Autonomic Effects of T4 Mobilization in Asymptomatic Subjects

Vertebra; Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02164123
• Other study ID #: UFCSPA-FXA-01
• Status: Completed
• Phase: N/A
• First received: June 9, 2014
• Last updated: March 5, 2015
• Start date: July 2014
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: Federal University of Health Science of Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: December 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autonomic Nervous System Diseases
• Other Disorders of the Autonomic Nervous System
• Primary Dysautonomias
• Vertebra; Degeneration

Intervention

Other:
• Spinal mobilization
Experimental group
• Spinal Mobilization II
Active comparator group
• Placebo
Placebo group

Locations

Country	Name	City	State
Brazil	Universidade Federal de Ciências da Saúde de Porto Alegre	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Health Science of Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Yes
Primary	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	Yes
Secondary	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	Yes