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

Not Applicable

Completed

• Conditions: Healthy Subjects; Spinal Manipulation; Manual Therapy
• Interventions: Other: Placebo; Other: Bilateral vertebral manipulation of the T12-L1 vertebra through manual therapy

• Registration Number: NCT05315622
• Lead Sponsor: Universidad de Murcia

Brief Summary

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

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.

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-17
• Study First Submitted QC: 2022-03-29
• Study Start: 2022-04-04
• Study First Posted: 2022-04-07
• Primary Completion: 2022-06-16
• Study Completion: 2022-10-19
• Last Update Submitted: 2022-11-28
• Last Update Posted: 2022-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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.

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Exclusion Criteria

• Surgical intervention in the 5 years previous to the study;
• Any acute or chronic medical condition;
• Any pharmacological treatment;
• Osteosynthetic implants.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Application of slight manual tension to the vertebra without reaching a manipulation thrust
Intervention	Bilateral vertebral manipulation of the T12-L1 vertebra through manual therapy	Bilateral vertebral manipulation of the T12-L1 vertebra

Primary Outcome Measures

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

Trial Locations

Locations (1)

UCAM; 🇪🇸 Murcia, Spain