Effect of Thoracic Spine Mobilization on Sympathetic Nervous Systems

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.

Study Overview

• Status: Completed
• Conditions: Erythema
• Intervention / Treatment: Procedure: Mobilization anterior; Procedure: Mobilization posterior

• Study Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3008
    • Bern University of Applied Science, Department Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 30 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Healthy person between 20 and 30 years.

Description

Inclusion Criteria:

• age 20 - 30 years
• healthy persons

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Feasibility of the investigating procedure	Measured the burden of testing procedure. Measurement units = number and percentage	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	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.	Every 4 weeks up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Bern University of Applied Sciences
• Investigators: Principal Investigator: Jan Taeymans, PhD, Bern University of Applied Science, Departement Health

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2016
• Primary Completion (ACTUAL): December 31, 2018
• Study Completion (ACTUAL): December 31, 2018

Study Registration Dates

• First Submitted: July 2, 2016
• First Submitted That Met QC Criteria: July 11, 2016
• First Posted (ESTIMATE): July 14, 2016

Study Record Updates

• Last Update Posted (ACTUAL): January 29, 2019
• Last Update Submitted That Met QC Criteria: January 28, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Skin blood flow; Regional Blood Flow; Sympathetic nervous system; Skin redness
• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Erythema
• Other Study ID Numbers: Mobilization Thoracic Spine

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO