Clinical trial NCT01557062: Passive Body Heating, Sleep and Fibromyalgia
Official title: Passive Body Heating Improves The Sleep Pattern In Women Patients Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Hydrotherapy
Sleep
Pain
Body Temperature
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2012-03-19
Enrollment: 25
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Objectives: To assess the effect of passive body heating on the sleep pattern of patients with fibromyalgia.

Methods: Six menopausal women diagnosed with fibromyalgia according to criteria determined by the American College of Rheumatology were included. All women underwent passive immersion in a warm bath at 36±1 °C, for 15 sessions of 30 minutes each over 3 weeks. Their sleep pattern was assessed by polysomnography at the following conditions: pre-intervention (baseline), on the first day of intervention (acute), on the last day of intervention (chronic) and 3 weeks after the end of interventions (follow-up). Core body temperature was evaluated by a thermistor pill at the above-mentioned conditions. The impact on fibromyalgia was assessed through of a specific questionnaire called fibromyalgia impact questionnaire.

Detailed description: Patients were attended at the Psychobiology and Exercise Studies Centre 5 times a week for 3 weeks between 6:00pm and 8:00pm for passive body-heating interventions for 30 min each session. The patients were accompanied by a researcher to a therapeutic water bath (Barritz Hydrotherapy Appliance, Germany) and were comfortably positioned in a supine position with their necks supported by an inflatable floating pillow to keep the body relaxed and safe during the intervention. The room temperature at the laboratory was maintained at 23±1 ºC, and the water temperature was 36±1ºC.

Eligibility criteria: Inclusion Criteria:

* Fibromyalgia diagnostic
* Women
* Post menopausal
* Sedentary

Exclusion Criteria:

* Other diagnosis of chronic illnesses

Primary outcomes:
measure: Sleep Pattern
timeFrame: 7 weeks. Was measured the sleep parameters from: Baseline to acute's time point (at the first day of intervention); Acute to chronic's time point (after 15 sections); Chronic's to follow-up time point (at 15 days after end point of interventions).
Secondary outcomes:
measure: Impact of Fibromyalgia Disease
timeFrame: 7 weeks- The measurements occurred at the following time points: baseline, chronic and follow-up.
measure: Changes in Core Body Temperature (CBT)
timeFrame: 7 weeks. Was measured the CBT from: Baseline to acute's time point (at the first day of intervention); Acute to chronic's time point (after 15 sections); Chronic's to follow-up time point (at 15 days after end point of interventions).
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Federal University of Sao Paulo
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Marco T De Mello, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of São Paulo
name: Adressa Silva, MD
role: STUDY_CHAIR
affiliation: Federal University of São Paulo
name: Sandra S Queiroz
role: STUDY_CHAIR
affiliation: Federal University of São Paulo
name: Mônica L Andersen, Ph.D
role: STUDY_CHAIR
affiliation: Federal University of São Paulo
name: Marcos Mônico-Neto
role: STUDY_CHAIR
affiliation: Federal University of São Paulo
name: Raquel MS Campos, MD
role: STUDY_CHAIR
affiliation: Federal University of São Paulo
name: Suely Roizenblatt, Ph.D
role: STUDY_CHAIR
affiliation: Federal University of São Paulo
name: Sergio Tufik, Ph.D
role: STUDY_CHAIR
References:
citation: Vitorino DF, Carvalho LB, Prado GF. Hydrotherapy and conventional physiotherapy improve total sleep time and quality of life of fibromyalgia patients: randomized clinical trial. Sleep Med. 2006 Apr;7(3):293-6. doi: 10.1016/j.sleep.2005.09.002. Epub 2006 Mar 24.
citation: Langhorst J, Musial F, Klose P, Hauser W. Efficacy of hydrotherapy in fibromyalgia syndrome--a meta-analysis of randomized controlled clinical trials. Rheumatology (Oxford). 2009 Sep;48(9):1155-9. doi: 10.1093/rheumatology/kep182. Epub 2009 Jul 16.
citation: Evcik D, Kizilay B, Gokcen E. The effects of balneotherapy on fibromyalgia patients. Rheumatol Int. 2002 Jun;22(2):56-9. doi: 10.1007/s00296-002-0189-8. Epub 2002 Mar 29.
citation: Bunnell DE, Agnew JA, Horvath SM, Jopson L, Wills M. Passive body heating and sleep: influence of proximity to sleep. Sleep. 1988 Apr;11(2):210-9. doi: 10.1093/sleep/11.2.210.
citation: Jordan J, Montgomery I, Trinder J. The effect of afternoon body heating on body temperature and slow wave sleep. Psychophysiology. 1990 Sep;27(5):560-6. doi: 10.1111/j.1469-8986.1990.tb01976.x.