Autonomic Effects of T4 Mobilization in Asymptomatic Subjects

NCT02164123 | Completed DMC

• 1 other identifier: UFCSPA-FXA-01
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Other Disorders of the Autonomic Nervous System; Vertebra; Degeneration

Keywords

Autonomic effects; spinal mobilization; clinical trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pressure pain threshold

  Change from Baseline imediately after, and 15 minutes after the intervention

Other Outcomes (1)

• Heart rate variability

  Change from Baseline imediately after the intervention

Study Arms (3)

Spinal mobilization

EXPERIMENTAL

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

Spinal Mobilization II

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Spinal mobilization OTHER

Experimental group

Also known as: Postero-anterior spinal mobilization in prone

Spinal mobilization

Spinal Mobilization II OTHER

Active comparator group

Also known as: Postero-anterior spinal mobilization in seated position

Spinal Mobilization II

Placebo OTHER

Placebo group

Also known as: Placebo technique, olny manual contact

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• History of lesion or surgery to the spine

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead

Study Sites (1)

Universidade Federal de Ciências da Saúde de Porto Alegre

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

Location

MeSH Terms

Interventions

Prone Position; Sitting Position

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Francisco De Araujo, Pt

  Federal University of Health Science of Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pt

Study Record Dates

• First Submitted: June 9, 2014
• First Posted: June 16, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 9, 2015

Record last verified: 2015-03

Locations

BR (1)