Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001238965
Ethics application status
Approved
Date submitted
29/11/2011
Date registered
5/12/2011
Date last updated
5/12/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
suboccipital inhibition technique effectiveness over median neurodynamic test in whiplash patients
Scientific title
suboccipital musculature inhibition technique effectiveness over the elbow extension during median nerve neurodynamic test in whiplash patients
Secondary ID [1] 273493 0
Nil
Universal Trial Number (UTN)
U1111-1126-1510
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
whiplash injuries 279282 0
Condition category
Condition code
Musculoskeletal 279480 279480 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
we make a suboccipital musculature inhibition technique trying to relax the myodural brigde, and so measure the impact of this technique on the dural tissue and show it using the median neurodynamic test by measuring the range of elbow.
The suboccipital musculature inhibition technique is performed for a total of 3 minutes, estimated time as sufficient so that there is a relaxation of the muscles.
This technique only is perform once in each patient
Intervention code [1] 283810 0
Rehabilitation
Comparator / control treatment
Placebo.
Hip and knee flexion-extension movement from the measure opposite side.
Given that this movement has no influence on the dural structure, must not cause any change in the median nerve neurodynamic test of the subject, so the patient feels that carried out you intervention, thus trying to blind patient.
Control group
Placebo

Outcomes
Primary outcome [1] 286047 0
Change in the elbow extension range during the median neurodynamic test
Timepoint [1] 286047 0
1 minute after the technique
Secondary outcome [1] 295034 0
Change in the patients pain, using the scale visual analog.
Timepoint [1] 295034 0
1 minute after the technique
Secondary outcome [2] 295035 0
Changes in the patients hand strengh. To perform this measurement use a dynamometer of hand grip
Timepoint [2] 295035 0
1 minute after the technique

Eligibility
Key inclusion criteria
Patient who suffered whiplash injuries grade I or II
median neurodynamic test positve
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
suboccipital technique contraindications
Patient with cervical pain in the last 3 month
Patient with whiplash grade III or IV

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)
envelopes with a number in its interior, assigning the 1 for intervention the 2 for the control
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The envelopes are interleaved and the patient chooses one.
Given that I only need 40 patients (20 for the intervention group and 20 for the control group), is it is a way forward which I think is fair and out given that each patient has an equal chance to go to one group or another and at the same time maintaining the balance in the number of patients allocated to each group.
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
12/12/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 3984 0
Spain
State/province [1] 3984 0

Funding & Sponsors
Funding source category [1] 284283 0
Self funded/Unfunded
Name [1] 284283 0
Pedro Jose Antolinos Campillo
Country [1] 284283 0
Spain
Primary sponsor type
Individual
Name
Pedro Jose Antolinos Campillo
Address
Calle Lanzarote, 25, San Javier (Murcia) 30730
Country
Spain
Secondary sponsor category [1] 283235 0
None
Name [1] 283235 0
Address [1] 283235 0
Country [1] 283235 0
Other collaborator category [1] 260363 0
Individual
Name [1] 260363 0
Antonio Francisco Martinez Franco
Address [1] 260363 0
C/ Ronda Norte, 21, 3 C
30009, Murcia.
Country [1] 260363 0
Spain
Other collaborator category [2] 260364 0
Individual
Name [2] 260364 0
Angel Oliva Pascual-Vaca
Address [2] 260364 0
C/ Goleta 6
41740 Lebrija (Sevilla)
Country [2] 260364 0
Spain
Other collaborator category [3] 260365 0
Individual
Name [3] 260365 0
Cleofas Rodriguez Blanco
Address [3] 260365 0
C/ Otono 35
41710 Utrera (Sevilla)
Country [3] 260365 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286242 0
Comite etico de Experimentacion de la Universidad de Sevilla
Ethics committee address [1] 286242 0
Ethics committee country [1] 286242 0
Spain
Date submitted for ethics approval [1] 286242 0
Approval date [1] 286242 0
05/11/2011
Ethics approval number [1] 286242 0

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

Contacts
Principal investigator
Name 33459 0
Address 33459 0
Country 33459 0
Phone 33459 0
Fax 33459 0
Email 33459 0
Contact person for public queries
Name 16706 0
Pedro Jose Antolinos Campillo
Address 16706 0
C/ Lanzarote, 25, San Javier (Murcia) CP 30730
Country 16706 0
Spain
Phone 16706 0
666262728
Fax 16706 0
Email 16706 0
[email protected]
Contact person for scientific queries
Name 7634 0
Pedro Jose Antolinos Campillo
Address 7634 0
C/ Lanzarote, 25, San Javier (Murcia) CP 30730
Country 7634 0
Spain
Phone 7634 0
666262728
Fax 7634 0
Email 7634 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.