Immediate Effect of Sub Occipital Inhibition Technique on Postural Balance: Stabilometric Study.
Phase: NA
Conditions: Movement Disorders
Sponsor: Cardenal Herrera University

 
 
 
 
 
STUDY PROTOCOL PLAN AND STADISTICAL ANALYSIS PLAN (SAP)  
 
UNIVERSITY CEU CARDENAL HERRERA  
 
Principal investigator: Dr. Sergio Montero Navarro 
 
TITLE: IMMEDIATE EFFECT OF SUBOCCIPITAL INHIBITION TECHNIC ON 
POSTURAL BALANCE: STABILOMETRIC STUDY. 
 
 
Research and Ethics Committee of Cardenal Herrera CEU University 
Number CEI18/201 
NCT ID:  
DATE: 19-06-2019 
 
 
 
 

 
STUDY PROTOCOL PLAN 
 
1. OBJECTIVES 
The objectives of our study are the following: 
General: 
• 
Check whether the technique of suboccipital inhibition influences suboccipital 
rachis proprioceptivity enough to modify postural balance. 
Specific: 
• 
Evaluate immediate changes in the oscillation of the center of gravity when 
standing after the suboccipital inhibition technique. 
• 
Check the variation of the Romberg coefficient after the suboccipital inhibition 
technique. 
 
2. STUDY DESIGN 
A randomized controlled clinical trial of an explanatory, single-blind, blind appraiser 
strategy will be conducted (no relationship between evaluator and auditor). The subject 
will not know his group of belonging and, to strengthen his blinding, will not know how 
many measurements will be made. Participation in the study is free. The evaluation will 
be carried out before and immediately after the intervention. 
All participants will be informed of the purpose of the study through an information 
document prepared for this purpose and will be clarified any doubts that may arise. After 
answering as many questions as necessary, the subject must sign the informed consent 
document to be part of the study. The principles of the Declaration of Helsinki (2004) will 
be respected at all times. The data collected will be treated confidentially by applying the 
current legislation on the protection of personal data (Organic Law 15/1999 of December 
13, Protection of Personal Data) and / or any other applicable. 
This study has been admitted by the Research and Ethics Committee of Cardenal 
Herrera CEU University Number CEI18/201 
 
 
 

 
3. SUBJECTS OF STUDY 
There is an increase in the prevalence of cervicalgia related to postural habits, new work 
practices and the use of electronic devices, traffic accidents and population aging. 
Cervical pain is very frequent with a point prevalence between 10-13%, appearing at 
some point in life up to 70% of the population. Occurs between 11-14% of sick leave. 
This situation justifies the feasibility of obtaining the sample required to carry out the 
study in an adequate time. The sample required for this project according to similar 
articles will be around 30 subjects per group. 
The selection criteria of the sample in this study are as follows. 
3.1. 
Inclusion criteria 
The inclusion criteria will be: a) individuals who suffer neck pain for at least 3 months, b) 
Come to receive physiotherapy treatment at Clinica Osteomed (NRS: 8415-CV), Elche, 
Alicante, c) age between 18 and 65 years old, d) sign the informed consent.   
3.2. 
Exclusion criteria 
Exclusion criteria will be: a) suffering or having suffered pathologies of the postural 
control system (postural sensors, central nervous system or locomotor system), b) 
presenting deformities or orthopedic injuries in the lower limbs or rachis, d) presenting 
pain at the moment of study, e) present contraindications to the intervention under study, 
f) have received physiotherapy treatment in the last six months and g) have undergone 
surgical treatment of any kind. 
Recruitment will be done after the first physiotherapy consultation. The physiotherapist 
will inform the patient of the characteristics of the study and, after checking their eligibility 
to participate in the study, will proceed to sign the informed consent. 
 
4. INTERVENTION PROTOCOL 
The intervention will be carried out by physiotherapists specialized in manual 
manipulative therapy, DO osteopaths, whose training and experience complies with the 
regulation of the provision of health care in osteopathy published in BOE of January 21, 
2016 in the UNE-EN 16686 Standard: 2015 on "Provision of healthcare in osteopathy". 
The suboccipital inhibition technique is performed to release the myofascial restriction of 
the suboccipital region and normalize the proprioceptive afferents of the region. It is done 
with the patient in the supine position and the therapist sitting at the head of the bed with 
the elbows resting on its surface. The therapist palpates the cervical spinous processes 

 
and slides the fingers upwards until contacting the posterior projection of the posterior 
arch of the atlas. Then, flexing the metacarpophalangeal at 90 degrees slowly raises the 
skull. The therapist's hands should remain together and the base of the skull should rest 
on his palms pressing with the index, middle and ring fingers of each hand in a sustained 
manner, but without causing pain. This pressure must be maintained during 4 minutes. 
 
5. STUDY VARIABLES 
5.1. 
Independent variables study object 
The independent variables of the project are: a) belonging to the control or intervention 
group; and b) time, according to the timing of pre-intervention and post-intervention 
measurements. We also recorded as independent variables the general characteristics 
of the sample: age, BMI, sex, hours of weekly sports activity. 
5.2. 
Dependent variables 
The dependent variables of the study are Romberg index and stabilometric data with 
open eyes and closed eyes of the variables as follows:  
• 
Mean of the oscillation on the X axis and on the Y axis. 
• 
Length of the oscillation. 
• 
Surface of the ellipse. 
• 
Speed of the oscillation on the X axis and on the Y axis. 
• 
Average speed of the oscillation. 
 
