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Trial record 1 of 1 for:    Effects of thoracic spine mobilization on sympathetic nervous systems
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Effect of Thoracic Spine Mobilization on Sympathetic Nervous Systems

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ClinicalTrials.gov Identifier: NCT02832141
Recruitment Status : Completed
First Posted : July 14, 2016
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Slavko Rogan, Bern University of Applied Sciences

Brief 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.

Condition or disease Intervention/treatment
Erythema Procedure: Mobilization anterior Procedure: Mobilization posterior

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Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Effect of Thoracic Spine Mobilization on Skin-blood Flow, Erythema and Sympathetic Nervous Systems
Actual Study Start Date : May 2016
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Group/Cohort Intervention/treatment
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.
Procedure: Mobilization anterior
Participant in prone position. Central thoracic mobilization from posterior-to-anterior.
Other Name: Thoracic spine mobilization with anterior pressure

Procedure: Mobilization posterior
Participant in sitting position. Central thoracic mobilization from anteriors-to-posterior.
Other Name: Thoracic spine mobilization with posterior pressure

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.
Procedure: Mobilization anterior
Participant in prone position. Central thoracic mobilization from posterior-to-anterior.
Other Name: Thoracic spine mobilization with anterior pressure

Procedure: Mobilization posterior
Participant in sitting position. Central thoracic mobilization from anteriors-to-posterior.
Other Name: Thoracic spine mobilization with posterior pressure




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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.


Secondary Outcome Measures :
  1. Rate of heart rate variability (HRV) [ Time Frame: Change from baseline imediately after, 2, 4, 6, 8 and 10 minutes after the intervention ]
    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)

  2. Rate of systolic blood pressure value (mmHg) [ Time Frame: Change from baseline imediately after, 2, 4, 6, 8 and 10 minutes after the intervention ]
    Omron MIT Elite Plus is used for measuring systolic blood flow. iMeasurement units: mmHg (millimeter of mercury)

  3. 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 ]
    Omron MIT Elite Plus is used for measuring diastolic blood pressureMeasurement units: mmHg (millimeter of mercury)

  4. Rate of heartbeat frequency [ Time Frame: Change from baseline imediately after, 2, 4, 6, 8 and 10 minutes after the intervention ]
    Polar watch RS800 is used for measuring heartbeat frequency. Measurement units: beat per minute (bpm)

  5. Rate of skin-blood flow variation [ Time Frame: Change from baseline imediately after, 2, 4, 6, 8 and 10 minutes after the intervention ]
    Laser doppler imaging is used for measuring microcirculatory changes. Measurement units: perfusion unit

  6. Rate of erythema [ Time Frame: Change from baseline imediately after, 2, 4, 6, 8 and 10 minutes after the intervention ]
    Tristimulus surface colorimetry is used for measuring erythema. Measurement units: Erythema index



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy person between 20 and 30 years.
Criteria

Inclusion Criteria:

  • age 20 - 30 years
  • healthy persons

Exclusion Criteria:

  • current pain
  • blood pressure medications
  • osteoporosis
  • cardiac or neurological symptoms
  • pregnancy
  • thromobosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02832141


Locations
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Switzerland
Bern University of Applied Science, Department Health
Bern, Switzerland, 3008
Sponsors and Collaborators
Bern University of Applied Sciences
Investigators
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Principal Investigator: Jan Taeymans, PhD Bern University of Applied Science, Departement Health

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Slavko Rogan, MSc, MA, Bern University of Applied Sciences
ClinicalTrials.gov Identifier: NCT02832141    
Other Study ID Numbers: Mobilization Thoracic Spine
First Posted: July 14, 2016    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Slavko Rogan, Bern University of Applied Sciences:
Skin blood flow
Skin redness
Sympathetic nervous system
Regional Blood Flow
Additional relevant MeSH terms:
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Erythema
Skin Diseases
Skin Manifestations
Signs and Symptoms