Body Versus Machine: Deep Breathing Versus Vagus Stimulation for the Treatment of Fibromyalgia
NCT03180554
Chronic Pain, Chronic Widespread Pain
Oslo, Norway
View Trial DetailsNCT Number: NCT02872129
A 12-year follow-up of 166 women with fibromyalgia (FM) or chronic widespread pain (CWP) in western Sweden.
The 166 women participated in a Randomised Controlled Trial called GAU in 2004-2005, aiming to investigate the effect of pool exercise and patient education.
The primary aim of the present study is to examine the change of symptoms after 11-12 years in 166 women with FM or CWP and also investigate predictors of change of symptoms and work ability.
The 166 women will be asked to participate in the present follow-up study. The follow-up examination comprises a standardised interview of symptoms and demographic variables, a battery of self-administered questionnaires and tests of physical function.
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Observational
Närhälsan, Region Västra Götaland, Alingsås, Sweden
A 12-year follow-up of 166 women with fibromyalgia (FM) or chronic widespread pain (CWP).
The 166 women participated in a Randomised Controlled Trial called GAU 2004-2005 in three cities in western Sweden; Göteborg, Alingsås and Uddevalla. The RCT aimed to investigate the effect of pool exercise and patient education.
The primary aim of the present study is to examine the change of symptoms after 11-12 years in 166 women with FM or CWP and also investigate predictors of change of symptoms and work ability.
The 166 women will be contacted by mail and telephone, and asked to participate in the present follow-up study.
The follow-up examination comprises a standardised interview of symptoms and demographic variables, a battery of self-administered questionnaires and tests of physical function.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
of the present study GAU-U:
Exclusion criteria
for GAU was serious physical or psychological disease)
Exclusion criteria
of the present study GAU-U:
Time frame: 2016 (to be compared with previous examination performed in 2004/2005)
pain intensity assessed with the Fibromyalgia Impact questionnaire subscale for pain
Time frame: 2016 (to be compared with previous examination performed in 2004/2005)
Distribution of pain
Time frame: 2016 (to be compared with previous examination performed in 2004/2005)
fatigue assessed with the Multidimensional fatigue inventory (MFI-20)
Time frame: 2016 (to be compared with previous examination performed in 2004/2005)
fatigue assessed with the Fibromyalgia Impact Questionnaire subscale for global fatigue
Time frame: 2016 (to be compared with previous examination performed in 2004/2005)
workability assessed as percentage of full time in work
Time frame: 2016 (to be compared with previous examination performed in 2004/2005)
Walking capacity assessed with 6 min walk test
Time frame: 2016 (to be compared with previous examination performed in 2004/2005)
physical function in lower limbs assessed with chair-test
Time frame: 2016 (to be compared with previous examination performed in 2004/2005)
Hand grip force assessed with the Grippit
Time frame: 2016 (to be compared with previous examination performed in 2004/2005)
physical activity in leisure time assessed with the Leisure Time Physical Activity Instrument
Time frame: 2016 (to be compared with previous examination performed in 2004/2005)
depression and anxiety assessed with the Hospital Anxiety and Depression Scale
Time frame: 2016 (to be compared with previous examination performed in 2004/2005)
Health related quality of life assessed with the Short-Form 36
Time frame: 2016 (to be compared with previous examination performed in 2004/2005)
quantity and quality of sleep
Time frame: 2016 (to be compared with previous examination performed in 2004/2005)
alcohol consumption assessed with the Balogh questionnaire
Göteborg University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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