MigraineNCT06859463
Muscle Function and Tenderness Differences in Headache Patients
An observational study of Migraine and Tension Headache, run by Danish Headache Center at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine, Tension Headache, Posttraumatic Headache
- What is being tested?
- Muscle function
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 90 participants
- Where
- 1 siteDenmark
- Study dates
- 28 Feb 2025to 1 Mar 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- Pregnancy.
- Significant psychiatric comorbidities (e.g., severe depression).
- Medication-overuse headache.
- Severe osteoarthritis in the neck or shoulder, or cervical disc herniation.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Migraine, Tension Headache, Posttraumatic Headache
- Being tested
- Muscle function
- Medical subject headings
- Migraine Disorders, Tension-Type Headache, Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Muscle function | |
| Posttraumatic headache patients Posttraumatic headache patients with at least 10 days per month of h | Not described Receives: Device: Muscle function | |
| Tensional-type headache patients Tensional-type headache patients with at least 10 days per month of | Not described Receives: Device: Muscle function |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start28 Feb 2025
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bjarne Kjeldgaard Madsen, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859463
- Sponsor's protocol ID
- F-24075902
- Status last verified
- Feb 2025
- First submitted
- 28 Feb 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Function and Tenderness in Migraine, Tension-Type Headache, and Posttraumatic Headache Patients: a Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT06859463
- Acronym / sponsor ID
- F-24075902
- Conditions
- Migraine, Tension Headache, Posttraumatic Headache
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Migraine patients Migraine patients with at least 10 days per month of headache | – | Device: Muscle functionTensional-type headache patients Tensional-type headache patients with at least 10 days per month of headache. |
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- Pregnancy.
- Significant psychiatric comorbidities (e.g., severe depression).
- Medication-overuse headache.
- Severe osteoarthritis in the neck or shoulder, or cervical disc herniation.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle functionFunctional 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. | Device | Migraine patients Migraine patients with at least 10 days per month of headache, Posttraumatic headache patients Posttraumatic headache patients with at least 10 days per month of h, Tensional-type headache patients Tensional-type headache patients with at least 10 days per month of |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine and Tension Headache, run by Danish Headache Center at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure: 1.Rate of Force Development (RFD) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.