NCT04222244

Brief Summary

Neck pain, neck muscle weakness, and limited neck range of motion have been shown in individuals with sinus headaches. Individuals in this previous study self-diagnosed their sinus headaches. It is unknown whether or not individuals who have been diagnosed with sinus headaches according to diagnostic criteria also present with musculoskeletal impairments. The purpose of this study is to determine if musculoskeletal neck impairments are present in individuals diagnosed with headaches attributed to rhinosinusitis compared to people without headaches. Upper cervical range of motion can be measured using different tests. The side bend rotation test has been suggested as potentially more useful than the flexion rotation test in individuals with hyper-laxity, however, has not been examined in a symptomatic population. A secondary purpose is to compare the side bend rotation test to the cervical flexion rotation test in people with varying degrees of joint laxity.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Typical duration for all trials

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 9, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

September 18, 2020

Status Verified

September 1, 2020

Enrollment Period

2.8 years

First QC Date

January 6, 2020

Last Update Submit

September 17, 2020

Conditions

Headache

Keywords

Headache Attributed to RhinosinusitisNeck PainMusculoskeletalCervicalJoint LaxityRange of MotionSegmental MobilitySinus Headache

Outcome Measures

Primary Outcomes (1)

  • range of motion

    measured with a cervical range of motion device (CROM)

    Day 1

Secondary Outcomes (9)

  • Pain Level

    Day 1

  • disability

    Day 1

  • headache impact

    Day 1

  • sino-nasal outcome test (SNOT-22)

    Day 1

  • Cervical side bend rotation test

    Day 1

  • +4 more secondary outcomes

Study Arms (2)

Headache Attributed to Rhinosinusitis Group (HAR)

No interventions will be provided.

Other: No intervention will be administered. We are only performing tests and measures.

Headache-Free Control Group (Control)

No interventions will be provided.

Other: No intervention will be administered. We are only performing tests and measures.

Interventions

No intervention will be administered. We are only performing tests and measures.OTHER

No intervention will be administered. We are only performing tests and measures.

Headache Attributed to Rhinosinusitis Group (HAR)Headache-Free Control Group (Control)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

community sample including community members seen in physical therapy clinics where data collection will occur.

You may qualify if:

  • HAR has been present for at least 12 weeks OR
  • Participant has had at least 4 HAR over the past 12 months without persistent symptoms between (chronic or recurrent)
  • Diagnosis of headache attributed to rhinosinusitis (or sinus headaches) according to International Classification of Headache Disorders (ICHD-3)

You may not qualify if:

  • History of surgery to the cervical spine
  • Whiplash injury within the past 5 years or any persistent symptoms attributable to a whiplash associated disorder
  • Diagnosis of any headache type other than sinus headache with exception of an occasional, mild headache for which they have not sought medical care.
  • Any history of headaches for which they have sought medical care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of Hartford

Hartford, Connecticut, 06117, United States

RECRUITING

Des Moines University

Des Moines, Iowa, 50325, United States

RECRUITING

Performance Rehabilitation

Lafayette, New Jersey, 07871, United States

RECRUITING

Performance Rehabilitation

Totowa, New Jersey, 07871, United States

RECRUITING

Youngstown State University

Youngstown, Ohio, 44555, United States

RECRUITING

The Corvallis Clinic

Corvallis, Oregon, 97330, United States

RECRUITING

Pain Relief and Physical Therapy

Havertown, Pennsylvania, 19083, United States

RECRUITING

MeSH Terms

Conditions

HeadacheNeck PainJoint Instability

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsJoint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Shannon Petersen, PT

    Des Moines University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shannon Petersen, PT

CONTACT

5152711688shannon.petersen@dmu.edu

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2020

First Posted

January 9, 2020

Study Start

March 1, 2020

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

September 18, 2020

Record last verified: 2020-09

Locations

US(7)