Musculoskeletal Impairment in Headaches Attributed to Rhinosinusitis

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.

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.

Study Overview

• Status: Unknown
• Conditions: Headache
• Intervention / Treatment: Other: No intervention will be administered. We are only performing tests and measures.

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 Type: Observational
• Enrollment (Anticipated): 82

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06117
      • Recruiting
      • University of Hartford
      • Contact: Brian Swanson; Phone Number: 860-768-5314
  • Iowa
    • Des Moines, Iowa, United States, 50325
      • Recruiting
      • Des Moines University
      • Contact: Shannon M Petersen, DScPT; Phone Number: 515-271-1688; Email: shannon.petersen@dmu.edu
  • New Jersey
    • Lafayette, New Jersey, United States, 07871
      • Recruiting
      • Performance Rehabilitation
      • Contact: Damon Daura; Phone Number: 973-688-4981
    • Totowa, New Jersey, United States, 07871
      • Recruiting
      • Performance Rehabilitation
      • Contact: Damon Daura; Phone Number: 973-688-4981
  • Ohio
    • Youngstown, Ohio, United States, 44555
      • Recruiting
      • Youngstown State University
      • Contact: Ken E Learman, PhD; Phone Number: 330-941-7125; Email: klearman@ysu.edu
      • Principal Investigator: Ken E Learman, PhD
  • Oregon
    • Corvallis, Oregon, United States, 97330
      • Recruiting
      • The Corvallis Clinic
      • Contact: Michael Gray; Phone Number: 541-754-1265
      • Sub-Investigator: Gary Gray
  • Pennsylvania
    • Havertown, Pennsylvania, United States, 19083
      • Recruiting
      • Pain Relief and Physical Therapy
      • Contact: Bryan O'Halloran; Phone Number: 610-789-9887; Email: bryano@painrelief-pt.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Headache Attributed to Rhinosinusitis Group (HAR); No interventions will be provided.	Other: No intervention will be administered. We are only performing tests and measures.; 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.; No intervention will be administered. We are only performing tests and measures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
range of motion	measured with a cervical range of motion device (CROM)	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Level	visual analogue scale	Day 1
disability	Neck Disability Index (self-report questionnaire)	Day 1
headache impact	Headache Impact Test (self-report questionnaire)	Day 1
sino-nasal outcome test (SNOT-22)	self-report questionnaire	Day 1
Cervical side bend rotation test	neck range of motion side bending first, then rotating the head and neck	Day 1
cervical flexion rotation test	neck range of motion flexing first, then rotating	Day 1
segmental joint mobility	manual segmental joint examination	Day 1
neck flexor endurance	neck flexor muscle endurance test in supine	Day 1
Beighton score	a series of range of motion tests to measure hyper-laxity of joints	Day 1

Collaborators and Investigators

• Sponsor: Des Moines University
• Collaborators: Texas Tech University; Youngstown State University; American Academy of Orthopaedic Manual Physical Therapists; University of Hartford
• Investigators: Principal Investigator: Shannon Petersen, PT, Des Moines University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: January 6, 2020
• First Submitted That Met QC Criteria: January 7, 2020
• First Posted (Actual): January 9, 2020

Study Record Updates

• Last Update Posted (Actual): September 18, 2020
• Last Update Submitted That Met QC Criteria: September 17, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Cervical; Neck Pain; Range of Motion; Musculoskeletal; Headache Attributed to Rhinosinusitis; Joint Laxity; Segmental Mobility; Sinus Headache
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Headache
• Other Study ID Numbers: DesMoinesU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No