Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001033932
Ethics application status
Approved
Date submitted
27/09/2011
Date registered
29/09/2011
Date last updated
6/07/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects after the application of the first rib thrust technique in patients with whiplash syndrome.
Scientific title
The first rib thrust technique applied to patients suffering from whiplash disorder causing changes in muscle hardness and pressure pain theresholds.
Secondary ID [1] 273119 0
"Nil known"
Universal Trial Number (UTN)
U1111-1124-7118
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Whiplash disorder 270867 0
Muscle hardness 270868 0
Pressure pain thresholds 299416 0
Condition category
Condition code
Physical Medicine / Rehabilitation 279044 279044 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Before the intervention, the practitioner will take preintervention measurement of the hardness of some muscles with a Myotonometer and the pressure pain thresholds with an algometer.
After the measurements,(40 minutes) the practitioner will apply a thrust technique to the first rib with the patient in seated position and the practitioner behind him. The technique has a duration of 90 seconds.The measurements will be taken again after the thrust technique, so the thrust technique will be applied only once to the patient.
Intervention code [1] 269456 0
Treatment: Other
Intervention code [2] 269457 0
Rehabilitation
Comparator / control treatment
The same intervention will be made to the control group, but they will receive a sham- manual technique: the therapist will simule the manipulative procedure but without taking up the tissue tension or performing any thrust action. This position will be mantained for 15 seconds.
Control group
Placebo

Outcomes
Primary outcome [1] 279698 0
Changes in the hardness of the following muscles: masseter, stercleidomastoideus, scalenus, trapezius, biceps and triceps in relaxed and contracted position.
To perform these steps it will be used a Myotonometer (R). These will be the preintervention measurements. After the intervention the measurements will be repeated (postintervention measurements).
Timepoint [1] 279698 0
Preintervention measurements will be taken immediately prior to the intervention. Post intervention measurements will be taken immmediately post the intervention.
Secondary outcome [1] 294243 0
Changes in pressure pain theresholds on the following points: a point through the path of the trigeminus nerve, a point through the path of the median nerve, a point through the path of the cubital nerve, a point at the trapezius muscle, at the biceps muscle and at the triceps muscle. These will be preintervention measurements
These measurements will be taken with a surface algometer. After the intervention the measurements will be repeated (postintervention measurements).
Timepoint [1] 294243 0
Preintervention measurements will be taken immediately prior to the intervention. Post intervention measurements will be taken immmediately post the intervention.

Eligibility
Key inclusion criteria
1. Patients who are diagnosed of Whiplash grade I or II according to the Quebec Task Force.
2. .Patients who show a positive response to the cervical rotation lateral flexion test.
3. Patients who give written informed consent.
4. Man or woman over 18 and under 65 years old.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
`-Patients suffering from cervicalgia, if this one is not related to the whiplash syndrome.
-Patients who pretend to have suffered a whiplash.
-Patients who are not diagnosed as have had suffered a whiplash.
- Level III or more by the Quebec Task Force classification.
-Malformations or previous injuries.
-Contraindication to the first rib manipulation technique, such as fracture at any level of the cervical spine.
-Tumor, osteitis, risk of cerebral hemorrhage.
-Any kind of rheumatism.

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)
Every subject will choose a red ball or a green ball. If he chooses he green one , he will be recruited to the control group. The subject who chooses the red ball will be recruited to the tratment group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomization.com website
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
Completed
Date of first participant enrolment
Anticipated
12/09/2011
Actual
12/09/2011
Date of last participant enrolment
Anticipated
18/01/2012
Actual
18/01/2012
Date of last data collection
Anticipated
26/01/2012
Actual
26/01/2012
Sample size
Target
10
Accrual to date
Final
10
Recruitment outside Australia
Country [1] 3867 0
Spain
State/province [1] 3867 0
Seville

Funding & Sponsors
Funding source category [1] 269939 0
University
Name [1] 269939 0
University of Seville
Country [1] 269939 0
Spain
Primary sponsor type
University
Name
Marta Pena Salinas
Address
Physiotherapy Department. University of Seville. Avicena St., 41009
Seville (Spain)
Country
Spain
Secondary sponsor category [1] 268937 0
University
Name [1] 268937 0
University of Seville
Address [1] 268937 0
Avicena St. 41009- Seville (Spain)
Country [1] 268937 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271907 0
Ethics Committee, University of Seville.
Ethics committee address [1] 271907 0
Ethics committee country [1] 271907 0
Spain
Date submitted for ethics approval [1] 271907 0
07/07/2011
Approval date [1] 271907 0
16/07/2011
Ethics approval number [1] 271907 0

Summary
Brief summary
Muscles show several changes after a traumatic event, such a whiplash. We will focus our study into changes in the hardness of a number of muscles in patients suffering from a whiplash. We will use a device called Myotonometer for this purpose. We will also measure changes in pressure pain threshold in these patients with an algometer.
The measures will be taken before and after the intervention. The intervention will consist of a first rib manipulation technique.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33204 0
Dr Marta Pena Salinas
Address 33204 0
Physiotherapy Department.
Avicena St, , 41009, Seville (Spain)
Country 33204 0
Spain
Phone 33204 0
+0034636287228
Fax 33204 0
Email 33204 0
[email protected]
Contact person for public queries
Name 16451 0
Dr Marta Pena Salinas
Address 16451 0
Physiotherapy Department. University of Seville, Avicena St, Seville-41009 (Spain)
Country 16451 0
Spain
Phone 16451 0
+0034 636 287228
Fax 16451 0
Email 16451 0
[email protected]
Contact person for scientific queries
Name 7379 0
Dr Marta Pena Salinas
Address 7379 0
Berlin St 20, Seville, 41012-Spain
Country 7379 0
Spain
Phone 7379 0
+0034 636 287228
Fax 7379 0
Email 7379 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
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