6. STUDY GROUPS. 
The sample will be divided into 2 groups: Intervention Group and Control Group. The 
suboccipital inhibition technic described will be applied to the intervention group. The 
control group will be given a superficial contact in the same area as the intervention, to 
rule out the exteroceptive effect associated with the therapist's contact. The subjects will 
be assigned to both groups through a computerized system of simple randomization.  
 
 
 

 
7. EVALUATION. 
The evaluation will be done at the Clinica Osteomed physiotherapy center located in 
Elche, where tools, space, evaluators and appropriately prepared interveners are 
available to carry out this project. The evaluation will be carried out in two moments: 
before the intervention and immediately after it. The time between the pre-intervention 
measurement and the intervention is less than 15 minutes. The time elapsed between 
the intervention and the post-intervention measurement will be less than 1 minute. For 
the evaluation a pressure platform  will be used (Diagnostic Support SRL, model "Clinical 
MultiSensor", 4 sensors / cm2, 40 captures / second) and the data will be registered by 
the Milletrix software (Diagnostic Support V.1.0.0.26 ). The stabilometric record will be 
made with aligned heels in a comfortable position for the subject, looking forward at eye 
level on a wall 5 m from the subject. On both sides there will be two clear panels that will 
close a 3 m wide corridor. It will remain silent, constant temperature (20º-23º) and good 
luminosity (2000 Lux). The stabilometric record will have a duration of 52 seconds. The 
measurement will be made without footwear and the orders given to the subject will be 
protocolized so that they do not influence their postural attitude unequally. 
Stabilometric data with open eyes and closed eyes of the variables, mean of the 
oscillation on the X axis and on the Y axis, length of the ball, surface of the ellipse, speed 
of the oscillation on the X axis and on the Y axis, average speed of the oscillation and 
the Romberg index. 
 
8. STUDY SEQUENCE. 
The study will be carried out in two adjoining rooms with enough space to offer freedom 
of movement to both the examiner and the subject of study. In one of them will be the 
evaluator, responsible for making the measurements and collect the pre-intervention and 
post-intervention values, using a stabilometric platform, a scale with stadiometer and a 
computer. The time that elapses between the execution of the technique and the start of 
the post-intervention measurement is, in all cases, less than one minute. In the other 
room, the intervener will be in charge of performing the randomization after the first 
measurement and performing the corresponding intervention. It will have a treatment 
table for the patient and a stool for the intervener. Between both rooms there are 
approximately eight meters without steps or unevenness. 
 
A. Recruitment: Recruitment will be done after the first physiotherapy consultation. The 

 
physiotherapist will inform the patient of the characteristics of the study and, after 
checking their eligibility to participate in the study, will proceed to sign the informed 
consent. 
B. Evaluation pre-intervention. The subject of the study begins his participation in the 
evaluation room. The evaluator performs the pre-intervention evaluation. Following the 
protocol of the "Association Française de Posturologie" (AFP) the subject will be in a 
well-lit room (2000 Lux approximately), located on the platform with the heels separated 
4 cm and with the tips of the feet forming a 30º angle. You will look forward to a fixed 
point located 5 meters above your eyes. On both sides, two light colored panels are 
placed. The width of the tunnel thus formed is 3 meters. In addition the room will be silent 
and the temperature will be constant between 20º and 23ºC so that the physiology of the 
subject is not altered to the point of feeling cold or sweating. We have decided to use 
this protocol because they are healthy subjects because, despite being an artificial 
position, we unify all the subjects in a position of certain instability because their heels 
are very close and their feet are symmetrical. Each foot is separated 15º of the sagittal 
plane. We will make the assessment with open eyes and closed eyes to determine the 
Romberg coefficient. 
C. Randomization and intervention. The subjects are subjected at that moment to the 
randomization process. From that moment on, the sequence differs according to the 
group to which the individual has been assigned (control or intervention). 
D. Evaluation post-intervention. A second stabilometric measurement is carried out 
immediately after the application of the technique, concluding the individual study. 
 
9. PROVIDED BENEFITS 
The technique proposed in this study should have an impact on the symptoms of 
instability and balance disorders associated with cervicalgia. The technique under study 
may be included in the protocols of conservative physiotherapy treatment for patients 
with cervicalgia and cervicogenic instability. 
 
 
 
 

 
 
Statistical Analysis Plan (SAP) 
 
Size Sample and Feasibility 
The statistical program that we will use will be SPSS v.20. To determine the sample size, 
a pilot study will be conducted with the same methodology as the original study to a 
group of 10 subjects. These subjects will be assigned to the same group. This pilot study 
will provide us with the estimates of the mean and variance of the response variable, 
thus being able to calculate the appropriate sample size by determining a minimum 
power value of 80% (W> 80%) and a confidence level of 95% (p <0.05). 
The pilot sample will be part of the final sample to be studied if there are no changes in 
the protocol or in the variables to be measured. 
 
For the descriptive analysis, the mean and the standard deviation will be calculated. To 
prove normality, the Kolmogorov-Smirnov test, or Shapiro-Wilk test, and for 
homoscedasticity the Levene test. To evaluate the pre-post intra-group differences, the t 
test will be used for related samples (if they are parametric) or the Mann-Whitney U test 
(if they are nonparametric). For the analysis of pre-post intergroup differences the 
ANOVA statistic will be used. The significance value is set at p <0.05.