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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05315622
• Other study ID #: FLM012022
• Status: Completed
• Phase: N/A
• Start date: April 4, 2022
• Est. completion date: October 19, 2022

Study information

• Verified date: March 2022
• Source: Universidad de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: October 19, 2022
• Est. primary completion date: June 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subjects
• Manual Therapy
• Spinal Manipulation

Intervention

Other:
• Bilateral vertebral manipulation of the T12-L1 vertebra through manual therapy
Bilateral vertebral manipulation of the T12-L1 vertebra through manual therapy
• Placebo
Manual tension without reaching the manipulation "thrust"

Locations

Country	Name	City	State
Spain	UCAM	Murcia

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Murcia	UCAM university

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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