Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000809831
Ethics application status
Approved
Date submitted
22/07/2012
Date registered
2/08/2012
Date last updated
6/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of the dog technique to T4 in bilateral extension dysfunction in median neurodynamic test in patients with whiplash
Scientific title
Will T4 Dog technique produce changes in median neurodynamic test in patients with whiplash
Secondary ID [1] 280892 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
whiplash disorders 286965 0
Condition category
Condition code
Musculoskeletal 287302 287302 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
we make a dog technique osteopathic manipulation once in T4
trying to stimulate the orthosympathetic
innervation and evaluating the influence over median neurodynamic test in patient with whiplash inmediatly after the technique. This technique can be performed in 2 minutes.
Intervention code [1] 285324 0
Treatment: Other
Comparator / control treatment
No treatment
Control group
Active

Outcomes
Primary outcome [1] 287578 0
Changes in elbow joint amplitude during median neurodynamic test using a goniometer.
Timepoint [1] 287578 0
inmediatly after the technique
Secondary outcome [1] 298440 0
Changes in grip force using a handgrip dynamometer
Timepoint [1] 298440 0
inmediatly after the technique
Secondary outcome [2] 298441 0
changes in cervical pain using a visual analogue scale (VAS).
Timepoint [2] 298441 0
inmediatly after the technique

Eligibility
Key inclusion criteria
Sign the informed consent
whiplash category 1 or 2
Pacients with median neurodinamic test positive
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who whiplash is grade 3 or superior

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients in the "Centro Medico Mar Menor SL" of San Javier meeting the inclusion and exclusion criteria.
A doctor takes care of the subjects meeting the criteria for inclusion and exclusion. The randomization process is conducted by sealed opaque envelopes, containing half of them the number 1 (intervention) or 2 (control), code only known by the interventor.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We are 60 white envelopes with a number inside, 30 envelopes bearing the number 1 and the other 30 to 2, the number 1 belongs to the intervention group and control group number 2.
The method of randomization is to shuffle the envelopes and give it to choose the subject 1, the whole package, the envelope used is discarded.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/09/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 4418 0
Spain
State/province [1] 4418 0
Murcia

Funding & Sponsors
Funding source category [1] 285680 0
Self funded/Unfunded
Name [1] 285680 0
Pedro Jose Antolinos Campillo
Country [1] 285680 0
Spain
Primary sponsor type
Individual
Name
Pedro Jose Antolinos Campillo
Address
Calle Lanzarote, 25
30730, San Javier
Murcia
Country
Spain
Secondary sponsor category [1] 284510 0
None
Name [1] 284510 0
Address [1] 284510 0
Country [1] 284510 0
Other collaborator category [1] 276961 0
Individual
Name [1] 276961 0
Angel Oliva Pascual-Vaca
Address [1] 276961 0
C/ Goleta 6
41740 Lebrija (Sevilla)
Country [1] 276961 0
Spain
Other collaborator category [2] 276962 0
Individual
Name [2] 276962 0
Cleofas Rodriguez Blanco
Address [2] 276962 0
C/ Otono 35
41710 Utrera (Sevilla)
Country [2] 276962 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287668 0
Comite Etico de Experimentacion de la Universidad de Sevilla
Ethics committee address [1] 287668 0
Ethics committee country [1] 287668 0
Spain
Date submitted for ethics approval [1] 287668 0
Approval date [1] 287668 0
05/11/2011
Ethics approval number [1] 287668 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34471 0
Address 34471 0
Country 34471 0
Phone 34471 0
Fax 34471 0
Email 34471 0
Contact person for public queries
Name 17718 0
Pedro Jose Antolinos Campillo
Address 17718 0
Calle Lanzarote, 25
30730 San Javier
Murcia
Country 17718 0
Spain
Phone 17718 0
+34666262728
Fax 17718 0
Email 17718 0
[email protected]
Contact person for scientific queries
Name 8646 0
Pedro Jose Antolinos Campillo
Address 8646 0
Calle Lanzarote, 25
30730 San Javier
Murcia
Country 8646 0
Spain
Phone 8646 0
+34666262728
Fax 8646 0
Email 8646 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.