ErythemaNCT02832141
Effect of Thoracic Spine Mobilization on Sympathetic Nervous Systems
An observational study of Erythema, run by Bern University of Applied Sciences at 1 site in Switzerland.
Trial summary
This pilot study aims to i) represents the feasibility of the study design and ii) to point out acute effects of thoracic spine mobilization on skin-blood flow, erythema and the sympathetic nervous system. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Erythema
- What is being tested?
- Mobilization anterior and Mobilization posterior
- Type of treatment
- Surgery or procedure
- How many people
- 14 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2016to 31 Dec 2018
- Phase
- Observational
- 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 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy person between 20 and 30 years.
Who may be able to join
- age 20 - 30 years
- healthy persons
Who cannot join
- current pain
- blood pressure medications
- osteoporosis
- cardiac or neurological symptoms
- pregnancy
- thromobosis
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Bern University of Applied Science, Department Health
Bern, 3008
About this study
Official title: Effect of Thoracic Spine Mobilization on Skin-blood Flow, Erythema and Sympathetic Nervous Systems
This pilot study aims to i) represents the feasibility of the study design and ii) to point out acute effects of thoracic spine mobilization on skin-blood flow, erythema and the sympathetic nervous system.
- Conditions
- Erythema
- Being tested
- Mobilization anterior, Mobilization posterior
- Keywords
- Skin blood flow, Skin redness, Sympathetic nervous system, Regional Blood Flow
- Medical subject headings
- Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobilization anteriorProcedure or surgery
Also called Thoracic spine mobilization with anterior pressure
Participant in prone position. Central thoracic mobilization from posterior-to-anterior.
Mobilization posteriorProcedure or surgery
Also called Thoracic spine mobilization with posterior pressure
Participant in sitting position. Central thoracic mobilization from anteriors-to-posterior.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Group A: immediate effects: T0, Grade 3 central thoracic mobilization from posterior-to-anterior on thoracic vertebrae from T5 to T12, immediate (T1), after 2 (T2), 4 (T3), 6 (T4), 8 (T5) and 10 (T6) minutes, 1 days wash-out period; T7, a grade 3 central thoracic mobilization from anterior-to-posterior on all thoracic vertebrae, immediate T8, after 2 (T9), 4 (T10), 6 (T11), 8 (T12) and 10 (T13) minutes. Receives: Procedure: Mobilization anterior; Procedure: Mobilization posterior | |
| Group B | Group B: immediate effects: T0, 3 central thoracic mobilization from anterior-to-posterior on thoracic vertebrae from T5 to T12, immediate (T1), after 2 (T2), 4 (T3), 6 (T4), 8 (T5) and 10 (T6) minutes, 1 days wash-out period; T7, a grade 3-4 central thoracic mobilization from posterior-to-anterior on all thoracic vertebrae, immediate T8, after 2 (T9), 4 (T10), 6 (T11), 8 (T12) and 10 (T13) minutes. Receives: Procedure: Mobilization anterior; Procedure: Mobilization posterior |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Adherence of recruited participants
Defined as the number of drop-outs and presence of participants which invited. Measurement unit: number
Measured: Every 4 weeks up to 2 years
Feasibility of the investigating procedure
Measured the burden of testing procedure. Measurement units = number and percentage
Measured: Every 4 weeks up to 2 years
Feasibility of the mobilization intervention from posterior-to-anterior on thoracic vertebrae
Measured adverse effects as pain and harm results to participants. Measurement units = number and percentage
Measured: Every 4 weeks up to 2 years
Feasibility of the mobilization intervention from anterior-to-posterior on thoracic vertebrae
Measured as adverse effects as pain and harm results to participants. Measurement units = number and percentage.
Measured: Every 4 weeks up to 2 years
Secondary outcomes (6)
Rate of heart rate variability (HRV)
HRV is measured as the variations of the time interval between two consecutive cardiac beats registered by means Polar watch RS800 is used to measures (HRV). Measurement unit: High frequency-band (HF-Band) and Low frequency-band (LF-Band)
Measured: Change from baseline imediately after, 2, 4, 6, 8 and 10 minutes after the intervention
Rate of systolic blood pressure value (mmHg)
Omron MIT Elite Plus is used for measuring systolic blood flow. iMeasurement units: mmHg (millimeter of mercury)
Measured: Change from baseline imediately after, 2, 4, 6, 8 and 10 minutes after the intervention
Rate of diastolic blood pressure value (mmHg) changes
Omron MIT Elite Plus is used for measuring diastolic blood pressureMeasurement units: mmHg (millimeter of mercury)
Measured: Change from baseline imediately after, 2, 4, 6, 8 and 10 minutes after the intervention
Rate of heartbeat frequency
Polar watch RS800 is used for measuring heartbeat frequency. Measurement units: beat per minute (bpm)
Measured: Change from baseline imediately after, 2, 4, 6, 8 and 10 minutes after the intervention
Rate of skin-blood flow variation
Laser doppler imaging is used for measuring microcirculatory changes. Measurement units: perfusion unit
Measured: Change from baseline imediately after, 2, 4, 6, 8 and 10 minutes after the intervention
Rate of erythema
Tristimulus surface colorimetry is used for measuring erythema. Measurement units: Erythema index
Measured: Change from baseline imediately after, 2, 4, 6, 8 and 10 minutes 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 posted14 Jul 2016 (estimated)
- Study startMay 2016
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ErythemaStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bern University of Applied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Slavko Rogan, Bern University of Applied Sciences
- Investigators
- Jan Taeymans, PhD, Principal investigator, Bern University of Applied Science, Departement Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832141
- Sponsor's protocol ID
- Mobilization Thoracic Spine
- Status last verified
- Jan 2019
- First submitted
- 2 Jul 2016
- Last updated
- 29 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Rogan S, Taeymans J, Clarys P, Clijsen R, Tal-Akabi A. Feasibility and effectiveness of thoracic spine mobilization on sympathetic/parasympathetic balance in a healthy population - a randomized controlled double-blinded pilot study. Arch Physiother. 2019 Dec 9;9:15. doi: 10.1186/s40945-019-0067-2. eCollection 2019.
