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Completed

NCT Number: NCT05315622

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

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.

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Key information

Conditions

Healthy Subjects Manual Therapy Spinal Manipulation

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCAM

Murcia, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bilateral vertebral manipulation of the T12-L1 vertebra through manual therapy

Other

Bilateral vertebral manipulation of the T12-L1 vertebra through manual therapy

Placebo

Other

Manual tension without reaching the manipulation "thrust"

Primary outcomes

  1. Body temperature

    Time frame: Change from baseline Body Temperature to ten minutes after the intervention

    Body temperature: Celsius degree will be measured by means of a digital thermometer

  2. Body temperature

    Time frame: Change from baseline Body Temperature to seven days after the intervention

    Body temperature: Celsius degree will be measured by means of a digital thermometer

  3. Cardiac frequency

    Time frame: Change from baseline Cardiac Frequency to ten minutes 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

  4. Cardiac frequency

    Time frame: 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

  5. Arterial tension

    Time frame: Change from baseline arterial tension to ten minutes 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

  6. Arterial tension

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Universidad de Murcia

Other

Collaborators

  • UCAM university

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 7, 2022
Registry last updated
Dec 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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