Muscle Function and Tenderness Differences in Headache Patients

Muscle Function and Tenderness in Migraine, Tension-Type Headache, and Posttraumatic Headache Patients: a Cross-Sectional Study

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Migraine; Posttraumatic Headache; Tension Headache
• Intervention / Treatment: Device: Muscle function

• Study Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

Study Locations

• Denmark
  • Region H
    • Copenhagen, Region H, Denmark, 2600
      • Danish Headache Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability 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

Description

Inclusion Criteria:Criteria: Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.
Posttraumatic headache patients Posttraumatic headache patients with at least 10 days per month of h	Device: Muscle function; 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.
Tensional-type headache patients Tensional-type headache patients with at least 10 days per month of	Device: Muscle function; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Danish Headache Center

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2025
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: February 28, 2025
• First Submitted That Met QC Criteria: February 28, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Headache Disorders, Secondary; Migraine Disorders; Headache; Post-Traumatic Headache; Tension-Type Headache
• Other Study ID Numbers: F-24075902

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No