Clinical trial NCT05315622: Effects of the T12-L1 Vertebral Manipulation on Body Temperature, Arterial Tension and Cardiac Frequency
Official title: Effects of the T12-L1 Vertebral Manipulation on Body Temperature, Arterial Tension and Cardiac Frequency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Spinal Manipulation
Manual Therapy
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
Collaborators: name: UCAM university
First posted: 2022-04-07
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blinded Randomized Controlled Trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Body temperature
timeFrame: Change from baseline Body Temperature to ten minutes after the intervention
measure: Body temperature
timeFrame: Change from baseline Body Temperature to seven days after the intervention
measure: Cardiac frequency
timeFrame: Change from baseline Cardiac Frequency to ten minutes after the intervention
measure: Cardiac frequency
timeFrame: Change from baseline Cardiac Frequency to seven days after the intervention
measure: Arterial tension
timeFrame: Change from baseline arterial tension to ten minutes after the intervention
measure: Arterial tension
timeFrame: Change from baseline arterial tension to seven days after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: UCAM
Study officials:
References: