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
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 10, 2014
CompletedFirst Posted
Study publicly available on registry
October 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 23, 2018
CompletedFebruary 8, 2019
February 1, 2019
3.8 years
July 10, 2014
February 7, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Changes in headache and neck pain impact
At baseline and after three, six and 12 months follow-up
Changes in quatitative sensory testing
At baseline and after three and six months follow-up
Changes in aerobic fitness
At baseline and after three and six months follow-up
Study Arms (2)
Exercise treatment
EXPERIMENTALExercise treatment
No treatment
NO INTERVENTIONNo treatment
Interventions
Eligibility Criteria
You may qualify if:
- Migraine
- Tension-type headache
- Neck pain
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Danish Headache Center, Department of Neurology
Glostrup Municipality, 2600, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PT, MPH, PhD student
Study Record Dates
First Submitted
July 10, 2014
First Posted
October 21, 2014
Study Start
November 1, 2012
Primary Completion
September 1, 2016
Study Completion
May 23, 2018
Last Updated
February 8, 2019
Record last verified: 2019-02