Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Massage Therapy in Cortisol Level (MTCL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02440412
Recruitment Status : Completed
First Posted : May 12, 2015
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):
Rodrigo Antonio Rojo Castro, University of Chile

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study evaluates the effect of a single session of Massage Therapy in salivary cortisol level. All participants were assessed on three conditions: Massage session, rest in supine position listening music, and under normal working conditions. The hypothesis of the investigators is that the effect of the massage action in reduction of cortisol is superior to only rest.

Condition or disease Intervention/treatment Phase
Asymptomatic State Other: Massage Therapy Other: Rest in supine Not Applicable

Detailed Description:
Several studies have postulated that one of the physiological markers of the effect of massage therapy is to reduce the level of cortisol, the "stress hormone". However it is not clear whether the effect is due to the manual action on the skin, or only by the relaxation induced rest. Therefore the variation of salivary cortisol in both conditions, and also in everyday working conditions was compared. Cortisol has a circadian cycle, with a maximum value upon awakening, which decreases during the morning; therefore a sample of saliva (in Salivette tube) it was collected in the three experimental conditions at the same hour time in the morning: 8:45(after intervention), and 9:30 and 10.30 (both, before).
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of a Single Session of Massage Therapy in Salivary Cortisol Levels in Asymptomatic Persons With Administrative Tasks and / or Office Work.
Study Start Date : July 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : March 2015
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Massage Therapy
A 45 minutes massage therapy (manual) standardized session, based in Swedish techniques.
 Other: Massage Therapy
It's a Physical Therapy manual procedure, based in Swedish technique, and applied in a standirzed way for all participants (stroke, kneading, pressure).
Placebo Comparator: Rest condition
45 minutes of rest in supine position, listening music with headphones, and warm condition.
 Other: Rest in supine
It's only rest, in a clinic stretcher, with warm ambient temperature, and listening relaxing music with headphones.
No Intervention: Control
Normal working condition, as a office workers (secretaries and managements employees)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change of Salivary Cortisol Level [ Time Frame: All participants were measured in three different condition, one week apart one each other. In each condition, three measurements were performed, in the morning ]
    Data (a saliva sample in a Salivette (r) tube) were collected at: immediately before the intervention and placebo procedure, immediately after and later, one hour after. The control condition (normal working condition) was measured at the same hours (8:45 AM, 9.30 AM and 10.30 AM) in the workplace. After collected, were refrigerated.The three conditions (intervention, placebo and office work) were a week apart. Therefore, each participant had nine measurements. Determining the level of cortisol was performed by ELISA method, after all samples were collected.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Office/administrative workers of Faculty of Medicine, University of Chile.

Exclusion Criteria:

  • Musculoskeletal disease or injury in spine.
  • Body Mass Index over 35.
  • Smoking (over three cigars at day)
  • Depression.
  • Pregnancy
  • Corticosteroid treatment.
  • Skin wound or disease.
  • Intolerance to the prone position.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02440412


Locations
Layout table for location information
Chile
Faculty of Medicine, University of Chile
Santiago, Chile, 8380453
Sponsors and Collaborators
University of Chile
Investigators
Layout table for investigator information
Principal Investigator: Rodrigo A Rojo, Msc. Physical Therapy Department, University of Chile
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:
Lovas J. The effects of massage therapy on the human immune response in healthy adults. J Bodyw Mov Ther. 2002; 143-150
Field T, Diego M, Hernandez-Rief M. Massage therapy research. Developmental Review. 2007; 27: 75-8

Other Publications:

Layout table for additonal information
Responsible Party: Rodrigo Antonio Rojo Castro, Academic Of Department of Physical Therapy, University of Chile
ClinicalTrials.gov Identifier: NCT02440412    
Other Study ID Numbers: Kine015
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: May 2015
Keywords provided by Rodrigo Antonio Rojo Castro, University of Chile:
Massage
Stress
salivary cortisol
Additional relevant MeSH terms:
Layout table for MeSH terms
Asymptomatic Diseases
Disease Attributes
Pathologic Processes