Passive Body Heating, Sleep and Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Passive Body Heating Improves The Sleep Pattern In Women Patients Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01557062
• Other study ID #: Fibromyalgia_0866/06
• Status: Completed
• Phase: N/A
• First received: March 9, 2012
• Last updated: March 15, 2012
• Start date: March 2009
• Est. completion date: December 2010

Study information

• Verified date: March 2012
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Associação Fundo de Incentivo à PesquisaBrazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 70 Years

Eligibility

Inclusion Criteria:

• Fibromyalgia diagnostic

• Women

• Post menopausal

• Sedentary

Exclusion Criteria:

• Other diagnosis of chronic illnesses

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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.
• 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
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.

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

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. — View Citation

Evcik D, Kizilay B, Gökçen E. The effects of balneotherapy on fibromyalgia patients. Rheumatol Int. 2002 Jun;22(2):56-9. Epub 2002 Mar 29. — View 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. — View Citation

Langhorst J, Musial F, Klose P, Häuser 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. Review. — View 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. Epub 2006 Mar 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Yes
Secondary	Impact of Fibromyalgia Disease	Fibromyalgia Impact Questionnaire (FIQ)	7 weeks- The measurements occurred at the following time points: baseline, chronic and follow-up.	Yes
Secondary	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.	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).	Yes