HeadacheNCT04222244
Musculoskeletal Impairment in Headaches Attributed to Rhinosinusitis
An observational study of Headache, run by Des Moines University at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Headache
- How many people
- 82 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 Mar 2020to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: community sample including community members seen in physical therapy clinics where data collection will occur.
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
The Corvallis Clinic
Corvallis, Oregon, 97330
Michael Gray, 541-754-1265
Gary Gray
- Recruiting
Des Moines University
Des Moines, Iowa, 50325
Shannon M Petersen, DScPT, 515-271-1688, shannon.petersen@dmu.edu
- Recruiting
University of Hartford
Hartford, Connecticut, 06117
Brian Swanson, 860-768-5314
- Recruiting
Pain Relief and Physical Therapy
Havertown, Pennsylvania, 19083
Bryan O'Halloran, 610-789-9887, bryano@painrelief-pt.com
- Recruiting
Performance Rehabilitation
Lafayette, New Jersey, 07871
Damon Daura, 973-688-4981
- Recruiting
Performance Rehabilitation
Totowa, New Jersey, 07871
Damon Daura, 973-688-4981
- Recruiting
Youngstown State University
Youngstown, Ohio, 44555
Ken E Learman, PhD, 330-941-7125, klearman@ysu.edu
Ken E Learman, PhD
About this study
Official title: Musculoskeletal Neck Impairment in Headaches Attributed to Rhinosinusitis
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.
Read more
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.
Read the detailed description
Design: Observational, case control Background: A recent study showed neck pain, neck muscle weakness, and limited neck range of motion in individuals who reported having sinus headaches. These impairments are also associated with cervicogenic headaches (headaches originating in the neck), but had not previously been shown in people with sinus headaches.
Because the individuals in this previous study self-diagnosed their sinus headaches, it is possible that they did not have sinus headaches but rather had a different kind of headache. It is unknown whether or not individuals who have been diagnosed with sinus headaches according to diagnostic criteria also present with musculoskeletal impairments.
Purpose 1: The purpose of this study is to determine if musculoskeletal neck impairments are present in individuals diagnosed with headaches attributed to rhinosinusitis (sinus headaches) compared to people without headaches. Question: Do people with diagnosed with headaches attributed to rhinosinusitis have neck pain or impairments in neck strength, neck range of motion, or segmental neck joint mobility compared to people without headaches?
Background for question 2: Upper cervical range of motion can be measured using the flexion-rotation test or the side bend rotation test. The side bend rotation test has been suggested as potentially more useful in individuals with hyper-laxity, however, has not been examined in a symptomatic population.
Purpose 2: To compare the side bend rotation test to the cervical flexion rotation test and manual joint assessment in people with varying degrees of joint laxity. Question: What is the diagnostic accuracy of the side bend rotation test compared to the index tests of the flexion rotation test and manual joint assessment?
- Conditions
- Headache
- Being tested
- No intervention will be administered. We are only performing tests and measures.
