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NCT02832141 Clinical Trial

Effect of Thoracic Spine Mobilization on Sympathetic Nervous Systems

Erythema Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02832141
Other study ID # Mobilization Thoracic Spine
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2016
Est. completion date December 31, 2018

Study information
Verified date January 2019
Source Bern University of Applied Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

Recruitment information / eligibility
Status Completed
Enrollment 14
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 30 Years
Eligibility Inclusion Criteria:

- age 20 - 30 years

- healthy persons

Exclusion Criteria:

- current pain

- blood pressure medications

- osteoporosis

- cardiac or neurological symptoms

- pregnancy

- thromobosis

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Mobilization anterior
Participant in prone position. Central thoracic mobilization from posterior-to-anterior.
• Mobilization posterior
Participant in sitting position. Central thoracic mobilization from anteriors-to-posterior.

Locations
Country Name City State
Switzerland Bern University of Applied Science, Department Health Bern

Sponsors (1)
Lead Sponsor Collaborator
Bern University of Applied Sciences

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Feasibility: Adherence of recruited participants Defined as the number of drop-outs and presence of participants which invited. Measurement unit: number Every 4 weeks up to 2 years
Primary Feasibility of the investigating procedure Measured the burden of testing procedure. Measurement units = number and percentage Every 4 weeks up to 2 years
Primary 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 Every 4 weeks up to 2 years
Primary 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. Every 4 weeks up to 2 years
Secondary 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) Change from baseline imediately after, 2, 4, 6, 8 and 10 minutes after the intervention
Secondary Rate of systolic blood pressure value (mmHg) Omron MIT Elite Plus is used for measuring systolic blood flow. iMeasurement units: mmHg (millimeter of mercury) Change from baseline imediately after, 2, 4, 6, 8 and 10 minutes after the intervention
Secondary Rate of diastolic blood pressure value (mmHg) changes Omron MIT Elite Plus is used for measuring diastolic blood pressureMeasurement units: mmHg (millimeter of mercury) Change from baseline imediately after, 2, 4, 6, 8 and 10 minutes after the intervention
Secondary Rate of heartbeat frequency Polar watch RS800 is used for measuring heartbeat frequency. Measurement units: beat per minute (bpm) Change from baseline imediately after, 2, 4, 6, 8 and 10 minutes after the intervention
Secondary Rate of skin-blood flow variation Laser doppler imaging is used for measuring microcirculatory changes. Measurement units: perfusion unit Change from baseline imediately after, 2, 4, 6, 8 and 10 minutes after the intervention
Secondary Rate of erythema Tristimulus surface colorimetry is used for measuring erythema. Measurement units: Erythema index Change from baseline imediately after, 2, 4, 6, 8 and 10 minutes after the intervention
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