Passive Body Heating, Sleep and Fibromyalgia

NCT01557062 | Completed DMC

• 1 other identifier: Fibromyalgia_0866/06
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Hydrotherapy; Sleep; Pain; Body Temperature

Outcome Measures

Primary Outcomes (1)

• Sleep Pattern

  Polysomnographies's register

  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 (2)

• Impact of Fibromyalgia Disease

  7 weeks- The measurements occurred at the following time points: baseline, chronic and follow-up.

• Changes in Core Body Temperature (CBT)

  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).

Study Arms (3)

Polysomnography

OTHER

Other: Polysomnography

Temperature measure

OTHER

Other: Teperature measure

Fibromyalgia Impact questionary

OTHER

Other: Fibromyalgia Impact questionary

Interventions

Polysomnography OTHER

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.

Polysomnography

Teperature measure OTHER

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.

Temperature measure

Fibromyalgia Impact questionary OTHER

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.

Fibromyalgia Impact questionary

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fibromyalgia diagnostic
• Women
• Post menopausal
• Sedentary

You may not qualify if:

• Other diagnosis of chronic illnesses

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University of Sao Paulo

São Paulo, São Paulo, 04020-050, Brazil

Location

Related Publications (5)

• 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.

  PMID: 16564209 BACKGROUND

• 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.

  PMID: 19608724 BACKGROUND

• 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.

  PMID: 12070676 BACKGROUND

• 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.

  PMID: 3381061 BACKGROUND

• 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.

  PMID: 2274619 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marco T De Mello, Ph.D

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D

Study Record Dates

• First Submitted: March 9, 2012
• First Posted: March 19, 2012
• Study Start: March 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 19, 2012

Record last verified: 2012-03

Locations

BR (1)