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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain
    • UCAM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; Bilateral vertebral manipulation of the T12-L1 vertebra	Other: Bilateral vertebral manipulation of the T12-L1 vertebra through manual therapy; Bilateral vertebral manipulation of the T12-L1 vertebra through manual therapy
PLACEBO_COMPARATOR: Placebo; Application of slight manual tension to the vertebra without reaching a manipulation thrust	Other: Placebo; Manual tension without reaching the manipulation "thrust"

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidad de Murcia
• Collaborators: UCAM university

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 4, 2022
• Primary Completion (ACTUAL): June 16, 2022
• Study Completion (ACTUAL): October 19, 2022

Study Registration Dates

• First Submitted: March 17, 2022
• First Submitted That Met QC Criteria: March 29, 2022
• First Posted (ACTUAL): April 7, 2022

Study Record Updates

• Last Update Posted (ACTUAL): December 1, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: FLM012022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No