MigraineNCT02269501
Exercise in Migraine and Co-existing Tension-type Headache and Neck Pain
A study testing Exercise treatment in people with Migraine and Tension-type Headache, run by Danish Headache Center at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine, Tension-type Headache, Neck Pain
- What is being tested?
- Exercise treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2012to 23 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Migraine
- Tension-type headache
- Neck pain
Who cannot join
- Whiplash injury or other significant neck trauma
- Nerve root compression
- Post traumatic headache
- Medication overuse headache
- Cluster headache
- Trigeminal neuralgia
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Danish Headache Center, Department of Neurology
Glostrup Municipality, 2600
About this study
Official title: 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.
Read the 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.
- Conditions
- Migraine, Tension-type Headache, Neck Pain
- Being tested
- Exercise treatment
- Medical subject headings
- Migraine Disorders, Tension-Type Headache, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise treatmentOther
| Study group | Role | What they receive |
|---|---|---|
| Exercise treatment | Experimental | Exercise treatment Receives: Other: Exercise treatment |
| No treatment | No intervention | No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At baseline and after three, six and 12 months follow-up
Secondary outcomes (3)
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).
Measured: 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
Measured: At baseline and after three and six months follow-up
Changes in aerobic fitness
Åstrands submaximal bicycle test
Measured: At baseline and after three and six months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startNov 2012
- Primary completionSep 2016
- Study completion23 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lotte Skytte Krøll, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269501
- Sponsor's protocol ID
- H-1-2011-090
- Status last verified
- Feb 2019
- First submitted
- 10 Jul 2014
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Specific Exercise Program on Patients Suffering From Migraine and Co-existing Tension-type Headache and Neck Pain
- ClinicalTrials.gov ID
- NCT02269501
- Acronym / sponsor ID
- H-1-2011-090
- Conditions
- Migraine, Tension-type Headache, Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Sep 2016 (actual)
- Study completion
- 23 May 2018 (actual)
- First posted
- 21 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise treatment | Experimental | Other: Exercise treatmentExercise treatment |
| No treatment | No intervention | –No treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Migraine
- Tension-type headache
- Neck pain
Key exclusion criteria (12 listed)
- Whiplash injury or other significant neck trauma
- Nerve root compression
- Post traumatic headache
- Medication overuse headache
- Cluster headache
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise treatment | Other | Exercise treatment |
Primary outcome
Changes in pain
Time frame: At baseline and after three, six and 12 months follow-up
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
3 secondary outcomes
Changes in headache and neck pain impact
Time frame: At baseline and after three, six and 12 months follow-up
Changes in quatitative sensory testing
Time frame: At baseline and after three and six months follow-up
Changes in aerobic fitness
Time frame: At baseline and after three and six months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise treatment in people with Migraine and Tension-type Headache, run by Danish Headache Center at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in pain (time frame: At baseline and after three, six and 12 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019.