the Hypoalgesic Effect of Spinal Manual Therapy
Primary Purpose
Back Pain
Status
Unknown status
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
spinal manual therapy
Sponsored by
About this trial
This is an interventional basic science trial for Back Pain
Eligibility Criteria
Inclusion Criteria:
Healthy Students who volunteer from Murdoch University
-
Exclusion Criteria:
- contraindication to spinal manual therapy
Sites / Locations
- Murdoch University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Sham Comparator
Experimental
Experimental
Arm Label
sham spinal manual therapy
percussive spinal manual therapy
Firm thoracic spinal manual therapy
Arm Description
activator set to zero
activator set to the maximum force
Firm thoracic manipulation
Outcomes
Primary Outcome Measures
the Pressure pain threshold in KPa/Cm2 will be measure with an Algometer (SOMEDIC)
Secondary Outcome Measures
Full Information
NCT ID
NCT01869140
First Posted
May 17, 2013
Last Updated
October 4, 2013
Sponsor
Institut Franco Europeen de Chiropratique
1. Study Identification
Unique Protocol Identification Number
NCT01869140
Brief Title
the Hypoalgesic Effect of Spinal Manual Therapy
Official Title
the Hypoalgesic Effect of Spinal Manual Therapy on an Healthy Population: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
May 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut Franco Europeen de Chiropratique
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To study the immediate effect of spinal manual therapy on pain perception in normal subjects
Detailed Description
Is this effect only local or is it also noticed away from the stimulated area? How long does it last? Is there a dose/response phenomenon?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
sham spinal manual therapy
Arm Type
Sham Comparator
Arm Description
activator set to zero
Arm Title
percussive spinal manual therapy
Arm Type
Experimental
Arm Description
activator set to the maximum force
Arm Title
Firm thoracic spinal manual therapy
Arm Type
Experimental
Arm Description
Firm thoracic manipulation
Intervention Type
Device
Intervention Name(s)
spinal manual therapy
Other Intervention Name(s)
activator
Intervention Description
spinal manipulation either manual or instrumental (activator)
Primary Outcome Measure Information:
Title
the Pressure pain threshold in KPa/Cm2 will be measure with an Algometer (SOMEDIC)
Time Frame
the pressure pain threshold will be measure immediately after intervention and every 15 minutes during 1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy Students who volunteer from Murdoch University
-
Exclusion Criteria:
contraindication to spinal manual therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yannick audo, PhD student
Organizational Affiliation
Institut Franco Europeen de Chiropratique
Official's Role
Principal Investigator
Facility Information:
Facility Name
Murdoch University
City
Perth
State/Province
Western Australia
Country
Australia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruce Walker, PhD MPH
Phone
0033677500657
Email
B.walker@murdoch.edu.au
First Name & Middle Initial & Last Name & Degree
Bruce Walker, PhD, MPH
12. IPD Sharing Statement
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the Hypoalgesic Effect of Spinal Manual Therapy
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