Recruiting

Observational Study

Sponsor:

Des Moines University

Code:

NCT04222244

Conditions

Headache

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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.

Conditions

Headache

Study ID

NCT04222244

Start date

Mar 1, 2020

Status verified date

Sep, 2020

Completion date

Dec 1, 2022

Anticipated

Primary completion date

Dec 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion criteria for the headache attributed to rhinosinusitis (HAR) group:

  • 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)

Exclusion criteria for the HAR group:

  • 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.

Exclusion criteria for the non-headache group (NHA):

  • Any history of headaches for which they have sought medical care

Study Design

Enrollment

82 participants

Anticipated

Interventions and Outcome Measures

Arms

Headache Attributed to Rhinosinusitis Group (HAR)

No interventions will be provided.

Headache-Free Control Group (Control)

No interventions will be provided.

Interventions

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

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

Primary outcome measure

  • range of motion [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Locations

University of Hartford

Recruiting

Hartford, Connecticut, United States, 06117

Contacts

Brian Swanson

860-768-5314

Des Moines University

Recruiting

Des Moines, Iowa, United States, 50325

Contacts

Shannon M Petersen, DScPT

515-271-1688shannon.petersen@dmu.edu

Performance Rehabilitation

Recruiting

Lafayette, New Jersey, United States, 07871

Contacts

Damon Daura

973-688-4981

Performance Rehabilitation

Recruiting

Totowa, New Jersey, United States, 07871

Contacts

Damon Daura

973-688-4981

Youngstown State University

Recruiting

Youngstown, Ohio, United States, 44555

Contacts

Principal Investigator:

Ken E Learman, PhD

The Corvallis Clinic

Recruiting

Corvallis, Oregon, United States, 97330

Contacts

Michael Gray

541-754-1265

Pain Relief and Physical Therapy

Recruiting

Havertown, Pennsylvania, United States, 19083

Contacts

More Information

Sponsor

Des Moines University

Last update posted

Sep 18, 2020

Last verified

Sep, 2020

Keywords

  • Headache Attributed to Rhinosinusitis
  • Neck Pain
  • Musculoskeletal
  • Cervical
  • Joint Laxity
  • Range of Motion
  • Segmental Mobility
  • Sinus Headache

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Des Moines University on 2020-09-18.