- Keywords
- Headache Attributed to Rhinosinusitis, Neck Pain, Musculoskeletal, Cervical, Joint Laxity, Range of Motion, Segmental Mobility, Sinus Headache
- Medical subject headings
- Headache, Neck Pain, Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Headache Attributed to Rhinosinusitis Group (HAR) | No interventions will be provided. Receives: Other: No intervention will be administered. We are only performing tests and measures. | |
| Headache-Free Control Group (Control) | No interventions will be provided. Receives: Other: No intervention will be administered. We are only performing tests and measures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
range of motion
measured with a cervical range of motion device (CROM)
Measured: Day 1
Secondary outcomes (9)
Pain Level
visual analogue scale
Measured: Day 1
disability
Neck Disability Index (self-report questionnaire)
Measured: Day 1
headache impact
Headache Impact Test (self-report questionnaire)
Measured: Day 1
sino-nasal outcome test (SNOT-22)
self-report questionnaire
Measured: Day 1
Cervical side bend rotation test
neck range of motion side bending first, then rotating the head and neck
Measured: Day 1
cervical flexion rotation test
neck range of motion flexing first, then rotating
Measured: Day 1
segmental joint mobility
manual segmental joint examination
Measured: Day 1
neck flexor endurance
neck flexor muscle endurance test in supine
Measured: Day 1
Beighton score
a series of range of motion tests to measure hyper-laxity of joints
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start1 Mar 2020
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Des Moines University
- Sponsor type
- University, hospital or other
- Collaborators
- Texas Tech University, University of Hartford, Youngstown State University, American Academy of Orthopaedic Manual Physical Therapists
- Responsible party
- Sponsor
- Investigators
- Shannon Petersen, PT, Principal investigator, Des Moines University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04222244
- Sponsor's protocol ID
- DesMoinesU
- Status last verified
- Sep 2020
- First submitted
- 6 Jan 2020
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Musculoskeletal Neck Impairment in Headaches Attributed to Rhinosinusitis
- ClinicalTrials.gov ID
- NCT04222244
- Acronym / sponsor ID
- DesMoinesU
- Conditions
- Headache
- Keywords
- Headache Attributed to Rhinosinusitis, Neck Pain, Musculoskeletal, Cervical, Joint Laxity, Range of Motion, Segmental Mobility, Sinus Headache
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Des Moines UniversityUniversity, hospital or other
- Collaborators
- Texas Tech University, University of Hartford, Youngstown State University, American Academy of Orthopaedic Manual Physical Therapists
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 9 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Design: Observational, case control Background: A recent study showed neck pain, neck muscle weakness, and limited neck range of motion in individuals who reported having sinus headaches. These impairments are also associated with cervicogenic headaches (headaches originating in the neck), but had not previously been shown in people with sinus headaches.
Because the individuals in this previous study self-diagnosed their sinus headaches, it is possible that they did not have sinus headaches but rather had a different kind of headache. It is unknown whether or not individuals who have been diagnosed with sinus headaches according to diagnostic criteria also present with musculoskeletal impairments.
Purpose 1: The purpose of this study is to determine if musculoskeletal neck impairments are present in individuals diagnosed with headaches attributed to rhinosinusitis (sinus headaches) compared to people without headaches. Question: Do people with diagnosed with headaches attributed to rhinosinusitis have neck pain or impairments in neck strength, neck range of motion, or segmental neck joint mobility compared to people without headaches?
Background for question 2: Upper cervical range of motion can be measured using the flexion-rotation test or the side bend rotation test. The side bend rotation test has been suggested as potentially more useful in individuals with hyper-laxity, however, has not been examined in a symptomatic population.
Purpose 2: To compare the side bend rotation test to the cervical flexion rotation test and manual joint assessment in people with varying degrees of joint laxity. Question: What is the diagnostic accuracy of the side bend rotation test compared to the index tests of the flexion rotation test and manual joint assessment?
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Headache Attributed to Rhinosinusitis Group (HAR) | – | Other: No intervention will be administered. We are only performing tests and measures.No interventions will be provided. |
| Headache-Free Control Group (Control) | – | Other: No intervention will be administered. We are only performing tests and measures.No interventions will be provided. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- community sample including community members seen in physical therapy clinics where data collection will occur.
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention will be administered. We are only performing tests and measures.No intervention will be administered. We are only performing tests and measures. | Other | Headache Attributed to Rhinosinusitis Group (HAR), Headache-Free Control Group (Control) |
Primary outcome
range of motion
Time frame: Day 1
measured with a cervical range of motion device (CROM)
9 secondary outcomes
Pain Level
Time frame: Day 1
disability
Time frame: Day 1
headache impact
Time frame: Day 1
sino-nasal outcome test (SNOT-22)
Time frame: Day 1
Cervical side bend rotation test
Time frame: Day 1
cervical flexion rotation test
Time frame: Day 1
segmental joint mobility
Time frame: Day 1
neck flexor endurance
Time frame: Day 1
Beighton score
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shannon Petersen, PT principal investigator
Des Moines University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Headache, run by Des Moines University at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shannon Petersen, PT (5152711688, shannon.petersen@dmu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
range of motion (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2020.