Effects of the T12-L1 Vertebral Manipulation on Body Temperature, Arterial Tension and Cardiac Frequency

Study Overview
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Brief Summary
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Single-blinded Randomized Controlled Trial conducted amongst a sample of healthy subjects divided into two different groups: the experimental treatment will consist in bilateral T12-L1 vertebral manipulation, whereas the control group will receive a sham intervention consisting solely in applying tension without properly manipulating. Body temperature, arterial tension and cardiac frequency will be measured before and after the intervention. Changes in the aforementioned variables will be measured.

Detailed Description
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The current study will correspond to a single-blinded Randomized Controlled Trial with two arms, conducted amongst a sample of healthy subjects, who will be divided into two different groups: the experimental treatment will consist in bilateral T12-L1 vertebral manipulation, whereas the control group will receive a sham intervention consisting solely in applying tension without properly manipulating. Three different variables will be measured prior to and after the intervention: body temperature, arterial tension and cardiac frequency, to subsequently calculate possible changes in the variables, with the aim of establishing the effect of the manipulation and/or sham treatment.

Official Title
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Effects of the T12-L1 Vertebral Manipulation on Body Temperature, Arterial Tension and Cardiac Frequency

Conditions
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Healthy Subjects, Spinal Manipulation, Manual Therapy

Intervention / Treatment
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* Other: Bilateral vertebral manipulation of the T12-L1 vertebra through manual therapy
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both genders; Over 18 years of age; Minimal amount of exercise per week: 1 hour/week; Covid-related aspects: Negative antigen-test 24 hours before the test or negative PCR 48 hours before the test. Exclusion Criteria: Surgical intervention in the 5 years previous to the study; Any acute or chronic medical condition; Any pharmacological treatment; Osteosynthetic implants.

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
Interventional Model Description: Single-blinded Randomized Controlled Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Bilateral vertebral manipulation of the T12-L1 vertebra | Other: Bilateral vertebral manipulation of the T12-L1 vertebra through manual therapy<br>* Bilateral vertebral manipulation of the T12-L1 vertebra through manual therapy<br>|
| Placebo Comparator: Placebo<br>Application of slight manual tension to the vertebra without reaching a manipulation thrust | Other: Placebo<br>* Manual tension without reaching the manipulation thrust<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body temperature | Body temperature: Celsius degree will be measured by means of a digital thermometer | Change from baseline Body Temperature to ten minutes after the intervention | 
| Body temperature | Body temperature: Celsius degree will be measured by means of a digital thermometer | Change from baseline Body Temperature to seven days after the intervention | 
| Cardiac frequency | Cardiac frequency: Beats per minute will be measured by means of OMRON M4 device, in compliance with the European Directive 93/42/EEC | Change from baseline Cardiac Frequency to ten minutes after the intervention | 
| Cardiac frequency | Cardiac frequency: Beats per minute will be measured by means of OMRON M4 device, in compliance with the European Directive 93/42/EEC | Change from baseline Cardiac Frequency to seven days after the intervention | 
| Arterial tension | Arterial tension (systolic/diastolic) will be measured by means of OMRON M4 device, in compliance with the European Directive 93/42/EEC | Change from baseline arterial tension to ten minutes after the intervention | 
| Arterial tension | Arterial tension (systolic/diastolic) will be measured by means of OMRON M4 device, in compliance with the European Directive 93/42/EEC | Change from baseline arterial tension to seven days after the intervention |