Exercise in Migraine and Co-existing Tension-type Headache and Neck Pain
Primary Purpose
Migraine, Tension-type Headache, Neck Pain
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Exercise treatment
Sponsored by
About this trial
This is an interventional treatment trial for Migraine
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
Sites / Locations
- Danish Headache Center, Department of Neurology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercise treatment
No treatment
Arm Description
Exercise treatment
No treatment
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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).
Changes in quatitative sensory testing
Quantitative sensory tests are measured by: Total tenderness score, local tenderness score, pressure pain threshold and suprathreshold pain sensitivity
Changes in aerobic fitness
Åstrands submaximal bicycle test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02269501
Brief Title
Exercise in Migraine and Co-existing Tension-type Headache and Neck Pain
Official Title
The Effect of a Specific Exercise Program on Patients Suffering From Migraine and Co-existing Tension-type Headache and Neck Pain
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
May 23, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Headache Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Tension-type Headache, Neck Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise treatment
Arm Type
Experimental
Arm Description
Exercise treatment
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
No treatment
Intervention Type
Other
Intervention Name(s)
Exercise treatment
Primary Outcome Measure Information:
Title
Changes in pain
Description
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
Time Frame
At baseline and after three, six and 12 months follow-up
Secondary Outcome Measure Information:
Title
Changes in headache and neck pain impact
Description
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).
Time Frame
At baseline and after three, six and 12 months follow-up
Title
Changes in quatitative sensory testing
Description
Quantitative sensory tests are measured by: Total tenderness score, local tenderness score, pressure pain threshold and suprathreshold pain sensitivity
Time Frame
At baseline and after three and six months follow-up
Title
Changes in aerobic fitness
Description
Åstrands submaximal bicycle test
Time Frame
At baseline and after three and six months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Danish Headache Center, Department of Neurology
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
12. IPD Sharing Statement
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Exercise in Migraine and Co-existing Tension-type Headache and Neck Pain
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