Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01869140




Registration number
NCT01869140
Ethics application status
Date submitted
17/05/2013
Date registered
5/06/2013
Date last updated
8/10/2013

Titles & IDs
Public title
the Hypoalgesic Effect of Spinal Manual Therapy
Scientific title
the Hypoalgesic Effect of Spinal Manual Therapy on an Healthy Population: a Randomized Clinical Trial
Secondary ID [1] 0 0
IFEC-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Back Pain 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - spinal manual therapy

Sham Comparator: sham spinal manual therapy - activator set to zero

Experimental: percussive spinal manual therapy - activator set to the maximum force

Experimental: Firm thoracic spinal manual therapy - Firm thoracic manipulation


Treatment: Devices: spinal manual therapy
spinal manipulation either manual or instrumental (activator)
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
the Pressure pain threshold in KPa/Cm2 will be measure with an Algometer (SOMEDIC)
Timepoint [1] 0 0
the pressure pain threshold will be measure immediately after intervention and every 15 minutes during 1 hour

Eligibility
Key inclusion criteria
Healthy Students who volunteer from Murdoch University

-
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- contraindication to spinal manual therapy

Study design
Purpose of the study
Basic Science
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2014
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Murdoch University - Perth
Recruitment postcode(s) [1] 0 0
- Perth

Funding & Sponsors
Primary sponsor type
Other
Name
Institut Franco Europeen de Chiropratique
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To study the immediate effect of spinal manual therapy on pain perception in normal subjects
Trial website
https://clinicaltrials.gov/ct2/show/NCT01869140
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
yannick audo, PhD student
Address 0 0
Institut Franco Europeen de Chiropratique
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01869140