Validating a Modified COMPASS 31questionnaire for Treatment Outcomes

NCT ID: NCT05302479

Last Updated: 2022-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-15

Study Completion Date

2023-09-20

Brief Summary

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Eligible participants will complete the COMPASS 31 (year), modified COMPASS 31(one month) and the NSI (one month) questionnaires at baseline and complete the modified COMPASS 31 and the NSI after usual care of treatment.

The investigators will

1. Compare results for the COMPASS 31(year) to the modified COMPASS 31(month) at baseline.
2. Compare modified COMPASS 31(month) to the NSI at baseline and post intervention.

Detailed Description

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The Composite Autonomic Symptom Score (COMPASS 31) is a validated questionnaire designed to measure self reported autonomic symptoms in the last year in individuals with migraine and post-concussive symptoms. In order to use this questionnaire to measure response to treatment it would be preferable to determine if the results of the COMPASS 31 are similar if the patient is asked to complete this thinking about symptoms in the last year as per the usual questionnaire, compared to a modified COMPASS 31 where symptoms in the past month will be assessed.

This prospective trial will compare results of the COMPASS 31 (year) to the modified COMPASS 31 (month). Since the present gold standard for outcome measures in post-concussive treatment is the neurobehavioral symptom inventory (NSI), this study will also compare results of the modified COMPASS 31(month) to the NSI outcome measure at baseline and post treatment to validate the utilization of the modified version of the COMPASS 31(month) for use in the post-concussive population as an outcome measure for self-reported autonomic nervous system symptoms.

Conditions

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Headache, Migraine Persistent Post Traumatic Headache Cervicogenic Headache

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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COMPASS 31 questionnaire

A 31 question questionnaire that measures autonomic symptoms.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients who present to the BAMC\_BIRS clinic for treatment of headache between the ages of 18-64.

Exclusion Criteria

* Normal composite autonomic symptom score.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Defense and Veterans Brain Injury Center

FED

Sponsor Role collaborator

The University of Queensland

OTHER

Sponsor Role collaborator

Brooke Army Medical Center

FED

Sponsor Role lead

Responsible Party

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Matt Hammerle

Doctor of Physical Therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matt H Hammerle, DPT

Role: PRINCIPAL_INVESTIGATOR

BAMC-BIRS

Locations

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Brooke Army Medical Centre

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Matt H Hammerle, DPT

Role: CONTACT

210-916-8693

Lisa H Lu, PhD

Role: CONTACT

210-916-6029

Facility Contacts

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Matt Hammerle

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 30156267 (View on PubMed)

King PR, Donnelly KT, Donnelly JP, Dunnam M, Warner G, Kittleson CJ, Bradshaw CB, Alt M, Meier ST. Psychometric study of the Neurobehavioral Symptom Inventory. J Rehabil Res Dev. 2012;49(6):879-88. doi: 10.1682/jrrd.2011.03.0051.

Reference Type BACKGROUND
PMID: 23299259 (View on PubMed)

Other Identifiers

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C.2021.128e

Identifier Type: -

Identifier Source: org_study_id

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