SPINEPASS Physical Therapy for Post-Concussion Headache

(SPINEPASS Trial)

Overseen By Linda A Mrs Linda Marsh, BPhysio

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Queensland

Must not be taking: Botox

Disqualifiers: Cognitive impairment, Relocation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 15

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two different physical therapy methods to help individuals with headaches that persist after a concussion. One method, SPINEPASS, focuses on exercises and therapy to improve spinal movement and self-management of headaches. The other method is standard physical therapy, which includes personalized exercises and advice. Individuals who continue to experience headaches at least four weeks after a concussion, with no recent improvement, might be suitable for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative treatments for persistent headaches.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be willing to limit starting new treatments for post-concussion headaches during the trial.

What prior data suggests that these physical therapy approaches are safe for treating post-concussion headache?

Research has shown that physical therapy is generally safe for treating headaches after a concussion. Studies on physical therapy methods similar to SPINEPASS have demonstrated benefits such as fewer headaches and reduced pain severity. Although specific safety data for SPINEPASS is not yet detailed, physical therapy overall is well-tolerated.

Standard physical therapy, another part of this trial, is also considered safe and is commonly used for these conditions. It includes exercises and techniques to help manage symptoms and improve function with minimal risk of side effects.

In summary, both SPINEPASS and standard physical therapy treatments are expected to be safe, with physical therapy generally having a good safety record for managing post-concussion headaches. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SPINEPASS Physical Therapy because it takes a unique approach to treating post-concussion headaches. Unlike standard physical therapy options, which focus on addressing specific impairments in the cervical, vestibular, or autonomic nervous systems, SPINEPASS emphasizes educating patients about anatomy and biomechanics. This knowledge empowers patients to manage their symptoms through daily exercises integrated into their routines, enhancing spinal mobility and stability. By focusing on self-management and individualized treatment targets, SPINEPASS offers a promising alternative that could improve patient outcomes in a more holistic and sustainable way.

What evidence suggests that this trial's physical therapy approaches could be effective for post-concussion headache?

Research has shown that SPINEPASS Physical Therapy, one of the treatments in this trial, can help individuals with ongoing headaches after a concussion. A recent study found that this therapy reduced the frequency, duration, and intensity of headaches. It also alleviated symptoms related to the autonomic nervous system, which controls functions like heart rate and digestion. SPINEPASS emphasizes self-management by teaching exercises and techniques to manage symptoms as they arise, making it a promising option for those seeking more independent headache management. Meanwhile, the trial will also evaluate Standard Physical Therapy, which addresses impairments or dysfunction in cervical musculoskeletal structures, the vestibular and oculomotor systems, and the autonomic nervous system. ^{1 3 5 6 7}

Who Is on the Research Team?

Amy 0 Dr Amy Bowles, MD

Principal Investigator

Brooke Army Medical Center

Lucy C Dr Lucy Thomas, PhD

Principal Investigator

The University of Queensland

Julia M Dr Julia Treleaven, PhD

Principal Investigator

University of Queensalnd

Are You a Good Fit for This Trial?

This trial is for individuals with persistent headaches following a concussion, lasting at least 4 weeks, who experience autonomic symptoms and have not seen improvement recently. Participants should have moderate to severe headache impact but cannot start other treatments during the study or plan to move away within six months.

Inclusion Criteria

I have had headaches for 4 weeks or more after an injury.

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

Exclusion Criteria

Redeployment/relocation or retirement planned within the next 6 months

Contraindications for spinal or graded general exercise

Cognitive impairment/language barriers affecting ability to participate

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either SPINEPASS or standard physical therapy for up to 12 weeks

12 weeks

Up to 12 sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Follow-up assessments at 3 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• SPINEPASS Physical Therapy
• Standard Physical Therapy

Trial Overview The SPINEPASS clinical trial compares two physical therapy methods: SPINEPASS Physical Therapy aimed at self-managing headaches by targeting autonomic and dura mater function versus Standard Physical Therapy, focusing on reducing headache disability in post-concussion patients.

