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

• Sponsor: Universidad de Murcia (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05315622
• Collaborator: UCAM university (Other)
• Enrollment: 40
• Arms: 2
• Anticipated Duration (Months): 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects; Spinal Manipulation; Manual Therapy	Other: Bilateral vertebral manipulation of the T12-L1 vertebra through manual therapy; Other: Placebo	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Single-blinded Randomized Controlled TrialSingle-blinded Randomized Controlled Trial
• Masking: Single (Participant)
• Masking Description: Participants will be unaware of their group assignment
• Primary Purpose: Treatment
• Official Title: Effects of the T12-L1 Vertebral Manipulation on Body Temperature, Arterial Tension and Cardiac Frequency
• Anticipated Study Start Date: Apr 1, 2022
• Anticipated Primary Completion Date: Jun 1, 2022
• Anticipated Study Completion Date: Jul 1, 2022

Arms and Interventions

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"

Outcome Measures

Primary Outcome Measures

1. Body temperature [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 [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 [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 [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 [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Universidad de Murcia
• UCAM university

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Universidad de Murcia
• ClinicalTrials.gov Identifier: NCT05315622
• Other Study ID Numbers: FLM012022
• First Posted: Apr 7, 2022
• Last Update Posted: Apr 7, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Apr 7, 2022