Effect of Thoracic Spine Mobilization on Sympathetic Nervous Systems

Completed

• Conditions: Erythema
• Interventions: Procedure: Mobilization anterior; Procedure: Mobilization posterior

• Registration Number: NCT02832141
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-07-02
• Study First Submitted QC: 2016-07-11
• Study First Posted: 2016-07-14
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-28
• Last Update Posted: 2019-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• age 20 - 30 years
• healthy persons

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A	Mobilization anterior	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.
Group A	Mobilization posterior	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.
Group B	Mobilization anterior	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.
Group B	Mobilization posterior	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.

Primary Outcome Measures

Name	Time	Method
Feasibility of the mobilization intervention from posterior-to-anterior on thoracic vertebrae	Every 4 weeks up to 2 years	Measured adverse effects as pain and harm results to participants. Measurement units = number and percentage
Feasibility: Adherence of recruited participants	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	Every 4 weeks up to 2 years	Measured the burden of testing procedure. Measurement units = number and percentage
Feasibility of the mobilization intervention from anterior-to-posterior on thoracic vertebrae	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

Name	Time	Method
Rate of heartbeat frequency	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)
Rate of heart rate variability (HRV)	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)
Rate of systolic blood pressure value (mmHg)	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)
Rate of diastolic blood pressure value (mmHg) changes	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)
Rate of skin-blood flow variation	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
Rate of erythema	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

Trial Locations

Locations (1)

Bern University of Applied Science, Department Health; 🇨🇭 Bern, Switzerland