Healthy SubjectsNCT05315622
Effects of the T12-L1 Vertebral Manipulation on Body Temperature, Arterial Tension and Cardiac Frequency
A study testing Bilateral vertebral manipulation of the T12-L1 vertebra through manual therapy in people with Healthy Subjects and Spinal Manipulation, run by Universidad de Murcia at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, Spinal Manipulation, Manual Therapy
- What is being tested?
- Bilateral vertebral manipulation of the T12-L1 vertebra through manual therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 1 siteSpain
- Study dates
- 4 Apr 2022to 19 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Surgical intervention in the 5 years previous to the study;
- Any acute or chronic medical condition;
- Any pharmacological treatment;
- Osteosynthetic implants.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Healthy Subjects, Spinal Manipulation, Manual Therapy
- Being tested
- Bilateral vertebral manipulation of the T12-L1 vertebra through manual therapy, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral vertebral manipulation of the T12-L1 vertebra through manual therapyOther
Bilateral vertebral manipulation of the T12-L1 vertebra through manual therapy
PlaceboOther
Manual tension without reaching the manipulation "thrust"
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Bilateral vertebral manipulation of the T12-L1 vertebra Receives: 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 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body temperature
Body temperature: Celsius degree will be measured by means of a digital thermometer
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Change from baseline arterial tension to seven days after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start4 Apr 2022
- Primary completion16 Jun 2022
- Study completion19 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blinded Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Collaborators
- UCAM university
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315622
- Sponsor's protocol ID
- FLM012022
- Status last verified
- Mar 2022
- First submitted
- 17 Mar 2022
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the T12-L1 Vertebral Manipulation on Body Temperature, Arterial Tension and Cardiac Frequency
- ClinicalTrials.gov ID
- NCT05315622
- Acronym / sponsor ID
- FLM012022
- Conditions
- Healthy Subjects, Spinal Manipulation, Manual Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Collaborators
- UCAM university
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 16 Jun 2022 (actual)
- Study completion
- 19 Oct 2022 (actual)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single-blinded Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Bilateral vertebral manipulation of the T12-L1 vertebra through manual therapyBilateral vertebral manipulation of the T12-L1 vertebra |
| Placebo | Placebo comparator | Other: PlaceboApplication of slight manual tension to the vertebra without reaching a manipulation thrust |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Surgical intervention in the 5 years previous to the study;
- Any acute or chronic medical condition;
- Any pharmacological treatment;
- Osteosynthetic implants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral vertebral manipulation of the T12-L1 vertebra through manual therapyBilateral vertebral manipulation of the T12-L1 vertebra through manual therapy | Other | Intervention |
| PlaceboManual tension without reaching the manipulation "thrust" | Other | Placebo |
Primary outcome
Body temperature
Time frame: Change from baseline Body Temperature to ten minutes after the intervention
Body temperature: Celsius degree will be measured by means of a digital thermometer
Body temperature
Time frame: Change from baseline Body Temperature to seven days after the intervention
Body temperature: Celsius degree will be measured by means of a digital thermometer
Cardiac frequency
Time frame: 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
Cardiac frequency
Time frame: 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
Arterial tension
Time frame: 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
Arterial tension
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral vertebral manipulation of the T12-L1 vertebra through manual therapy in people with Healthy Subjects and Spinal Manipulation, run by Universidad de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body temperature (time frame: Change from baseline Body Temperature to ten minutes after the intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2022.