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

NCT05315622 | Completed

• 1 other identifier: FLM012022
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects; Spinal Manipulation; Manual Therapy

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

Bilateral vertebral manipulation of the T12-L1 vertebra

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

Placebo

PLACEBO COMPARATOR

Application of slight manual tension to the vertebra without reaching a manipulation thrust

Other: Placebo

Interventions

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

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

Intervention

Placebo OTHER

Manual tension without reaching the manipulation "thrust"

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de Murcia: lead
• UCAM university: collaborator

Study Sites (1)

UCAM

Murcia, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be unaware of their group assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-blinded Randomized Controlled Trial

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: April 7, 2022
• Study Start: April 4, 2022
• Primary Completion: June 16, 2022
• Study Completion: October 19, 2022
• Last Updated: December 1, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)