How Is the Trial Designed?

Group I: SPINEPASS Experimental Treatment 1 Intervention

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.

Group II: Standard Physical Therapy Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

The University of Queensland

Lead Sponsor

Trials

149

Recruited

71,700+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Brooke Army Medical Center

Collaborator

Trials

134

Recruited

28,100+

Published Research Related to This Trial

In a study of 73 children and adolescents undergoing physical therapy after a concussion, 90% exhibited cervical impairments in at least three out of five assessment categories, highlighting the commonality of these issues post-injury.

The most frequently observed impairments were in posture (99%) and myofascial issues (98%), indicating that targeted physical therapy interventions should focus on these areas to effectively address cervical spine impairments following concussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CHARACTERIZATION OF CERVICAL SPINE IMPAIRMENTS IN CHILDREN AND ADOLESCENTS POST-CONCUSSION. Tiwari, D., Goldberg, A., Yorke, A., et al.[2022]

A new treatment-based profiling model has been proposed to assist physical therapists in managing patients after a concussion, focusing on symptom type, intensity, and movement response.

The model emphasizes three key treatment areas: symptom management, movement system optimization, and performance optimization, which can help therapists make informed decisions tailored to individual patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Treatment-Based Profiling Model for Physical Therapy Management of Patients Following a Concussive Event. Alsalaheen, B., Landel, R., Hunter-Giordano, A., et al.[2020]

A 27-year-old professional rugby player with a history of 20 concussions showed significant improvement in post-concussion syndrome after 30 sessions of cervical rehabilitation, with lasting benefits observed over 6 years.

Post-treatment, the player's cervical spinal alignment improved significantly, and he experienced only two additional concussions in the following six years, suggesting that correcting cervical alignment may help reduce the risk of future concussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-concussion syndrome and concussion incidence improved in a pro rugby player following cervical spine rehab: case study and 6-year follow-up. Strauss, S., Lightstone, DF., Fedorchuk, C., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06882239

Study Details | NCT06882239 | SPINEPASS: SPINE Self ... Hypothesis 1.1b: Participants who undergo SPINEPASS will have significantly greater improvements in headache severity (i.e., intensity range, frequency, ...

2. withpower.com withpower.com/trial/phase-post-traumatic-headache-4-2025-3ec4d

SPINEPASS Physical Therapy for Post-Concussion ... In a study of 73 children and adolescents undergoing physical therapy after a concussion, 90% exhibited cervical impairments in at least three out of five ...

3. trial.medpath.com trial.medpath.com/clinical-trial/783ae828df8b31aa/nct06882239-spine-self-management-persistent-headache

SPINE Self-management Techniques for Persistent Headache ... Hypothesis 1.1a: Individuals with PPTH will have significant improvement in headache disability (HIT-6) (primary outcome) following SPINEPASS ...

4. shrs.uq.edu.au shrs.uq.edu.au/spinepass-spine-self-management-techniques-persistent-headache-after-concussion-physical-therapy-targeting-autonomic-and-dura-mater-function

SPINEPASS: SPINE Self-Management Techniques for ... In a recent record review this treatment approach demonstrated improvement in headache frequency, duration and intensity and a decrease in severity of ANS ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9897009/

The Effectiveness of Physical Therapy Interventions for ... This systematic review demonstrates that physical therapy interventions including aerobic exercise and multimodal approaches have been found to be beneficial

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06882239/spinepass-spine-self-management-techniques-for-persistent-headache-after-concussion-physical-therapy-targeting-autonomic-and-dura-mater-function

SPINEPASS: SPINE Self-management Techniques for ... This is a prospective randomized controlled trial comparing two different physical therapy approaches to the treatment of posttraumatic ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10342432/

Post-Traumatic Headache: A Review of Prevalence, Clinical ... PTSD is also a major risk factor of PTH development following a mTBI and could lead to severe headaches due to the psychological burden of the experienced ...