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Trial registered on ANZCTR


Registration number
ACTRN12611001028998
Ethics application status
Approved
Date submitted
22/09/2011
Date registered
28/09/2011
Date last updated
3/04/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of the suboccipital muscle inhibition technique in craniocervical posture and greater occipital nerve mechanosensitivity
Scientific title
Immediate effects of the suboccipital muscle inhibition technique in craniocervical posture and greater occipital nerve mechanosensitivity in subjects with a history of orthodontia use: a randomized trial
Secondary ID [1] 263096 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Forward head posture 270843 0
Nerve Mechanosensitivity 270849 0
Condition category
Condition code
Physical Medicine / Rehabilitation 271025 271025 0 0
Physiotherapy
Musculoskeletal 271026 271026 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Suboccipital muscle inhibition technique (SMI technique)

With the patient supine, the therapist sits at the head of the table and places the palms of her hands under the subject's head, her fingers contacting the occipital condyles. Then, the therapist locates with the middle and ring fingers of both hands the space between the occipital condyles and the spinal process of the second cervical vertebra. Then, with the metacarpophalangeal joints in 90degrees flexion, she rests the base of the skull on her hands and exerts a constant, but not painful, pressure ventrally, maintaining the index, middle, and ring fingers of both hands extended and together. A very slight traction can be added cranially to decongest the suboccipital zone. During the SMI technique, the subject is asked to keep his eyes closed to avoid eye movements affecting the suboccipital muscle tone.

We set an intervention time of four minutes. The intervention procedure will be performed only once in order to assess the immediate effects of the technique
Intervention code [1] 269442 0
Rehabilitation
Comparator / control treatment
The placebo manouvre consisted in the therapist placing her hands under the patient's skull with the finger tips in contact with the occipital base for four minutes, without any kind of pressure or therapeutic intention. The aim was to provide a manual stimulus as similar as possible to the suboccipital muscle inhibition technique. The subject will be asked to keep his eyes closed as in the intervention techique.

The intervention time for the placebo technique is four minutes and it will be performed only once.
Control group
Placebo

Outcomes
Primary outcome [1] 279683 0
IMPROVEMENT OF CRANIOVERTEBRAL ANGLE IN AT LEAST 10%

The craniovertebral angle (CVA) is measured to be that between a horizontal line that crosses the body of the seventh cervical vertebra (C7) and the line from the tragus of the ear to the spinal apophysis of C7. Two lateral photographs are taken of the subject seated and standing still. For the first photograph, the subjects are asked to sit with their arms on their legs, and to rest their back and buttocks on the back of the chair, with both feet on the ground. The examiner instructs them to fix their gaze on an imaginary point on the wall directly in front. For the second photograph, the subjects stand still in a posture as natural as possible, with arms resting along the body, and directing their gaze as in the previous case.
Timepoint [1] 279683 0
AFTER INTERVENTION
Secondary outcome [1] 294201 0
DECREASE IN GREATER OCCIPITAL NERVE MECHANOSENSITIVITY

Measurements will be made with a Model FPX 25 digital algometer (Wagner Instruments Greenwich, CT), using a 1cm2 area contact head, and applying a pressure gradient of approximately 1kg/cm2/s. For the palpation of the Greater Occipital nerve, we will follow the indications described by Loukas et al. and Mosser et al. locating it laterally with a finger, and approximately one finger's length caudally from the external occipital crest. The reference points on both sides of the head will be labelled with a marker, and three measurements will be made at each one with a resting period of 30 seconds between each measurement. All the subjects are instructed identically: "Let me know when the sensation of pressure becomes uncomfortable or painful".
Timepoint [1] 294201 0
AFTER INTERVENTION

Eligibility
Key inclusion criteria
(i) older than 18 years old
(ii) a history of having used orthodontics
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(i) a history of whiplash injury;
(ii) a history of degenerative disorders of the central and/or peripheral nervous system;
(iii) a history of cranial vault, craniofacial, temporomandibular joint, or any level of spinal fractures and/or surgery;
(iv) suffering or having suffered osteitis, or cranial-vault, craniofacial, or temporomandibular joint rheumatic or tumoural diseases; and
(v) consumption of analgesics or anti-inflammatory drugs within 48 hours prior to data collection

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using coin-tossing
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2010
Actual
1/06/2010
Date of last participant enrolment
Anticipated
Actual
30/09/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment outside Australia
Country [1] 3857 0
Spain
State/province [1] 3857 0
Sevilla

Funding & Sponsors
Funding source category [1] 269920 0
University
Name [1] 269920 0
University of Sevilla (Spain)
Country [1] 269920 0
Spain
Primary sponsor type
University
Name
University of Sevilla
Address
Department of Physiotherapy.
Faculty of Nursing, Physiotherapy and Podiatry.

C/ Avicena s/n 41009 Sevilla (Spain)
Country
Spain
Secondary sponsor category [1] 268926 0
None
Name [1] 268926 0
Address [1] 268926 0
Country [1] 268926 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271905 0
COMITE DE EXPERIMENTACION DE LA UNIVERSIDAD DE SEVILLA
Ethics committee address [1] 271905 0
Ethics committee country [1] 271905 0
Spain
Date submitted for ethics approval [1] 271905 0
15/01/2010
Approval date [1] 271905 0
10/02/2010
Ethics approval number [1] 271905 0
NONE

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

Contacts
Principal investigator
Name 33193 0
Dr Alberto Marcos Heredia-Rizo
Address 33193 0
C/ Avicena s/n 41009, University of Sevilla
Country 33193 0
Spain
Phone 33193 0
(+34 954486507)
Fax 33193 0
Email 33193 0
amheredia@us.es
Contact person for public queries
Name 16440 0
ALBERTO MARCOS HEREDIA RIZO
Address 16440 0
C/ AVICENA S/N

41009 SEVILLA
Country 16440 0
Spain
Phone 16440 0
(+34) 954 48 65 07
Fax 16440 0
(+34) 954 48 65 28
Email 16440 0
amheredia@us.es
Contact person for scientific queries
Name 7368 0
ALBERTO MARCOS HEREDIA RIZO
Address 7368 0
C/ AVICENA S/N

41009 SEVILLA
Country 7368 0
Spain
Phone 7368 0
(+34) 954 48 65 07
Fax 7368 0
(+34) 954 48 65 28
Email 7368 0
amheredia@us.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.