Autonomic Effects of T4 Mobilization in Asymptomatic Subjects

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

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

Study Overview

• Status: Completed
• Conditions: Vertebra; Degeneration; Other Disorders of the Autonomic Nervous System
• Intervention / Treatment: Other: Placebo; Other: Spinal mobilization; Other: Spinal Mobilization II

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Porto Alegre, RS, Brazil, 90050-170
      • Universidade Federal de Ciências da Saúde de Porto Alegre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• History of lesion or surgery to the spine

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spinal mobilization; 20 subjects will be randomized to this arm. A postero-anterior (PA) mobilization, to the fourth thoracic vertebra will be applied, for 3 sets of one minute. The subject will be comfortable prone lying.	Other: Spinal mobilization; Experimental group; Other Names: Postero-anterior spinal mobilization in prone
Active Comparator: Spinal Mobilization II; 20 subjects will be randomized to this arm. A postero-anterior (PA) mobilization, to the fourth thoracic vertebra will be applied, for 3 sets of one minute, but in this case, the subject will be seated, in a position that influence the sympathetic trunk, at the thorax.	Other: Spinal Mobilization II; Active comparator group; Other Names: Postero-anterior spinal mobilization in seated position
Placebo Comparator: Placebo; 20 subjects will be randomized to this arm. Only manual contact will be applied, without any oscillation. The subject will be comfortable prone lying. The intervention time is the same of the other arms.	Other: Placebo; Placebo group; Other Names: Placebo technique, olny manual contact

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin conductance	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.	Change from Baseline imediately after, and 15 minutes after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pressure pain threshold	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.	Change from Baseline imediately after, and 15 minutes after the intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate variability	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.	Change from Baseline imediately after the intervention

Collaborators and Investigators

• Sponsor: Federal University of Health Science of Porto Alegre
• Investigators: Principal Investigator: Francisco De Araujo, Pt, Federal University of Health Science of Porto Alegre

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: June 9, 2014
• First Submitted That Met QC Criteria: June 12, 2014
• First Posted (Estimate): June 16, 2014

Study Record Updates

• Last Update Posted (Estimate): March 9, 2015
• Last Update Submitted That Met QC Criteria: March 5, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: clinical trial; spinal mobilization; Autonomic effects
• Additional Relevant MeSH Terms: Nervous System Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases
• Other Study ID Numbers: UFCSPA-FXA-01