Muscle Function and Tenderness Differences in Headache Patients

NCT ID: NCT06859463

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2026-03-01

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.

Conditions

Migraine; Tension Headache; Posttraumatic Headache

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

Muscle function

Intervention Type: 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.

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

Muscle function

Intervention Type: 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.

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

Muscle function

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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.

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Danish Headache Center

OTHER

Sponsor Role: lead

Responsible Party

Bjarne Kjeldgaard Madsen

physiotherapist ph.d

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Danish Headache Center

Copenhagen, Region H, Denmark

Countries

Denmark

Other Identifiers

F-24075902

Identifier Type: -

Identifier Source: org_study_id