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Completed

NCT Number: NCT02164123

Autonomic Effects of T4 Mobilization in Asymptomatic Subjects

The purpose of this study is to determine whether passive accessory intervertebral mobilization applied to the fourth thoracic vertebra produces autonomic effects.

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Key information

Conditions

Other Disorders of the Autonomic Nervous System Vertebra; Degeneration

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal de Ciências da Saúde de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

About this study

Asymptomatic subjects will be recruited to this study. Pressure pain threshold, heart rate, heart rate variability and skin conductance will be measured before, immediately after and fifteen minutes after the intervention.

Subjects will be randomized into three groups: Passive accessory intervertebral mobilization one, passive accessory intervertebral mobilization two and placebo group.

The researcher that will do the intervention will be blinded to the outcomes measures, and the researcher that will do the measurements will be blind to the intervention.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Asymptomatic subjects
  • Aged between 18 - 40 years old
  • Portuguese readers and writers

Exclusion criteria

  • History of lesion or surgery to the spine

Treatment and study plan

Spinal mobilization

Other

Experimental group

Other names: Postero-anterior spinal mobilization in prone

Spinal Mobilization II

Other

Active comparator group

Other names: Postero-anterior spinal mobilization in seated position

Placebo

Other

Placebo group

Other names: Placebo technique, olny manual contact

Primary outcomes

  1. Skin conductance

    Time frame: Change from Baseline imediately after, and 15 minutes after the intervention

    Skin conductance will be measured with Biopac MP150, the electrodes will be attached to the third and fourth fingers bilaterally. This measurement will be made during all the procedure, before, during and until 15 minutes after the intervention.

Secondary outcomes

  1. Pressure pain threshold

    Time frame: Change from Baseline imediately after, and 15 minutes after the intervention

    Pressure pain threshold will be measured with a digital algometer (Model FDX 10; Wagner Instruments, Greenwich, CT). This measurement will be made on the spinous process of C5 and T4, on the first dorsal interossei, and on the anterior tibial tuberosity bilaterally.

Other outcomes

  1. Heart rate variability

    Time frame: Change from Baseline imediately after the intervention

    Heart rate variability will be measured with a Polar Advantage Interface (Polar Electro Oy, Kempele, Finland). The belt will be positioned centrally, directly below the xiphisternum. Heart rate data acquisition will me made for 5 minutes at baseline and for 5 minutes immediately after the intervention.

Sponsors and collaborators

Lead sponsor

Federal University of Health Science of Porto Alegre

Other

Registry information

Official study title

Autonomic Effects of T4 Mobilization in Asymptomatic Subjects: Randomized Clinical Trial

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 16, 2014
Registry last updated
Mar 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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