Brooke Army Medical Center

  STUDY DIRECTOR

Central Study Contacts

Lucy C Dr Lucy Thomas, PhD

CONTACT

+61 336 51644; l.thomas2@uq.edu.au

Linda A Mrs Linda Marsh, BPhysio

CONTACT

+61 336 51644; l.marsh@uq.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: March 18, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: March 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (1)