Clinical trial NCT06112587: Muscle Function and Strength Training of the Neck and Shoulder in Migraine and Tension-type Headache Patients. A Singel Arm Open Label Trial
Official title: Muscle Function and Strength Training of the Neck and Shoulder in Migraine and Tension-type Headache Patients.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Migraine
Tension-Type Headache
Neck Pain
Keywords: migraine
tension-type headache
strength training
neck pain
exercise
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A Single-Arm Open-Label Trial
Primary purpose: TREATMENT

Brief summary: A Single-Arm Open-Label Trial was performed at the Danish Headache Center (DHC), Department of Neurology, Rigshospitalet - Glostrup as part of the clinic.

Purpose:

To examine the effects of supervised group strength training and posture correction on headache frequency and muscle function around the neck and shoulders in patients with migraine and tension-type headaches.

Hypothesis:

Strength training of the neck and shoulders results in improved muscle function, which leads to a reduction in headache.


Eligibility criteria: Inclusion Criteria:

* Migraine patients with stable CGRP or botox.
* Tension type headache with no more than 5 migraine days/month.
* At least four days/months of headache at the moment of recruitment.

Exclusion Criteria:

* Pregnancy
* Post-traumatic headache, or headache that is likely to be associated with trauma.
* Significant psychiatric comorbidities, such as severe depression
* Medication Overuse Headaches.
* Severe arthrosis in the neck, shoulder, or disc herniation in the neck.

Primary outcomes:
measure: headache frequency
timeFrame: two weeks prior to intervention, last two weeks of intervention
Secondary outcomes:
measure: neck pain maximal intensity
timeFrame: two weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after intervention
measure: neck pain average intensity
timeFrame: two weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after intervention
measure: neck pain frequency
timeFrame: two weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after intervention
measure: headache duration
timeFrame: two weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after intervention
measure: medication intake
timeFrame: two weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after intervention
measure: Functional level
timeFrame: Before intervention, after intervention and at 1 month follow up
measure: Headache average Intensity
timeFrame: two weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after intervention
measure: Headache maximal Intensity
timeFrame: two weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after intervention
measure: headache frequency
timeFrame: weeks 4 and 5 after intervention
Other outcomes:
measure: Maximal Voluntary Contraction of the Neck extension
timeFrame: Before intervention, after intervention and at 1 month follow up
measure: Maximal Voluntary Contraction of the Neck flexion
timeFrame: Before intervention, after intervention and at 1 month follow up
measure: Maximal Voluntary Contraction of the Shoulder elevation
timeFrame: Before intervention, after intervention and at 1 month follow up
measure: Moment arm for neck flexion and extension
timeFrame: Before intervention
measure: Moment arm for shoulder elevation
timeFrame: Before intervention
measure: Moment arm for neck flexion
timeFrame: Before intervention, after intervention and at 1 month follow up
measure: Moment arm of the neck extension
timeFrame: Before intervention, after intervention and at 1 month follow up
measure: Moment arm fof the shoulder elevation
timeFrame: Before intervention, after intervention and at 1 month follow up
measure: Extension-Flexion ratio
timeFrame: Before intervention, after intervention and at 1 month follow up
measure: Rate of force development of the shoulder elevation
timeFrame: Before intervention, after intervention and at 1 month follow up
measure: Early rate of force development of the shoulder elevation
timeFrame: Before intervention, after intervention and at 1 month follow up
measure: Muscle tenderness
timeFrame: Before intervention, after intervention and at 1 month follow up
measure: Muscle tenderness of the face
timeFrame: Before intervention, after intervention and at 1 month follow up
measure: Muscle tenderness of the neck
timeFrame: Before intervention, after intervention and at 1 month follow up
measure: Craniocervical flexion score
timeFrame: Before intervention, after intervention and at 1 month follow up
measure: Exercise sessions completed
timeFrame: During the intervention
measure: Percieved intensity
timeFrame: During the intervention
measure: Intensity coherence
timeFrame: post-intervention
measure: Adherence of the programm
timeFrame: post-intervention
measure: Adherence to exercise
timeFrame: Week 1 to 5 after intervention
measure: Compliance of the programm
timeFrame: post-intervention
Locations:
city: Glostrup
country: Denmark
facility: Danish Headache Center Rigshospitalet - Glostrup
Study officials:
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