Immediate Effects of Upper Thoracic Manipulation on Skin Surface Temperature of T3 Vertebral Region and Biceps Brachii Muscle

June 4, 2013 updated by: Amanda Carine Packer, Universidade Metodista de Piracicaba
The aim of the present study was to assess the immediate effects of upper thoracic manipulation on skin surface temperature in the region of the T3 vertebra and biceps brachii muscle in healthy women. It is a randomized controlled blind study. Twenty-six healthy women of the university community were randomly allocated to an experimental group (n = 13) and a placebo group (n = 13). A single session of the upper thoracic spine manipulation (segment T3)was performed. Infrared thermography was used to determine changes in skin surface temperature in the region of T3 and the biceps brachii muscle, which would indirectly reflect sympathetic activity. Images were taken prior to manipulation, immediately after and both five and 10 minutes after manipulation. Repeated measures ANOVA with the post hoc Bonferroni test and the independent samples t-test were used for the intragroup and intergroup comparisons, respectively, with the level of significance set to 5%.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

26

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

    • São Paulo
      • Piracicaba, São Paulo, Brazil, 13.423-170
        • Methodist University of Piracicaba

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 30 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy women
  • 18 and 30 years of age

Exclusion Criteria:

  • use of vasoactive medication
  • body mass index greater than 25 kg/m2
  • having undergone spinal manipulation in previous month
  • and any red flag sign, such as malignant tumor, inflammatory or infectious disease that contraindicated manual therapy

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Manipulation
The experimental group received upper thoracic manipulation of the T3 vertebra. The volunteer was instructed to lie in the supine position, interlace her fingers and position her hands in the posterior region of the base of the neck. The therapist than positioned a stabilizing hand in a pistol grip immediately caudal to the T3 vertebra, pushing the volunteer's arms downward to generate flexion of the upper thoracic spine.
SHAM_COMPARATOR: Sham
The placebo group was placed precisely as the experimental group, with the exception of the positioning of the therapist's hand, which remained with the palm open and not in a pistol grip. Once positioned, the volunteers were instructed to breathe deeply. The maneuver was terminated after one cycle of deep breathing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin temperature
Time Frame: 1 years
Infrared thermography was used to determine changes in skin surface temperature in the region of T3 and the biceps brachii muscle, which would indirectly reflect sympathetic activity. Images were taken prior to manipulation, immediately after and both five and 10 minutes after manipulation.
1 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Amanda Packer, MSc, Universidade Metodista de Piracicaba

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.

Helpful Links

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

January 1, 2011

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

June 4, 2013

First Submitted That Met QC Criteria

June 4, 2013

First Posted (ESTIMATE)

June 7, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

June 7, 2013

Last Update Submitted That Met QC Criteria

June 4, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • U1111-1144-0316

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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