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Enrolling by Invitation

NCT Number: NCT06859463

Muscle Function and Tenderness Differences in Headache Patients

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Danish Headache Center

Copenhagen, Region H, 2600, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Muscle function

Device

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.

Primary outcomes

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

    Time frame: 1 year

    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.

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Mar 5, 2025
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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