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

120 Participants Needed

Trial Summary

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 data supports the effectiveness of the SPINEPASS Physical Therapy treatment for post-concussion headache?

Research suggests that physical therapy, including treatments targeting the cervical spine (neck area), can help improve symptoms in patients with post-concussion syndrome. This is supported by studies showing improvements in post-concussion symptoms and reduced concussion incidence following cervical spine rehabilitation. ^{1 2 3 4 5}

Is SPINEPASS Physical Therapy safe for treating post-concussion headaches?

The research does not provide specific safety data for SPINEPASS Physical Therapy, but physical therapy is generally considered safe for treating post-traumatic headaches, as it is often recommended alongside other treatments like medication and cognitive therapy. ^{6 7 8 9 10}

How does SPINEPASS Physical Therapy differ from other treatments for post-concussion headache?

SPINEPASS Physical Therapy is unique because it focuses on addressing cervical musculoskeletal dysfunction, which is often present in post-concussion headaches. This approach includes precise physical examination and treatment of the cervical spine, which may not be a focus in standard physical therapy for post-concussion symptoms. ^{1 2 11 12 13}

What is the purpose of this trial?

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.

Research Team

Julia M Dr Julia Treleaven, PhD

Principal Investigator

University of Queensalnd

Amy 0 Dr Amy Bowles, MD

Principal Investigator

Brooke Army Medical Center

Lucy C Dr Lucy Thomas, PhD

Principal Investigator

The University of Queensland

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The University of Kansas Health System Outpatient Clinical Concussion Comprehensive Protocol: An Interdisciplinary Approach. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

An Exploration of the Impact of Initial Timing of Physical Therapy on Safety and Outcomes After Concussion in Adolescents. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

CHARACTERIZATION OF CERVICAL SPINE IMPAIRMENTS IN CHILDREN AND ADOLESCENTS POST-CONCUSSION. [2022]

4. England 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. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

A Treatment-Based Profiling Model for Physical Therapy Management of Patients Following a Concussive Event. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Post-Traumatic Headache: A Review of Prevalence, Clinical Features, Risk Factors, and Treatment Strategies. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Enhanced education for adult patients with persistent post-concussion headaches: a randomized controlled trial. [2023]

8. Georgia (Republic) pubmed.ncbi.nlm.nih.gov

POST-TRAUMATIC HEADACHE. CURRENT VIEWS ON PATHOPHYSIOLOGICAL MECHANISMS OF DEVELOPMENT AND CLINICAL SPECIFICS (REVIEW). [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Demographics and treatment of adolescent posttraumatic headache in a regional concussion clinic. [2015]

10. United States pubmed.ncbi.nlm.nih.gov

Interventional Treatment for Post-traumatic Headache. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Posttraumatic headache: a review. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Sport-Related Headache. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Cervical musculoskeletal dysfunction in post-concussional headache. [2017]