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Completed

NCT Number: NCT02832141

Effect of Thoracic Spine Mobilization on 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.

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Key information

Conditions

Erythema Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases

Age range

20 year–30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bern University of Applied Science, Department Health

Bern, 3008, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 20 - 30 years
  • healthy persons

Exclusion criteria

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

Treatment and study plan

Mobilization anterior

Procedure

Participant in prone position. Central thoracic mobilization from posterior-to-anterior.

Other names: Thoracic spine mobilization with anterior pressure

Mobilization posterior

Procedure

Participant in sitting position. Central thoracic mobilization from anteriors-to-posterior.

Other names: Thoracic spine mobilization with posterior pressure

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bern University of Applied Sciences

Other

Registry information

Official study title

Effect of Thoracic Spine Mobilization on Skin-blood Flow, Erythema and Sympathetic Nervous Systems

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 14, 2016
Registry last updated
Jan 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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