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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01872676
Other study ID # U1111-1144-0316
Secondary ID
Status Completed
Phase N/A
First received June 4, 2013
Last updated June 4, 2013
Start date January 2011
Est. completion date December 2012

Study information

Verified date June 2013
Source Universidade Metodista de Piracicaba
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

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%.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date December 2012
Est. primary completion date January 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 30 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Spine manipulation

Manipulation sham


Locations

Country Name City State
Brazil Methodist University of Piracicaba Piracicaba São Paulo

Sponsors (1)

Lead Sponsor Collaborator
Universidade Metodista de Piracicaba

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Skin temperature 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 No
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