NCT01872676

Brief 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%.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

Typical duration 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

January 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 7, 2013

Completed
Last Updated

June 7, 2013

Status Verified

June 1, 2013

Enrollment Period

1 year

First QC Date

June 4, 2013

Last Update Submit

June 4, 2013

Conditions

Keywords

ThermographySkin TemperatureManipulation, SpinalPhysical Therapy Modalities

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Manipulation

EXPERIMENTAL

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.

Other: Spine manipulation

Sham

SHAM COMPARATOR

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.

Other: Manipulation sham

Interventions

Manipulation

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy women
  • and 30 years of age

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist University of Piracicaba

Piracicaba, São Paulo, 13.423-170, Brazil

Location

Related Links

MeSH Terms

Interventions

Manipulation, Spinal

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Officials

  • Amanda Packer, MSc

    Universidade Metodista de Piracicaba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Amanda Carine Packer

Study Record Dates

First Submitted

June 4, 2013

First Posted

June 7, 2013

Study Start

January 1, 2011

Primary Completion

January 1, 2012

Study Completion

December 1, 2012

Last Updated

June 7, 2013

Record last verified: 2013-06

Locations