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

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

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.

Study Overview

• Status: Completed
• Conditions: Migraine; Neck Pain; Tension-type Headache
• Intervention / Treatment: Other: Exercise treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Glostrup, Denmark, 2600
    • Danish Headache Center, Department of Neurology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No treatment
Experimental: Exercise treatment	Other: Exercise 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

Collaborators and Investigators

• Sponsor: Danish Headache Center

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): May 23, 2018

Study Registration Dates

• First Submitted: July 10, 2014
• First Submitted That Met QC Criteria: October 20, 2014
• First Posted (Estimate): October 21, 2014

Study Record Updates

• Last Update Posted (Actual): February 8, 2019
• Last Update Submitted That Met QC Criteria: February 7, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Neck Pain; Migraine Disorders; Headache; Tension-Type Headache
• Other Study ID Numbers: H-1-2011-090