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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Other
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
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01869140