Passive Body Heating, Sleep and Fibromyalgia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marco Tulio de Mello, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01557062
First received: March 9, 2012
Last updated: March 15, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Fibromyalgia
Other: Polysomnography
Other: Teperature measure
Other: Fibromyalgia Impact questionary

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Passive Body Heating Improves The Sleep Pattern In Women Patients Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Sleep Pattern [ 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). ] [ Designated as safety issue: Yes ]
    Polysomnographies's register


Secondary Outcome Measures:
  • Impact of Fibromyalgia Disease [ Time Frame: 7 weeks- The measurements occurred at the following time points: baseline, chronic and follow-up. ] [ Designated as safety issue: Yes ]
    Fibromyalgia Impact Questionnaire (FIQ)

  • Changes in Core Body Temperature (CBT) [ 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). ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 25
Study Start Date: March 2009
Study Completion Date: December 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Polysomnography Other: Polysomnography
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.
Temperature measure Other: Teperature measure
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.
Fibromyalgia Impact questionary Other: Fibromyalgia Impact questionary
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.

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

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fibromyalgia diagnostic
  • Women
  • Post menopausal
  • Sedentary

Exclusion Criteria:

  • Other diagnosis of chronic illnesses
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01557062

Locations
Brazil
Federal University of Sao Paulo
Sao Paulo, SP, Brazil, 04020-050
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Marco T De Mello, Ph.D Federal University of São Paulo
Study Chair: Adressa Silva, MD Federal University of São Paulo
Study Chair: Sandra S Queiroz Federal University of São Paulo
Study Chair: Mônica L Andersen, Ph.D Federal University of São Paulo
Study Chair: Marcos Mônico-Neto Federal University of São Paulo
Study Chair: Raquel MS Campos, MD Federal University of São Paulo
Study Chair: Suely Roizenblatt, Ph.D Federal University of São Paulo
Study Chair: Sergio Tufik, Ph.D Federal University of São Paulo
  More Information

Publications:
Responsible Party: Marco Tulio de Mello, Ph.D, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01557062     History of Changes
Other Study ID Numbers: Fibromyalgia_0866/06
Study First Received: March 9, 2012
Last Updated: March 15, 2012
Health Authority: Brazil: Associação Fundo de Incentivo à Pesquisa
Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
Fibromyalgia
Hydrotherapy
Sleep
Pain
Body Temperature

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 15, 2014