PubMed 31867125
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Thoracic Spine Mobilization on Skin-blood Flow, Erythema and Sympathetic Nervous Systems
- ClinicalTrials.gov ID
- NCT02832141
- Acronym / sponsor ID
- Mobilization Thoracic Spine
- Conditions
- Erythema
- Keywords
- Skin blood flow, Skin redness, Sympathetic nervous system, Regional Blood Flow
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Bern University of Applied SciencesUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 14 Jul 2016 (estimated)
- 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.
This pilot study aims to i) represents the feasibility of the study design and ii) to point out acute effects of thoracic spine mobilization on skin-blood flow, erythema and the sympathetic nervous system.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Procedure: Mobilization anterior, Procedure: Mobilization posteriorGroup A: immediate effects: T0, Grade 3 central thoracic mobilization from posterior-to-anterior on thoracic vertebrae from T5 to T12, immediate (T1), after 2 (T2), 4 (T3), 6 (T4), 8 (T5) and 10 (T6) minutes, 1 days wash-out period; T7, a grade 3 central thoracic mobilization from anterior-to-posterior on all thoracic vertebrae, immediate T8, after 2 (T9), 4 (T10), 6 (T11), 8 (T12) and 10 (T13) minutes. |
| Group B | – | Procedure: Mobilization anterior, Procedure: Mobilization posteriorGroup B: immediate effects: T0, 3 central thoracic mobilization from anterior-to-posterior on thoracic vertebrae from T5 to T12, immediate (T1), after 2 (T2), 4 (T3), 6 (T4), 8 (T5) and 10 (T6) minutes, 1 days wash-out period; T7, a grade 3-4 central thoracic mobilization from posterior-to-anterior on all thoracic vertebrae, immediate T8, after 2 (T9), 4 (T10), 6 (T11), 8 (T12) and 10 (T13) minutes. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy person between 20 and 30 years.
Key inclusion criteria (2 listed)
- age 20 - 30 years
- healthy persons
Key exclusion criteria (6 listed)
- current pain
- blood pressure medications
- osteoporosis
- cardiac or neurological symptoms
- pregnancy
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 |
|---|---|---|
| Mobilization anteriorAlso: Thoracic spine mobilization with anterior pressureParticipant in prone position. Central thoracic mobilization from posterior-to-anterior. | Procedure or surgery | Group A, Group B |
| Mobilization posteriorAlso: Thoracic spine mobilization with posterior pressureParticipant in sitting position. Central thoracic mobilization from anteriors-to-posterior. | Procedure or surgery | Group A, Group B |
Primary outcome
Feasibility: Adherence of recruited participants
Time frame: Every 4 weeks up to 2 years
Defined as the number of drop-outs and presence of participants which invited. Measurement unit: number
Feasibility of the investigating procedure
Time frame: Every 4 weeks up to 2 years
Measured the burden of testing procedure. Measurement units = number and percentage
Feasibility of the mobilization intervention from posterior-to-anterior on thoracic vertebrae
Time frame: Every 4 weeks up to 2 years
Measured adverse effects as pain and harm results to participants. Measurement units = number and percentage
Feasibility of the mobilization intervention from anterior-to-posterior on thoracic vertebrae
Time frame: Every 4 weeks up to 2 years
Measured as adverse effects as pain and harm results to participants. Measurement units = number and percentage.
6 secondary outcomes
Rate of heart rate variability (HRV)
Time frame: Change from baseline imediately after, 2, 4, 6, 8 and 10 minutes after the intervention
Rate of systolic blood pressure value (mmHg)
Time frame: Change from baseline imediately after, 2, 4, 6, 8 and 10 minutes after the intervention
Rate of diastolic blood pressure value (mmHg) changes
Time frame: Change from baseline imediately after, 2, 4, 6, 8 and 10 minutes after the intervention
Rate of heartbeat frequency
Time frame: Change from baseline imediately after, 2, 4, 6, 8 and 10 minutes after the intervention
Rate of skin-blood flow variation
Time frame: Change from baseline imediately after, 2, 4, 6, 8 and 10 minutes after the intervention
Rate of erythema
Time frame: Change from baseline imediately after, 2, 4, 6, 8 and 10 minutes after the intervention
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 29 Jan 2019.
- Derived from this study: PubMed 31867125Rogan S, Taeymans J, Clarys P, Clijsen R, Tal-Akabi A. Feasibility and effectiveness of thoracic spine mobilization on sympathetic/parasympathetic balance in a healthy population - a randomized controlled double-blinded pilot study. Arch Physiother. 2019 Dec 9;9:15. doi: 10.1186/s40945-019-0067-2. eCollection 2019.
- Individual participant dataSharing planned: No
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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.
Jan Taeymans, PhD principal investigator
Bern University of Applied Science, Departement Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Erythema, run by Bern University of Applied Sciences at 1 site in Switzerland.
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 2 inclusion and 6 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 29 Jan 2019. 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 Switzerland. 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. 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?
Feasibility: Adherence of recruited participants (time frame: Every 4 weeks up to 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02832141, which also lists 1 linked publication.
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 29 Jan 2019.