NCT06859463

Brief Summary

This cross-sectional study aims to compare muscle function of the neck, and shoulder and muscle tenderness in three groups of headache patients: migraine, tension-type headache, and posttraumatic headache. The study will evaluate muscle tenderness through the Total Tenderness Score (TTS) and muscle function through maximum voluntary isometric contraction (MVIC) and rate of force development (RFD). Additionally, functional assessments such as the Cranio-Cervical Flexion Test (CCFT) and Ito Test will be performed.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

February 28, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 5, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

March 10, 2025

Status Verified

February 1, 2025

Enrollment Period

6 months

First QC Date

February 28, 2025

Last Update Submit

March 5, 2025

Conditions

MigraineTension HeadachePosttraumatic Headache

Outcome Measures

Primary Outcomes (1)

  • Primary Outcome Measure: 1.Rate of Force Development (RFD)

    Rate of Force Development (RFD) of the shoulder elevation Maximum voluntary isometric contraction performed "as fast and hard as possible" using a custom dynamometer for the shoulder elevation movement.

    1 year

Study Arms (3)

Migraine patients Migraine patients with at least 10 days per month of headache

Tensional-type headache patients Tensional-type headache patients with at least 10 days per month of headache.

Device: Muscle function

Posttraumatic headache patients Posttraumatic headache patients with at least 10 days per month of h

Device: Muscle function

Tensional-type headache patients Tensional-type headache patients with at least 10 days per month of

Device: Muscle function

Interventions

Muscle functionDEVICE

Functional evaluation First, the patients will fill the Fysisk Aktivitet Questionnaire, the o Klinisk Oral Fysiologi (KU) Questionnaire and the Harvard Trauma Questionnaire. Then, the evaluator will applicate the Total Tenderness Score (TTS) for evaluating their tenderness in different spots of the head and neck regions. The next evaluation comprehends the evaluation of the maximal voluntary isometric contraction (MVIC) for the different neck movements and the rate of force development (RFD) of the shoulder elevation. After this, patients will perform the cranio-cervical flexion test (CCFT), and, finally, the Ito test to evaluate the lumbar endurance.

Migraine patients Migraine patients with at least 10 days per month of headachePosttraumatic headache patients Posttraumatic headache patients with at least 10 days per month of hTensional-type headache patients Tensional-type headache patients with at least 10 days per month of

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Migraine, tensional-type headache, and posttraumatic headache patients who are between 18-65 years old and have at least 10 days of headache per month

You may qualify if:

  • Aged 18 to 65 years.
  • Diagnosis of migraine, tension-type headache, or posttraumatic headache, occurring at least 10 days per month.
  • For tension-type headache patients, maximum of 3 days per month with migraine.

You may not qualify if:

  • Pregnancy.
  • Significant psychiatric comorbidities (e.g., severe depression).
  • Medication-overuse headache.
  • Severe osteoarthritis in the neck or shoulder, or cervical disc herniation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danish Headache Center

Copenhagen, Region H, 2600, Denmark

Location

MeSH Terms

Conditions

Migraine DisordersTension-Type HeadachePost-Traumatic Headache

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHeadache Disorders, Secondary

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physiotherapist ph.d

Study Record Dates

First Submitted

February 28, 2025

First Posted

March 5, 2025

Study Start

February 28, 2025

Primary Completion

September 1, 2025

Study Completion

March 1, 2026

Last Updated

March 10, 2025

Record last verified: 2025-02

Locations

DK(1)