Exercise Training With Physically Active Lifestyle to Reduce Headache and Quality of Life
NCT ID: NCT01664585
Last Updated: 2017-05-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
116 participants
INTERVENTIONAL
2012-09-17
2015-07-03
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Training group
The rationale and means for the exercise program are to
1. Motivate and teach participants for postural and motor control and strengthening exercises
2. Monitor and motivate to continue exercise training, and to increase their physical activity
Training is organised six times as a 60-min session during six months: two individually supervised sessions, and four following training sessions will be accomplished in groups of 10 participants guided by an experienced physical therapist. Three weekly similar home training sessions are recommended for participants. Information on amount of exercise sessions per week and repetitions of each exercise will be collected via exercise diary. To perform home training, a DVD and/or booklet will be provided to participants in the training group.
Training group
The 60-minute training sessions include a few mobilization techniques for upper neck. In detail, three different exercises concentrated on postural and motor control will be taught during the first two training sessions. Progressively, two additional exercise movements aiming at postural and motor control will be taught in the next session. After eight weeks, two muscle strength exercises utilising therapeutic rubber band will be included into the program. The aim of the rubber band exercises is eventually to achieve the load of 80% of maximal voluntary contraction. The participants in the training group are also instructed to increase their amount of physical activity progressively according to the current physical activity recommendations.
Control
The control group will receive six sessions of Transcutaneous Nervous Stimulation treatment (TNS) as a placebo treatment (0), and the participants in this group are recommended and encouraged to maintain their previous normal level of physical activity and exercise habits throughout the study without any supervision or home training programs.
Control
The control group will receive six sessions of Transcutaneous Nervous Stimulation treatment (TNS) as a placebo treatment (0) and the participants in control group are recommended and encouraged to maintain their previous normal level of physical activity and exercise habits throughout the study without any supervision or home training programs.
Interventions
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Training group
The 60-minute training sessions include a few mobilization techniques for upper neck. In detail, three different exercises concentrated on postural and motor control will be taught during the first two training sessions. Progressively, two additional exercise movements aiming at postural and motor control will be taught in the next session. After eight weeks, two muscle strength exercises utilising therapeutic rubber band will be included into the program. The aim of the rubber band exercises is eventually to achieve the load of 80% of maximal voluntary contraction. The participants in the training group are also instructed to increase their amount of physical activity progressively according to the current physical activity recommendations.
Control
The control group will receive six sessions of Transcutaneous Nervous Stimulation treatment (TNS) as a placebo treatment (0) and the participants in control group are recommended and encouraged to maintain their previous normal level of physical activity and exercise habits throughout the study without any supervision or home training programs.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
FEMALE
No
Sponsors
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Jyväskylä Central Hospital
OTHER
University of Jyvaskyla
OTHER
UKK Institute
OTHER
Responsible Party
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Marjo Rinne, PhD
Researcher
Principal Investigators
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Marjo B Rinne, PhD
Role: STUDY_DIRECTOR
UKK Institute
Riku P Nikander, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Jyvaskyla
Arja H Häkkinen, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Jyvaskyla
Jari J Ylinen, MD, DO, PhD
Role: PRINCIPAL_INVESTIGATOR
Jyväskylä Central Hospital
Katriina Kukkonen-Harjula, MD
Role: PRINCIPAL_INVESTIGATOR
Rehabilitation, South Karelia Social and Health Care District (Eksote)
Kari Tokola, MSci
Role: PRINCIPAL_INVESTIGATOR
UKK Institute
Sanna Garam, MSci
Role: PRINCIPAL_INVESTIGATOR
Helsinki Metropolia University of Applied Sciences
Locations
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University of Jyväskylä
Jyväskylä, , Finland
Jyväskylä Central Hospital, Department of Physical and Rehabilitation Medicine
Jyväskylä, , Finland
UKK Institute
Tampere, , Finland
Countries
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References
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De Hertogh W, Vaes P, Devroey D, Louis P, Carpay H, Truijen S, Duquet W, Oostendorp R. Preliminary results, methodological considerations and recruitment difficulties of a randomised clinical trial comparing two treatment regimens for patients with headache and neck pain. BMC Musculoskelet Disord. 2009 Sep 23;10:115. doi: 10.1186/1471-2474-10-115.
Fricton J, Velly A, Ouyang W, Look JO. Does exercise therapy improve headache? a systematic review with meta-analysis. Curr Pain Headache Rep. 2009 Dec;13(6):413-9. doi: 10.1007/s11916-009-0081-2. No abstract available.
Fuller G, Kaye C. Headaches. BMJ. 2007 Feb 3;334(7587):254-6. doi: 10.1136/bmj.39090.652847.DE. No abstract available.
Gross A, Miller J, D'Sylva J, Burnie SJ, Goldsmith CH, Graham N, Haines T, Bronfort G, Hoving JL. Manipulation or mobilisation for neck pain. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD004249. doi: 10.1002/14651858.CD004249.pub3.
Jull G, Trott P, Potter H, Zito G, Niere K, Shirley D, Emberson J, Marschner I, Richardson C. A randomized controlled trial of exercise and manipulative therapy for cervicogenic headache. Spine (Phila Pa 1976). 2002 Sep 1;27(17):1835-43; discussion 1843. doi: 10.1097/00007632-200209010-00004.
Ylinen J, Takala EP, Nykanen M, Hakkinen A, Malkia E, Pohjolainen T, Karppi SL, Kautiainen H, Airaksinen O. Active neck muscle training in the treatment of chronic neck pain in women: a randomized controlled trial. JAMA. 2003 May 21;289(19):2509-16. doi: 10.1001/jama.289.19.2509.
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.
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.
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.
Other Identifiers
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UKK Institute/173
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
R12006
Identifier Type: -
Identifier Source: org_study_id
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