NCT02440412

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
Last Updated

May 12, 2015

Status Verified

May 1, 2015

Enrollment Period

4 months

First QC Date

May 1, 2015

Last Update Submit

May 6, 2015

Conditions

Asymptomatic State

Keywords

MassageStresssalivary cortisol

Outcome Measures

Primary Outcomes (1)

  • 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.

    All participants were measured in three different condition, one week apart one each other. In each condition, three measurements were performed, in the morning

Study Arms (3)

Massage Therapy

EXPERIMENTAL

A 45 minutes massage therapy (manual) standardized session, based in Swedish techniques.

Other: Massage Therapy

Rest condition

PLACEBO COMPARATOR

45 minutes of rest in supine position, listening music with headphones, and warm condition.

Other: Rest in supine

Control

NO INTERVENTION

Normal working condition, as a office workers (secretaries and managements employees)

Interventions

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).

Massage Therapy
Rest in supineOTHER

It's only rest, in a clinic stretcher, with warm ambient temperature, and listening relaxing music with headphones.

Rest condition

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, University of Chile

Santiago, Santiago Metropolitan, 8380453, Chile

Location

Related Publications (12)

  • 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.

    PMID: 14717648BACKGROUND

  • 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.

    PMID: 22775448RESULT

  • 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.

    PMID: 8884390RESULT

  • 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.

    PMID: 20638912RESULT

  • 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.

    PMID: 19197204RESULT

  • Lovas J. The effects of massage therapy on the human immune response in healthy adults. J Bodyw Mov Ther. 2002; 143-150

    RESULT

  • 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.

    PMID: 21147413RESULT

  • Field T, Diego M, Hernandez-Rief M. Massage therapy research. Developmental Review. 2007; 27: 75-8

    RESULT

  • 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.

    PMID: 17041326RESULT

  • 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.

    PMID: 16162447RESULT

  • 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.

    PMID: 18955340RESULT

  • 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.

    PMID: 25172313RESULT

MeSH Terms

Conditions

Asymptomatic Diseases

Interventions

MassageRE1-silencing transcription factorSupine Position

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationPostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Rodrigo A Rojo, Msc.

    Physical Therapy Department, University of Chile

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Academic Of Department of Physical Therapy

Study Record Dates

First Submitted

May 1, 2015

First Posted

May 12, 2015

Study Start

July 1, 2014

Primary Completion

November 1, 2014

Study Completion

March 1, 2015

Last Updated

May 12, 2015

Record last verified: 2015-05

Locations

CL(1)