Autonomic Effects of T4 Mobilization in Asymptomatic Subjects

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

Detailed Description
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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.

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

Conditions
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Other Disorders of the Autonomic Nervous System, Vertebra; Degeneration

Intervention / Treatment
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* Other: Spinal mobilization
* Other: Spinal Mobilization II
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Asymptomatic subjects Aged between 18 - 40 years old Portuguese readers and writers Exclusion Criteria: History of lesion or surgery to the spine

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spinal mobilization<br>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<br>* Experimental group<br>* Other names: Postero-anterior spinal mobilization in prone;|
| Active Comparator: Spinal Mobilization II<br>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<br>* Active comparator group<br>* Other names: Postero-anterior spinal mobilization in seated position;|
| Placebo Comparator: Placebo<br>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<br>* Placebo group<br>* Other names: Placebo technique, olny manual contact;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autonomic effects, spinal mobilization, clinical trial