- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02440412
Effect of Massage Therapy in Cortisol Level (MTCL)
May 6, 2015 updated by: Rodrigo Antonio Rojo Castro, University of Chile
Effects of a Single Session of Massage Therapy in Salivary Cortisol Levels in Asymptomatic Persons With Administrative Tasks and / or Office Work.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Santiago, Chile, 8380453
- Faculty of Medicine, University of Chile
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Massage Therapy
A 45 minutes massage therapy (manual) standardized session, based in Swedish techniques.
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It's a Physical Therapy manual procedure, based in Swedish technique, and applied in a standirzed way for all participants (stroke, kneading, pressure).
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Placebo Comparator: Rest condition
45 minutes of rest in supine position, listening music with headphones, and warm condition.
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It's only rest, in a clinic stretcher, with warm ambient temperature, and listening relaxing music with headphones.
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No Intervention: Control
Normal working condition, as a office workers (secretaries and managements employees)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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All participants were measured in three different condition, one week apart one each other. In each condition, three measurements were performed, in the morning
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rodrigo A Rojo, Msc., Physical Therapy Department, University of Chile
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Moyer CA, Rounds J, Hannum JW. A meta-analysis of massage therapy research. Psychol Bull. 2004 Jan;130(1):3-18. doi: 10.1037/0033-2909.130.1.3.
- Rapaport MH, Schettler P, Bresee C. A preliminary study of the effects of repeated massage on hypothalamic-pituitary-adrenal and immune function in healthy individuals: a study of mechanisms of action and dosage. J Altern Complement Med. 2012 Aug;18(8):789-97. doi: 10.1089/acm.2011.0071. Epub 2012 Jul 9.
- Field T, Ironson G, Scafidi F, Nawrocki T, Goncalves A, Burman I, Pickens J, Fox N, Schanberg S, Kuhn C. Massage therapy reduces anxiety and enhances EEG pattern of alertness and math computations. Int J Neurosci. 1996 Sep;86(3-4):197-205. doi: 10.3109/00207459608986710.
- Lindgren L, Rundgren S, Winso O, Lehtipalo S, Wiklund U, Karlsson M, Stenlund H, Jacobsson C, Brulin C. Physiological responses to touch massage in healthy volunteers. Auton Neurosci. 2010 Dec 8;158(1-2):105-10. doi: 10.1016/j.autneu.2010.06.011.
- Arroyo-Morales M, Olea N, Ruiz C, del Castilo Jde D, Martinez M, Lorenzo C, Diaz-Rodriguez L. Massage after exercise--responses of immunologic and endocrine markers: a randomized single-blind placebo-controlled study. J Strength Cond Res. 2009 Mar;23(2):638-44. doi: 10.1519/JSC.0b013e318196b6a6.
- Lovas J. The effects of massage therapy on the human immune response in healthy adults. J Bodyw Mov Ther. 2002; 143-150
- Moyer CA, Seefeldt L, Mann ES, Jackley LM. Does massage therapy reduce cortisol? A comprehensive quantitative review. J Bodyw Mov Ther. 2011 Jan;15(1):3-14. doi: 10.1016/j.jbmt.2010.06.001. Epub 2010 Jul 2.
- Field T, Diego M, Hernandez-Rief M. Massage therapy research. Developmental Review. 2007; 27: 75-8
- Field T, Diego M, Cullen C, Hernandez-Reif M, Sunshine W, Douglas S. Fibromyalgia pain and substance P decrease and sleep improves after massage therapy. J Clin Rheumatol. 2002 Apr;8(2):72-6. doi: 10.1097/00124743-200204000-00002.
- Field T, Hernandez-Reif M, Diego M, Schanberg S, Kuhn C. Cortisol decreases and serotonin and dopamine increase following massage therapy. Int J Neurosci. 2005 Oct;115(10):1397-413. doi: 10.1080/00207450590956459.
- Moraska A, Pollini RA, Boulanger K, Brooks MZ, Teitlebaum L. Physiological adjustments to stress measures following massage therapy: a review of the literature. Evid Based Complement Alternat Med. 2010 Dec;7(4):409-18. doi: 10.1093/ecam/nen029. Epub 2008 May 7.
- Field T. Massage therapy research review. Complement Ther Clin Pract. 2014 Nov;20(4):224-9. doi: 10.1016/j.ctcp.2014.07.002. Epub 2014 Aug 1.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
May 1, 2015
First Submitted That Met QC Criteria
May 6, 2015
First Posted (Estimate)
May 12, 2015
Study Record Updates
Last Update Posted (Estimate)
May 12, 2015
Last Update Submitted That Met QC Criteria
May 6, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Kine015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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