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

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02269501
• Other study ID #: H-1-2011-090
• Status: Completed
• Phase: N/A
• Start date: November 2012
• Est. completion date: May 23, 2018

Study information

• Verified date: February 2019
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 23, 2018
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Migraine
• Migraine Disorders
• Neck Pain
• Tension-Type Headache

Intervention

Other:
• Exercise treatment

Locations

Country	Name	City	State
Denmark	Danish Headache Center, Department of Neurology	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Changes in aerobic fitness	Åstrands submaximal bicycle test	At baseline and after three and six months follow-up