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Enrolling by invitationNCT06859463Updated Mar 10, 2025

Muscle Function and Tenderness Differences in Headache Patients

An observational study in Migraine, Tension Headache and Posttraumatic Headache, sponsored by Danish Headache Center. Enrolling by invitation at 1 site in Denmark. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-03-10.

Sponsored by Danish Headache Center · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 2 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
90
Ages
18 Years to 65 Years
Sex
All
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Study 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.

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Conditions studied

  • Migraine
  • Tension Headache
  • Posttraumatic Headache
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In context

Migraine Disorders

1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.

This study's planned enrollment of 90 is below the median of 137 across 331 observational studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Danish Headache Center is the lead sponsor of 129 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
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

Eligibility criteria

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:

-

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Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
90 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • 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

  • DeviceMuscle 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.

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What researchers measure

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.

    Time frame: 1 year

07

Study locations

1 site
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06859463
Responsible party
Bjarne Kjeldgaard Madsen (physiotherapist ph.d, Danish Headache Center) — Principal investigator
First posted
Mar 5, 2025
Start date
Feb 28, 2025
Primary completion
Sep 1, 2025 (estimated)
Completion
Mar 1, 2026 (estimated)
Last update
Mar 10, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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