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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
Danish Headache Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
July 10, 2014
Last Updated
February 7, 2019
Sponsor
Danish Headache Center
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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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