- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01872676
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
Conditions
Intervention / Treatment
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
-
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São Paulo
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Piracicaba, São Paulo, Brazil, 13.423-170
- Methodist University of Piracicaba
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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 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.
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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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