Differences in Characteristics of Headache Patients With a Positive or Negative FRT: a Cross-sectional Comparison.

NCT06134791 | Recruiting

• 1 other identifier: BC-10474 AM2
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

An observational study will be conducted to evaluate the differences in headache characteristics between a subgroup of cervicogenic headache patients with a positive and negative flexion-rotation test at the C1-C2 level. Differences may guide future treatment allocation and the use of more individualized treatment options.

Conditions

Headache

Outcome Measures

Primary Outcomes (7)

• Headache pain intensity

  Subjects will have to report their actual pain complaints on a numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (worst pain) at baseline testing.

  Baseline

• Headache frequency

  Frequency of headache attacks will be registered

  Baseline

• Headache duration

  Duration of headache attacks will be registered

  Baseline

• Headache related disability

  Headache related disability will be questioned using the Henry Ford Headache Disability Index (HDI). The total score ranges from 0-100. The higher the score, the more disabilitating the headache is for the patient.

  Baseline

• Headache related impact

  Headache related disability will be questioned using the Headache Impact Test (HIT-6) questionnaire. The total score can range from 36 to 78, with a higher score indicating the headache has more impact on daily life.

  Baseline

• Neck pain intensity

  Subjects will have to report their actual pain complaints on a numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (worst pain) at baseline testing.

  Baseline

• Neck disability

  Neck pain related disability will be questioned using the NDI (Neck Disability Index). The total score ranges from 0 to 50, with a higher score indicating more disability.

  Baseline

Secondary Outcomes (8)

• Pain Pressure Thresholds (PPTs)

  Baseline

• Joint Position Error

  Baseline

• Global active range of motion of the cervical spine.

  Baseline

• Motor control of the cervical spine (craniocervical flexion test)

  Baseline

• Psychosocial headache related parameters: central sensitization by using the Central Sensitization Index (CSI).

  Baseline

Study Arms (2)

Cervicogenic headache with positive flexion-rotation test

Diagnosis of cervicogenic headache according to the ICHD-3 criteria. Age: 18+ years Headache for at least 1 day/week for at least 3 months Limited mobility of the neck Positive flexion-rotation test (\<32 degrees on the left/right side or a difference of 10 degrees or more between left and right side) NPRS \> 3/10

Other: No intervention

Cervicogenic headache without positive flexion-rotation test

Diagnosis of cervicogenic headache according to the ICHD-3 criteria Age: 18+ years Headache for at least 1 day/week for at least 3 months Limited mobility of the neck Negative flexion-rotation test (\>32 degrees on the left/right side or a difference of less than 10 degrees between left and right side) NPRS \> 3/10

Other: No intervention

Interventions

No intervention OTHER

No intervention

Cervicogenic headache with positive flexion-rotation test; Cervicogenic headache without positive flexion-rotation test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with chronic headache, compliant to the ICHD-3 criteria for cervicogenic headache.

You may qualify if:

• Diagnosis of cervicogenic headache according to the ICHD-3 criteria:
• A. Any headache fulfilling criterion C B. Clinical and/or imaging evidence1 of a disorder or lesion within the cervical spine or soft tissues of the neck, known to be able to cause headache2
• C. Evidence of causation demonstrated by at least two of the following:
• headache has developed in temporal relation to the onset of the cervical disorder or appearance of the lesion
• headache has significantly improved or resolved in parallel with improvement in or resolution of the cervical disorder or lesion
• cervical range of motion is reduced, and headache is made significantly worse by provocative manœuvres
• headache is abolished following diagnostic blockade of a cervical structure or its nerve supply D. Not better accounted for by another ICHD-3 diagnosis
• Age: 18+ years Headache for at least 1 day/week for at least 3 months Limited mobility of the neck NPRS \> 3/10

You may not qualify if:

• Primary headache forms: migraine, TTH
• Other secondary headaches that do not comply with the ICDH-3 criteria for CH
• Whiplash or other traumatic incident in the past
• Pregnancy or given birth in the last year
• Previous head, neck or shoulder surgery
• Cervical radiculopathy complaints
• Receiving other treatments for headache or neck pain (physical therapy/ostheopathy/chiropraxie...) in the previous month

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

University Ghent - campus UZ Ghent - Rehabilitation Sciences B3

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Headache

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Barbara Cagnie, Prof. dr.

  University Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara Cagnie, Prof. dr.

CONTACT

+32 9 332 52 6; Barbara.Cagnie@Ugent.be

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: November 18, 2023
• Study Start: July 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)