Exercise in Migraine and Co-existing Tension-type Headache and Neck Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the effect of a physical exercise program on patients suffering from migraine and co-existing tension-type headache and neck pain. The investigators hypothesized that migraine patients are ofte physically inactive because of their headache and that they will benefit from a specific exercise program.

Detailed Description
-----------------
Migraine and tension-type headache are among the most common neurological diseases and are causing reduced quality of life, private and socio-economic consequences in terms of medical consumption and work-related absenteeism. The clinical experience shows that physical activity, like cycling and brisk walking, can prevent migraine attacks, but the evidence of the efficacy is sparse. The primary aim of the study is to investigate the acute and the long term effect of exercise on patients suffering from migraine and co-existing tension-type headache and neck pain. The project will be the first of its kind that explores the effect of an exercise program on patients who both suffer from migraine, tension-type headache and neck pain. We expect that the participants from the exercise program will achieve a reduced pain impact on everyday life, an improved fitness and quality of life, and a decrease of absence days and medication use.

Official Title
-----------------
The Effect of a Specific Exercise Program on Patients Suffering From Migraine and Co-existing Tension-type Headache and Neck Pain

Conditions
-----------------
Migraine, Tension-type Headache, Neck Pain

Intervention / Treatment
-----------------
* Other: Exercise treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Migraine Tension-type headache Neck pain Exclusion Criteria: Whiplash injury or other significant neck trauma Nerve root compression Post traumatic headache Medication overuse headache Cluster headache Trigeminal neuralgia Pregnancy and breast feeding Severe physical and psychological illnesses Alcohol and or drug abuse Current insurance claim owing to headache Persons not able to speak or understand Danish Persons deemed not to implement the program because of musculoskeletal pain or physical limitations

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise treatment<br>Exercise treatment | Other: Exercise treatment<br> <br> |
| No Intervention: No treatment<br>No treatment | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in pain | Pain intensity, pain frequency and pain duration for migraine, tension-type headache and neck pain based on four-weeks headache and neck pain diaries prior inclusion; and diaries filled out each day for three months during intervention and again four weeks prior to six months follow-up and again four weeks prior to 12 months follow-up | At baseline and after three, six and 12 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in headache and neck pain impact | Headache and neck pain impact measured by the following questionnaires: Impact of Migraine, Tension-Type Headache and Neck Pain (a newly developed questionnaire), International Physical Activity Questionnaire (IPAQ short form), Migraine Specific Quality of Life Questionnaire (MSQ v. 2.1), Psychological well-being index (WHO-5), Major Depression Inventory (MDI) and Neck Disability Index (NDI). | At baseline and after three, six and 12 months follow-up | 
| Changes in quatitative sensory testing | Quantitative sensory tests are measured by: Total tenderness score, local tenderness score, pressure pain threshold and suprathreshold pain sensitivity | At baseline and after three and six months follow-up | 
| Changes in aerobic fitness | Åstrands submaximal bicycle test | At baseline and after three and six months follow-up |