Back to resultsAutonomic Effects of T4 Mobilization in Asymptomatic Subjects
Primary Purpose
Other Disorders of the Autonomic Nervous System, Vertebra; Degeneration
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Spinal mobilization
Spinal Mobilization II
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Other Disorders of the Autonomic Nervous System focused on measuring Autonomic effects, spinal mobilization, clinical trial
Eligibility Criteria
Inclusion Criteria:
- Asymptomatic subjects
- Aged between 18 - 40 years old
- Portuguese readers and writers
Exclusion Criteria:
- History of lesion or surgery to the spine
Sites / Locations
- Universidade Federal de Ciências da Saúde de Porto Alegre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Spinal mobilization
Spinal Mobilization II
Placebo
Arm Description
20 subjects will be randomized to this arm. A postero-anterior (PA) mobilization, to the fourth thoracic vertebra will be applied, for 3 sets of one minute. The subject will be comfortable prone lying.
20 subjects will be randomized to this arm. A postero-anterior (PA) mobilization, to the fourth thoracic vertebra will be applied, for 3 sets of one minute, but in this case, the subject will be seated, in a position that influence the sympathetic trunk, at the thorax.
20 subjects will be randomized to this arm. Only manual contact will be applied, without any oscillation. The subject will be comfortable prone lying. The intervention time is the same of the other arms.
Outcomes
Primary Outcome Measures
Skin conductance
Skin conductance will be measured with Biopac MP150, the electrodes will be attached to the third and fourth fingers bilaterally. This measurement will be made during all the procedure, before, during and until 15 minutes after the intervention.
Secondary Outcome Measures
Pressure pain threshold
Pressure pain threshold will be measured with a digital algometer (Model FDX 10; Wagner Instruments, Greenwich, CT). This measurement will be made on the spinous process of C5 and T4, on the first dorsal interossei, and on the anterior tibial tuberosity bilaterally.
Full Information
NCT ID
NCT02164123
First Posted
June 9, 2014
Last Updated
March 5, 2015
Sponsor
Federal University of Health Science of Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT02164123
Brief Title
Autonomic Effects of T4 Mobilization in Asymptomatic Subjects
Official Title
Autonomic Effects of T4 Mobilization in Asymptomatic Subjects: Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Health Science of Porto Alegre
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether passive accessory intervertebral mobilization applied to the fourth thoracic vertebra produces autonomic effects.
Detailed Description
Asymptomatic subjects will be recruited to this study. Pressure pain threshold, heart rate, heart rate variability and skin conductance will be measured before, immediately after and fifteen minutes after the intervention.
Subjects will be randomized into three groups: Passive accessory intervertebral mobilization one, passive accessory intervertebral mobilization two and placebo group.
The researcher that will do the intervention will be blinded to the outcomes measures, and the researcher that will do the measurements will be blind to the intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Other Disorders of the Autonomic Nervous System, Vertebra; Degeneration
Keywords
Autonomic effects, spinal mobilization, clinical trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Spinal mobilization
Arm Type
Experimental
Arm Description
20 subjects will be randomized to this arm. A postero-anterior (PA) mobilization, to the fourth thoracic vertebra will be applied, for 3 sets of one minute. The subject will be comfortable prone lying.
Arm Title
Spinal Mobilization II
Arm Type
Active Comparator
Arm Description
20 subjects will be randomized to this arm. A postero-anterior (PA) mobilization, to the fourth thoracic vertebra will be applied, for 3 sets of one minute, but in this case, the subject will be seated, in a position that influence the sympathetic trunk, at the thorax.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
20 subjects will be randomized to this arm. Only manual contact will be applied, without any oscillation. The subject will be comfortable prone lying. The intervention time is the same of the other arms.
Intervention Type
Other
Intervention Name(s)
Spinal mobilization
Other Intervention Name(s)
Postero-anterior spinal mobilization in prone
Intervention Description
Experimental group
Intervention Type
Other
Intervention Name(s)
Spinal Mobilization II
Other Intervention Name(s)
Postero-anterior spinal mobilization in seated position
Intervention Description
Active comparator group
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo technique, olny manual contact
Intervention Description
Placebo group
Primary Outcome Measure Information:
Title
Skin conductance
Description
Skin conductance will be measured with Biopac MP150, the electrodes will be attached to the third and fourth fingers bilaterally. This measurement will be made during all the procedure, before, during and until 15 minutes after the intervention.
Time Frame
Change from Baseline imediately after, and 15 minutes after the intervention
Secondary Outcome Measure Information:
Title
Pressure pain threshold
Description
Pressure pain threshold will be measured with a digital algometer (Model FDX 10; Wagner Instruments, Greenwich, CT). This measurement will be made on the spinous process of C5 and T4, on the first dorsal interossei, and on the anterior tibial tuberosity bilaterally.
Time Frame
Change from Baseline imediately after, and 15 minutes after the intervention
Other Pre-specified Outcome Measures:
Title
Heart rate variability
Description
Heart rate variability will be measured with a Polar Advantage Interface (Polar Electro Oy, Kempele, Finland). The belt will be positioned centrally, directly below the xiphisternum. Heart rate data acquisition will me made for 5 minutes at baseline and for 5 minutes immediately after the intervention.
Time Frame
Change from Baseline imediately after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Asymptomatic subjects
Aged between 18 - 40 years old
Portuguese readers and writers
Exclusion Criteria:
History of lesion or surgery to the spine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco De Araujo, Pt
Organizational Affiliation
Federal University of Health Science of Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal de Ciências da Saúde de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90050-170
Country
Brazil
12. IPD Sharing Statement
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Autonomic Effects of T4 Mobilization in Asymptomatic Subjects
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