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Trial registered on ANZCTR


Registration number
ACTRN12614000607673
Ethics application status
Not yet submitted
Date submitted
28/05/2014
Date registered
6/06/2014
Date last updated
6/06/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Changes in pain perception, cervical range of movement and pressure pain thresholds following dorsal manipulation in patients with acute grade II whiplash: a randomized controlled trial
Scientific title
Short term changes in self-reported pain measured by VAS, cervical active range of motion in all planes and pressure pain threshold at standard locally and remotely points after a posteroanterior, end-range dorsal manipulation at the more painful spinous process level (up to T7) localized by manual palpation compared with placebo in acute grade II whiplash patients (up to 3 weeks after the accident) classified following the criteria of the clinical classification of whiplash associated disorders (WAD) defined by the Quebec Task Force in 1995
Secondary ID [1] 284677 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Whiplash associated disorders (WAD) 292017 0
Condition category
Condition code
Injuries and Accidents 292362 292362 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 292363 292363 0 0
Other physical medicine / rehabilitation
Musculoskeletal 292427 292427 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Group: Direct thrust technique applied at more painful/tenderness dorsal vertebral level (up to D7) localized by manual palpation.
The approximate duration of the intervention is 3 minutes.
The intervention is performed twice maximum (the manipulation will be repeated if the initial manipulation not result in a popping sound, and will be performed inmediately after the first, if required) and administered by a manual therapist specialist.
No active shock waves are administered to the intervention group
Intervention code [1] 289462 0
Rehabilitation
Intervention code [2] 289516 0
Treatment: Other
Comparator / control treatment
Placebo: application of sham shock waves with a focused shock wave therapy device without placing conductive gel and without pressure for 3 minutes.
The placebo treatment is administered to participants on a single occasion only.
Control group
Placebo

Outcomes
Primary outcome [1] 292218 0
self-reported cervical pain
Timepoint [1] 292218 0
at baseline and at short term (immediately after the intervention) measured by a 100mm visual analogue scale
Secondary outcome [1] 308442 0
cervical active range of motion
Timepoint [1] 308442 0
at baseline and at short term (immediately after the intervention) measured by digital goniometer
Secondary outcome [2] 308443 0
pressure pain threshold at C5-C6 zygapophyseal/ temporomandibular joints, tibialis anterior/ masseter/ temporalis muscles, second metacarpal and supraorbital region.
Timepoint [2] 308443 0
at baseline and at short term (immediately after the intervention) measured by digital algometer
Secondary outcome [3] 308444 0
elbow extension range of movement by ULNT-1 test
Timepoint [3] 308444 0
at baseline and at short term (immediately after the intervention) measured by standard goniometer.

Eligibility
Key inclusion criteria
(a) medical diagnosis of Whiplash G II (according to the Quebec Task Force); (b) age (18-55 years); (c) acute stage (<3 weeks after the motor vehicle accident)
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) have experienced a concussion during the accident ; (b) loss of consciousness due to accident; (c) loss of postural balance at the time of conducting the study; (d) cervical pain in the 3 months prior to the accident ; (e) have suffered soft tissue therapy in the 3 months prior to the study (i.e. treatment for neck pain ); (f) received shock wave therapy for any cause prior to this study; (g) history of previous whiplash; (h) history of psychological conditions (i.e.depression disorder, post -traumatic stress , ...); (i) history of neurological and / or rheumatologic and / or circulatory disorders (hypertension , heart disease or meningitis) ; (j) be affected by other physical disease that may affect the study results (i.e. fibromyalgia , ...); (k) malformations , injury or previous surgery in the cervical spine; (l) any contraindications to the spinal manipulation (i.e. tumor disease , osteitis, congenital diseases ... ); (m) be pregnant; (n) not sign the inform consent for participation in the study; (o) take any analgesic or anti-inflammatory drug and / or muscle relaxant for 48 hours prior to the study

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)
An external consultant prevented access to the sequence for those participating in the study (holder of the allocation schedule)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomised number table designed by an Internet website (randomized.com)
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
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
7/07/2014
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] 6075 0
Spain
State/province [1] 6075 0
Balearic Islands

Funding & Sponsors
Funding source category [1] 289301 0
Self funded/Unfunded
Name [1] 289301 0
Country [1] 289301 0
Primary sponsor type
University
Name
Universidad de las Islas Baleares
Address
Ctra. Valldemossa, km 7.5 C.P. 07122-Palma de Mallorca, Espana
Country
Spain
Secondary sponsor category [1] 287971 0
Other
Name [1] 287971 0
Policlinica Miramar
Address [1] 287971 0
Cami de la Vileta, 30, C.P. 07011 Palma de Mallorca, Espana
Country [1] 287971 0
Spain

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 291065 0
Comite Etico de Investigacion Clinica Illes Balears
Ethics committee address [1] 291065 0
Ethics committee country [1] 291065 0
Spain
Date submitted for ethics approval [1] 291065 0
13/06/2014
Approval date [1] 291065 0
Ethics approval number [1] 291065 0

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

Contacts
Principal investigator
Name 48742 0
Prof Juan Carlos Fernandez Dominguez
Address 48742 0
Universitat de les Illes Balears (UIB)
Ctra. Valldemossa km 7.5
Edificio Beatriu de Pinos, despacho 44
07122 Palma de Mallorca, Islas Baleares
Country 48742 0
Spain
Phone 48742 0
+ 34 971259513
Fax 48742 0
+ 34 971172309
Email 48742 0
jcarlos.fernandez@uib.es
Contact person for public queries
Name 48743 0
Juan Carlos Fernandez Dominguez
Address 48743 0
Universitat de les Illes Balears (UIB)
Ctra. Valldemossa km 7.5
Edificio Beatriu de Pinos, despacho 44
07122 Palma de Mallorca, Islas Baleares
Country 48743 0
Spain
Phone 48743 0
+ 34 971259513
Fax 48743 0
+ 34 971172309
Email 48743 0
jcarlos.fernandez@uib.es
Contact person for scientific queries
Name 48744 0
Juan Carlos Fernandez Dominguez
Address 48744 0
Universitat de les Illes Balears (UIB)
Ctra. Valldemossa km 7.5
Edificio Beatriu de Pinos, despacho 44
07122 Palma de Mallorca, Islas Baleares
Country 48744 0
Spain
Phone 48744 0
+ 34 971259513
Fax 48744 0
+ 34 971172309
Email 48744 0
jcarlos.fernandez@uib.es

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.