Clincosm LogoSign in Get a demo

Effect of Thoracic Spine Mobilization on Sympathetic Nervous Systems

Sponsor
Bern University of Applied Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT02832141
Collaborator
(none)
14
Enrollment
1
Location
32
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Procedure: Mobilization anterior
  • Procedure: Mobilization posterior

Study Design

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 1, 2016
Actual Primary Completion Date :
Dec 31, 2018
Actual Study Completion Date :
Dec 31, 2018

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. Feasibility of the investigating procedure [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 [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 [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) [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) [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 [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 [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 [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 [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 30 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • age 20 - 30 years

    • healthy persons

    Exclusion Criteria:

    • current pain

    • blood pressure medications

    • osteoporosis

    • cardiac or neurological symptoms

    • pregnancy

    • thromobosis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bern University of Applied Science, Department Health Bern Switzerland 3008

    Sponsors and Collaborators

    • Bern University of Applied Sciences

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Slavko Rogan, MSc, MA, Bern University of Applied Sciences
    ClinicalTrials.gov Identifier:
    NCT02832141
    Other Study ID Numbers:
    • Mobilization Thoracic Spine
    First Posted:
    Jul 14, 2016
    Last Update Posted:
    Jan 29, 2019
    Last Verified:
    Jan 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Slavko Rogan, MSc, MA, Bern University of Applied Sciences
    Skin blood flow
    Skin redness
    Sympathetic nervous system
    Regional Blood Flow
    Additional relevant MeSH terms:
    Erythema

    Study Results

    No Results Posted as of Jan 29, 2019