NCT02832141

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 14, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

January 29, 2019

Status Verified

January 1, 2019

Enrollment Period

2.7 years

First QC Date

July 2, 2016

Last Update Submit

January 28, 2019

Conditions

Keywords

Skin blood flowSkin rednessSympathetic nervous systemRegional Blood Flow

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (6)

  • Rate of heart rate variability (HRV)

    Change from baseline imediately after, 2, 4, 6, 8 and 10 minutes after the intervention

  • Rate of systolic blood pressure value (mmHg)

    Change from baseline imediately after, 2, 4, 6, 8 and 10 minutes after the intervention

  • Rate of diastolic blood pressure value (mmHg) changes

    Change from baseline imediately after, 2, 4, 6, 8 and 10 minutes after the intervention

  • Rate of heartbeat frequency

    Change from baseline imediately after, 2, 4, 6, 8 and 10 minutes after the intervention

  • Rate of skin-blood flow variation

    Change from baseline imediately after, 2, 4, 6, 8 and 10 minutes after the intervention

  • +1 more secondary outcomes

Study Arms (2)

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 anteriorProcedure: Mobilization posterior

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 anteriorProcedure: Mobilization posterior

Interventions

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

Also known as: Thoracic spine mobilization with anterior pressure
Group AGroup B

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

Also known as: Thoracic spine mobilization with posterior pressure
Group AGroup B

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Healthy person between 20 and 30 years.

You may qualify if:

  • age 20 - 30 years
  • healthy persons

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bern University of Applied Science, Department Health

Bern, 3008, Switzerland

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Erythema

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jan Taeymans, PhD

    Bern University of Applied Science, Departement Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc, MA

Study Record Dates

First Submitted

July 2, 2016

First Posted

July 14, 2016

Study Start

May 1, 2016

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

January 29, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations