Clinical trial NCT01664585: Exercise Training With Physically Active Lifestyle to Reduce Headache and Quality of Life
Official title: EXERCISE TRAINING WITH PHYSICALLY ACTIVE LIFESTYLE TO REDUCE HEADACHE AND INCREASE QUALITY OF LIFE. A Randomised Controlled Trial of the Effectiveness and Cost-effectiveness of Exercise Training and Physical Activity on Chronic Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache
Physical Activity
Quality of Life
Keywords: headache
women
exercise
fear avoidance
physical activity
Lead sponsor: UKK Institute
Sponsor class: OTHER
Collaborators: name: Jyväskylä Central Hospital
name: University of Jyvaskyla
First posted: 2012-08-14
Enrollment: 116
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this intervention study is to examine whether tailored exercise therapy training is effective and cost-effective to decrease headache frequency and intensity, reduce medication used for chronic headache and patients´ absence from work, improve their neck muscle force, cervical spine mobility, functional ability and quality of life, and increase general physical activity in chronic headache women at regular work during a 6-month intervention.

The intervention itself with pilot-tested upper-neck specific exercise regimen aims that patients would independently commit to train and exercise to reduce their headache, and thus increase their quality of life. In addition, reduced pain and frequency of headache may increase the objectively measured daily physical activity of chronic headache patients.

Detailed description: Tension-type,migraine and cervicogenic headache are the most common reasons for visits to a primary care physician among working women. Headache has major economic impact due to patients' absence from work, and pharmacy claims. Neck symptoms induce three percent of all visits to a primary care physician and 1 % of all costs in health care, and moreover, institutionalizing increase costs of treatment. Active treatment may offer cost-effective option for outpatients. In addition, there is no data showing how much headache/neck pain restricts participation in physical activity (PA) or other activities in society.

The purpose of this study is to investigate whether specific therapeutic exercises reduce cervicogenic headache cost-effectively, and simultaneously improve neck function and quality of life. The other aim is to evaluate the effect of exercises on daily PA in women with chronic headache.

The following hypotheses will be tested:

1. Specific therapeutic exercises based on individual training reduce cost-effectively cervicogenic headache and improve neck function, and quality of life on women at regular work during a 6-month intervention
2. The intervention increases general physical activity of women with cervicogenic headache
3. The intervention assists them to manage the headache by way of exercising during the follow-up.
4. Physical activity of women with chronic cervicogenic headache is lower than average in Finnish population.

The HEADEX intervention study is a randomized controlled trial. Volunteers, women at regular work and having ongoing status with chronic migraine and/or cervicogenic headache will be recruited using newspaper advertising, from the register of Finnish Migraine Society and occupational health care services in Helsinki, Tampere and Jyvaskyla. The study sample is restricted to women, as the headache is much more common in women. After recruitment, the eligibility of patients to participate is screened. In total, the aim is to obtain 120 women to participate. The two subsequent baseline assessments and follow-up of headaches with the diary between two months before the beginning of the intervention enable ensuring intensity and type of the headache and that it is chronic. Randomisation is centralised but the intervention will be accomplished and clustered in three study centres. Sample size has been estimated for the primary outcomes. The number of participant will be 60 women in treatment and 60 control group.

The 6 months exercise intervention consists of 6 supervised progressive exercise training sessions and home training program, and the participants are instructed to increase their PA. The main emphasis of the exercise program is to improve and relearn postural and movement control of neck, and later on strengthen the postural muscles. The exercise intervention consists of six supervised progressive exercise training sessions to teach rehabilitative training technique with similar home training program. Before the intervention, information on work ergonomics will be enquired and if needed, changes will be recommended. The control group will receive Transcutaneous Nervous Stimulation treatment (6 times) as a placebo treatment (intensity 0), and recommendation to maintain their PA at previous level. The follow-up is identical for both groups, and information on exercise frequency is collected up to 24 months follow-up.

Eligibility criteria: Inclusion Criteria:

* women aged 18 to 60 and currently at work and aim to continue at same work at least two years
* intensity of headache on Visual Analog Scale (VAS) has been equal or greater than 45 mm (scale 0-100) during last two months
* Headache Impact Test TM \[HIT-6 Scoring Interpretation Finland (Finnish) Version 1.1\] 58/78 points

Exclusion Criteria:

* severe degenerative changes at cervical vertebra or discus (including discus prolapse)
* whiplash injury or injury, which is contraindication for exercise and active lifestyle
* treated with manual therapy or physiotherapy within a previous month
* changed medication known to affect headaches during a previous month
* changed bifocals during previous month
* athletic trainees (3 or more times per week)
* alcoholic and/or drug addicts/ AUDIT The Alcohol Use Disorders Identification Test, Finnish version
* mental depression

Primary outcomes:
measure: Change from baseline in headache intensity at 6 months
timeFrame: At baseline and follow-up after 6-months intervention
Secondary outcomes:
measure: Amount and intensity of weekly physical activity
timeFrame: At baseline, after 6-mo, 12-mo,and 24-mo
measure: Health economics
timeFrame: At baseline, after 6-mo, 12-mo, and 24-mo
measure: Quality of Life (QoL)
timeFrame: At baseline, after 6-mo, 12-mo, and 24-mo
measure: Fear avoidance beliefs
timeFrame: At baseline, after 6-mo, 12-mo, and 24-mo
measure: Frequency of headache
timeFrame: At baseline, after 6-mo, 12-mo, and 24-mo
measure: Disability
timeFrame: At baseline, after 6-mo, 12-mo, and 24-mo
Other outcomes:
Locations:
city: Jyväskylä
country: Finland
facility: University of Jyväskylä
city: Jyväskylä
country: Finland
facility: Jyväskylä Central Hospital, Department of Physical and Rehabilitation Medicine
city: Tampere
country: Finland
facility: UKK Institute
Study officials:
affiliation: UKK Institute
name: Marjo B Rinne, PhD
role: STUDY_DIRECTOR
affiliation: University of Jyvaskyla
name: Riku P Nikander, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Jyvaskyla
name: Arja H Häkkinen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jyväskylä Central Hospital
name: Jari J Ylinen, MD, DO, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rehabilitation, South Karelia Social and Health Care District (Eksote)
name: Katriina Kukkonen-Harjula, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UKK Institute
name: Kari Tokola, MSci
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki Metropolia University of Applied Sciences
name: Sanna Garam, MSci
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Ylinen J, Kautiainen H, Wiren K, Hakkinen A. Stretching exercises vs manual therapy in treatment of chronic neck pain: a randomized, controlled cross-over trial. J Rehabil Med. 2007 Mar;39(2):126-32. doi: 10.2340/16501977-0015.
citation: Waddell G, Newton M, Henderson I, Somerville D, Main CJ. A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain. 1993 Feb;52(2):157-168. doi: 10.1016/0304-3959(93)90127-B.
citation: British Association for the Study of Headache Guidelines for All Healthcare Professionals in the Diagnosis and Management of Migraine, Tension-Type, Cluster and Medication-Overuse Headache Writing Committee: EA MacGregor, TJ Steiner, PTG Davies 3rd edition (1st revision). 2010.