Asymptomatic StateMTCLNCT02440412
Effect of Massage Therapy in Cortisol Level
A study testing Massage Therapy and Rest in supine in people with Asymptomatic State, run by University of Chile at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Asymptomatic State
- What is being tested?
- Massage Therapy and Rest in supine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteChile
- Study dates
- Jul 2014to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Office/administrative workers of Faculty of Medicine, University of Chile.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Chile1 site
Faculty of Medicine, University of Chile
Santiago, Santiago Metropolitan, 8380453
About this study
Official title: 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.
Read the 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).
- Conditions
- Asymptomatic State
- Being tested
- Massage Therapy, Rest in supine
- Keywords
- Massage, Stress, salivary cortisol
- Medical subject headings
- Asymptomatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massage TherapyOther
It's a Physical Therapy manual procedure, based in Swedish technique, and applied in a standirzed way for all participants (stroke, kneading, pressure).
Rest in supineOther
It's only rest, in a clinic stretcher, with warm ambient temperature, and listening relaxing music with headphones.
| Study group | Role | What they receive |
|---|---|---|
| Massage Therapy | Experimental | A 45 minutes massage therapy (manual) standardized session, based in Swedish techniques. Receives: Other: Massage Therapy |
| Rest condition | Placebo comparator | 45 minutes of rest in supine position, listening music with headphones, and warm condition. Receives: Other: Rest in supine |
| Control | No intervention | Normal working condition, as a office workers (secretaries and managements employees) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Salivary Cortisol Level
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.
Measured: All participants were measured in three different condition, one week apart one each other. In each condition, three measurements were performed, in the morning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startJul 2014
- Primary completionNov 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Asymptomatic StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Antonio Rojo Castro, University of Chile
- Investigators
- Rodrigo A Rojo, Msc., Principal investigator, Physical Therapy Department, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440412
- Sponsor's protocol ID
- Kine015
- Acronym
- MTCL
- Status last verified
- May 2015
- First submitted
- 1 May 2015
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 14717648Rapaport 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.
PubMed 22775448Field 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.
PubMed 8884390Lindgren 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.
PubMed 20638912Arroyo-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.
PubMed 19197204Lovas 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.
PubMed 21147413Field 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.
PubMed 17041326Field 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.
PubMed 16162447Moraska 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.
PubMed 18955340Field 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.
PubMed 25172313
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Single Session of Massage Therapy in Salivary Cortisol Levels in Asymptomatic Persons With Administrative Tasks and / or Office Work.
- ClinicalTrials.gov ID
- NCT02440412
- Acronym / sponsor ID
- MTCL / Kine015
- Conditions
- Asymptomatic State
- Keywords
- Massage, Stress, salivary cortisol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 12 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Massage Therapy | Experimental | Other: Massage TherapyA 45 minutes massage therapy (manual) standardized session, based in Swedish techniques. |
| Rest condition | Placebo comparator | Other: Rest in supine45 minutes of rest in supine position, listening music with headphones, and warm condition. |
| Control | No intervention | –Normal working condition, as a office workers (secretaries and managements employees) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Office/administrative workers of Faculty of Medicine, University of Chile.
Key exclusion criteria (8 listed)
- Musculoskeletal disease or injury in spine.
- Body Mass Index over 35.
- Smoking (over three cigars at day)
- Depression.
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Massage TherapyIt's a Physical Therapy manual procedure, based in Swedish technique, and applied in a standirzed way for all participants (stroke, kneading, pressure). | Other | Massage Therapy |
| Rest in supineIt's only rest, in a clinic stretcher, with warm ambient temperature, and listening relaxing music with headphones. | Other | Rest condition |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
- Background: PubMed 14717648Moyer 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.
- Results publication: PubMed 22775448Rapaport 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.
- Results publication: PubMed 8884390Field 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.
- Results publication: PubMed 20638912Lindgren 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.
- Results publication: PubMed 19197204Arroyo-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.
- Results publicationLovas J. The effects of massage therapy on the human immune response in healthy adults. J Bodyw Mov Ther. 2002; 143-150
- Results publication: PubMed 21147413Moyer 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.
- Results publicationField T, Diego M, Hernandez-Rief M. Massage therapy research. Developmental Review. 2007; 27: 75-8
- Results publication: PubMed 17041326Field 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.
- Results publication: PubMed 16162447Field 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.
- Results publication: PubMed 18955340Moraska 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.
- Results publication: PubMed 25172313Field 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodrigo A Rojo, Msc. principal investigator
Physical Therapy Department, University of Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage Therapy and Rest in supine in people with Asymptomatic State, run by University of Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02440412, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2015; AzTrials last refreshed its copy on 31 Oct 2026.