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Passive Body Heating, Sleep and Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Polysomnography
Teperature measure
Fibromyalgia Impact questionary
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Hydrotherapy, Sleep, Pain, Body Temperature

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Fibromyalgia diagnostic
  • Women
  • Post menopausal
  • Sedentary

Exclusion Criteria:

  • Other diagnosis of chronic illnesses

Sites / Locations

  • Federal University of Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Polysomnography

Temperature measure

Fibromyalgia Impact questionary

Arm Description

Outcomes

Primary Outcome Measures

Sleep Pattern
Polysomnographies's register

Secondary Outcome Measures

Impact of Fibromyalgia Disease
Fibromyalgia Impact Questionnaire (FIQ)
Changes in Core Body Temperature (CBT)
was monitored continuously throughout the nights at baseline and on days of the experimental protocols by a thermistor pill with a CorTemp HT150002 and core temperature sensor coupled with a data recorder.

Full Information

First Posted
March 9, 2012
Last Updated
March 15, 2012
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01557062
Brief Title
Passive Body Heating, Sleep and Fibromyalgia
Official Title
Passive Body Heating Improves The Sleep Pattern In Women Patients Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Hydrotherapy, Sleep, Pain, Body Temperature

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Polysomnography
Arm Type
Other
Arm Title
Temperature measure
Arm Type
Other
Arm Title
Fibromyalgia Impact questionary
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Polysomnography
Intervention Description
The Embla® S7000 was used to record full-night at the Sleep Institute (São Paulo, Brazil). The sensors were attached to the patient in a non-invasive manner using tape or rubber bands. The physiological variables were monitored simultaneously and continuously: 4 channels of EEG, 2 of EOG, 4 of EMG and 1 channel of ECG. Airflow detection was made through 2 channels using a pair of thermal sensors and nasal pressure. Respiratory effort of the chest and abdomen, were measured by respiratory inductance plethysmography. Oxygen saturation, were measured with a pulse oximeter. Sleep stages were visually scored in all the PSG according to standardized criteria for the investigation of sleep macrostructure.
Intervention Type
Other
Intervention Name(s)
Teperature measure
Intervention Description
Core body temperature was assessed using a thermistor pill (sensor), which is an electronic device 2.23 cm in length and 1.06 cm in diameter that records body temperature and transmits it to a receptor located at the patient's waist called the Core Body Temperature Monitoring System (CorTempTM), that is powered by a silver oxide battery. The components of the sensor are encapsulated in epoxy resin and coated with silicone (HQ Inc., Florida, USA). To ensure that the sensor would be in the intestines and not the stomach, the pill was ingested at least 2 hours (h) before beginning temperature recording. The CBT was recorded every 30 minutes (min) between 10:00pm and 7:00am. The time of pill elimination is variable between individuals and may be as long as 48h.
Intervention Type
Other
Intervention Name(s)
Fibromyalgia Impact questionary
Intervention Description
The FIQ is an instrument used to assess the quality of life specifically for patients with FM. This questionnaire consists of 19 questions related to functional capacity, employment status, general well being, psychological disorders and physical symptoms. The higher the score is, the greater is the impact of FM in the individual's quality of life. This questionnaire was validated for Brazilian's population in 2006.
Primary Outcome Measure Information:
Title
Sleep Pattern
Description
Polysomnographies's register
Time Frame
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 Outcome Measure Information:
Title
Impact of Fibromyalgia Disease
Description
Fibromyalgia Impact Questionnaire (FIQ)
Time Frame
7 weeks- The measurements occurred at the following time points: baseline, chronic and follow-up.
Title
Changes in Core Body Temperature (CBT)
Description
was monitored continuously throughout the nights at baseline and on days of the experimental protocols by a thermistor pill with a CorTemp HT150002 and core temperature sensor coupled with a data recorder.
Time Frame
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).

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Fibromyalgia diagnostic Women Post menopausal Sedentary Exclusion Criteria: Other diagnosis of chronic illnesses
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco T De Mello, Ph.D
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adressa Silva, MD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sandra S Queiroz
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mônica L Andersen, Ph.D
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marcos Mônico-Neto
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Raquel MS Campos, MD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Suely Roizenblatt, Ph.D
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sergio Tufik, Ph.D
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Federal University of Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04020-050
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
16564209
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.
Results Reference
background
PubMed Identifier
19608724
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.
Results Reference
background
PubMed Identifier
12070676
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.
Results Reference
background
PubMed Identifier
3381061
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.
Results Reference
background
PubMed Identifier
2274619
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.
Results Reference
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Passive Body Heating, Sleep and Fibromyalgia

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