Effect of Thoracic Spine Mobilization on Sympathetic Nervous Systems
1 other identifier
observational
14
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2016
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 2, 2016
CompletedFirst Posted
Study publicly available on registry
July 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedJanuary 29, 2019
January 1, 2019
2.7 years
July 2, 2016
January 28, 2019
Conditions
Keywords
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.
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.
Interventions
Participant in prone position. Central thoracic mobilization from posterior-to-anterior.
Participant in sitting position. Central thoracic mobilization from anteriors-to-posterior.
Eligibility Criteria
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
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.
PMID: 31867125DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jan Taeymans, PhD
Bern University of Applied Science, Departement Health
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