Muscle Function and Strength Training of the Neck and Shoulder in Migraine and Tension-type Headache Patients. A Singel Arm Open Label Trial

Study Overview
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Brief Summary
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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.

Official Title
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Muscle Function and Strength Training of the Neck and Shoulder in Migraine and Tension-type Headache Patients.

Conditions
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Migraine, Tension-Type Headache, Neck Pain

Intervention / Treatment
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* Behavioral: strength training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: A Single-Arm Open-Label Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Migraine and tension-type headache patients<br>Patients diagnosed by a neurologist following the 3rd edition of the International Classification of Headaches Disorders (ICHD-III) | Behavioral: strength training<br>* A targeted 8-week strength-training course was offered as an intervention in combination with ergonomics and posture corrections and recommendations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| headache frequency | number of days with headache | two weeks prior to intervention, last two weeks of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neck pain maximal intensity | maximal neck pain intensity percieved by patient in a 0-10 NRPS | two weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after intervention | 
| neck pain average intensity | average neck pain intensity percieved by patient in a 0-10 NRPS | two weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after intervention | 
| neck pain frequency | number of days with neck pain | two weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after intervention | 
| headache duration | hours with headache | two weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after intervention | 
| medication intake | number of days with medication for pain taked | two weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after intervention | 
| Functional level | Self-reported limitated activities due to headache in a 0-10 scale thourgh the Patient-Specific Functional Scale | Before intervention, after intervention and at 1 month follow up | 
| Headache average Intensity | average headache intensity percieved by patient in a 0-10 NRPS | two weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after intervention | 
| Headache maximal Intensity | maximal headache intensity percieved by patient in a 0-10 NRPS | two weeks prior to intervention, last two weeks of intervention, and weeks 4 and 5 after intervention | 
| headache frequency | number of days with headache | weeks 4 and 5 after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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migraine, tension-type headache, strength training, neck pain, exercise