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

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ClinicalTrials.gov Identifier: NCT02269501
Recruitment Status : Completed
First Posted : October 21, 2014
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Lotte Skytte Krøll, Danish Headache Center

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.

Condition or disease Intervention/treatment Phase
Migraine Tension-type Headache Neck Pain Other: Exercise treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of a Specific Exercise Program on Patients Suffering From Migraine and Co-existing Tension-type Headache and Neck Pain
Study Start Date : November 2012
Actual Primary Completion Date : September 2016
Actual Study Completion Date : May 23, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise treatment
Exercise treatment
Other: Exercise treatment
No Intervention: No treatment
No treatment



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Changes in headache and neck pain impact [ Time Frame: At baseline and after three, six and 12 months follow-up ]
    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).

  2. Changes in quatitative sensory testing [ Time Frame: At baseline and after three and six months follow-up ]
    Quantitative sensory tests are measured by: Total tenderness score, local tenderness score, pressure pain threshold and suprathreshold pain sensitivity

  3. Changes in aerobic fitness [ Time Frame: At baseline and after three and six months follow-up ]
    Åstrands submaximal bicycle test



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02269501


Locations
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Denmark
Danish Headache Center, Department of Neurology
Glostrup, Denmark, 2600
Sponsors and Collaborators
Danish Headache Center

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Responsible Party: Lotte Skytte Krøll, PT, MPH, PhD student, Danish Headache Center
ClinicalTrials.gov Identifier: NCT02269501    
Other Study ID Numbers: H-1-2011-090
First Posted: October 21, 2014    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Migraine Disorders
Tension-Type Headache
Headache
Neck Pain
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms