Stabilometric and Baropodometric Evaluation of Osteopathic Scaphoid Tug Manipulation
Phase: NA
Conditions: Manipulation, Osteopathic
Sponsor: Cardenal Herrera University

 
 
 
 
 
 
 
 
 
 
 
 
 
 
STUDY PROTOCOL PLAN AND STADISTICAL ANALYSIS PLAN (SAP) 
 
UNIVERSITY CEU CARDENAL HERRERA 
 
Principal investigator: Dr. Sergio Montero Navarro 
 
TITLE: Stabilometric and baropodometric evaluation of osteopathic scaphoid tug 
manipulation 
Research and Ethics Committee of CEU Cardenal Herrera University Number: CEEI22/322 
 
NCT ID: [not yet assigned] 
 
DATE: 10/13/2022 

 
STUDY PROTOCOL PLAN 
 
 
Objectives: 
 
The objectives of our study have been the following: 
 
 
General: 
 
The main objective of this study was to evaluate, in healthy individuals, the stabilometric 
and baropodometric modifications recorded after an osteopathic tug manipulation of 
the scaphoid, neurophysiologically related to the static and postural control system of 
the body (exocaptor input) and biomechanically as a structure that communicates the 
body with the ground 
 
 
Specific: 
 
To evaluate by means of stabilometry the modifications in the variables of oscillation in 
X axis, oscillation in Y axis and ellipse area between the intervention group and the 
control group after the performance of an osteopathic scaphoid tug manipulation or a 
placebo technique respectively and to evaluate the results. 
To assess the changes in the variables % weight load, bearing surface and maximum 
pressure in both feet by baropodometry between the intervention group and the control 
group after the application of a scaphoid tug manipulation or a placebo manoeuvre 
respectively and to compare the results. 
To study and compare the results of the stabilometric and baropodometric variables 
obtained between the subgroups of the intervention group after the osteopathic tug 
manipulation of the scaphoid: audible and non-audible manipulation and to compare the 
results. 

 
Volunteers who want to participate in the study will read the general information of the 
study and sign the informed consent to participate in the study. 
Once the informed consent has been read and delivered, the evaluator will check that 
they meet the inclusion criteria. After the data collection, a randomization (Epidat V4.0) 
of the selected subjects will be carried out to assign them to one of the intervention 
groups. 
 
 
The sequence of the study was as follows: 
 
1. Information about the study to the subjects likely to participate. 
 
2. 
Provision of the informed consent form to be read and signed by the patient 
(appendix I). 
3. 
The evaluator will take the data for the clinical history. 
 
4. 
The assessor will evaluate the mobility of the scaphoid of the right foot and will 
verify that it is in osteopathic external rotation dysfunction, if this dysfunction is not 
present, the subject will be excluded from the study. 
5. 
The assessor shall collect data to obtain the independent variables of 
stabilometry and baropodometry by means of standardised recording on the 
measurement platform in a standardised room for this purpose. 
6. 
The patient will go to an adjoining room with the auditor to carry out the 
randomisation process (random number generator) and thus classify the patient into the 
experimental or control group. 
7. 
Implementation of the intervention: in the experimental group, the scaphoid 
tug technique will be performed. In the control group patients a sham technique will be 
applied. 
8. 
The patient will return to the assessment room with the assessor for data 
collection to obtain the variables of stabilometry and baropodometry by standardised 
recording on the measurement platform, as was done previously. 

 
9. 
Collection of data on computer support by means of a database. 
 
 
Baropodometric and stabilometric assessment: 
 
Stabilometric and baropodometric assessment was carried out using this sequence: 
 
- The subject should be dressed in comfortable clothing and barefoot on the measuring 
platform. 
- Upright position with arms relaxed. 
 
- Placement of a wooden pattern for the positioning of the patient's feet, instructing him 
to place his feet against the edges of the wooden pattern and the heels subsequently 
contacting the guide (heel separation 2 cm and separation of 30º). Once positioned, the 
wooden pattern is removed. 
- Stabilometric measurements and recordings: this shall be taken before the 
baropodometric recording, with a recording time of 51 seconds 2 tenths (standardised 
and consensual recording time). 
- Measurement and baropodometric recording: this recording shall be performed after 
the stabilometric recording while maintaining the same posture. 
The stabilometric evaluation will be carried out with the eyes open, as only the foot 
sensor will be evaluated in the study. 
The stabilometric scan of this study will provide the following data: 
 
- Oscillation about the X-axis. 
 
- Y-axis oscillation. 
 
- Area of the ellipse. 
 
The static baropodometric scan of this study shall provide the following data: 
 
- Area of support of the foot. 
 
- Percentage of body load supported by each foot. 
 
- Point of maximum plantar pressure. 

 
Scaphoid mobility assessment. 
 
 
Scaphoid mobility will be assessed by means of a manual mobility test, for which the 
eversion restriction of the first ray of the foot will be evaluated: patient lying supine on 
the stretcher, the assessor standing at the patient's feet, then takes the internal arch with 
one hand in a duckbill and with the other hand fixes the rearfoot at 90º, once the sockets 
are fixed he checks the direction of the restriction by performing a compression to test 
the talus-scaphoid and a lighter axial compression to test the first wedge-scaphoid joint. 
If there is restriction of scaphoid inversion or internal rotation movement, the test is 
positive, indicating that the scaphoid is in an osteopathic external rotation lesion. 
 
 
Osteopathic tug manipulation of the scaphoid. 
 
 
The aim of the scaphoid tug technique is to act on the scaphoid inferiority and external 
rotation lesion, releasing the scaphoid joint restriction in external rotation, correcting the 
possible flattening of the plantar vault and thus relaxing the possible hypertonia of the 
posterior tibialis. 
The sequence of execution of the scaphoid tug technique shall be as follows: patient in 
the supine position, the intervener in a double feint at the patient's feet facing the 
patient's head, slightly oblique to the outside. The inner hand of the intervener makes 
contact with the pisiform through the hypothenar eminence and ulnar border of the hand 
over the scaphoid tubercle, the outer hand reinforces the contact. The thumbs are 
directed to the sole of the patient's foot. The parameters are sought by bringing the sole 
of the foot into eversion, thus bringing the scaphoid into internal rotation, i.e. in the 
direction of correction. To reduce the slack, the operator drops his body weight 
backwards while increasing the internal rotation parameter of the scaphoid. The 

 
manipulation is performed by associating a rapid traction movement with an increase of 
the correction parameter towards scaphoid internal rotation. 

 
Statistical Analysis Plan (SAP) 
 
 
A descriptive and exploratory analysis of the variables of interest will be carried out in 
order to detect anomalous cases and to clean the database. The assumption of normality 
will be tested with the Shapiro-Wilks test in combination with an analysis of Q-Q and Q- 
Q normality plots without trend. The assumption of equality of variances will be tested 
with Levene's test. A repeated measures ANOVA model will be applied with the variable 
of interest as the within-subjects factor (three levels) and the group as the between- 
subjects factor (two levels). Bonferroni correction will be used for two-to-two 
comparisons. Effect size will be estimated with Cohen's d (1988) where values around 
0.20 will be considered small effect size; around 0.50 moderate and 0.80 or higher, large. 
 
The statistical analysis software used will be IBM SPSS Statistics 24.0 (SPSS Inc. IBM 
Company, 2010) and a 95% confidence interval will be applied in all statistical tests. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
GENERAL STUDY INFORMATION AND INFORMED CONSENT 
UNIVERSITY CEU CARDENAL HERRERA 
Principal investigator: Dr. Sergio Montero Navarro 
 
TITLE: Stabilometric and baropodometric evaluation of osteopathic scaphoid tug 
manipulation 
 
Research and Ethics Committee of CEU Cardenal Herrera University Number: CEEI22/322 
 
NCT ID: [not yet assigned] 
 
DATE: 10/13/2022 

 
 
GENERAL STUDY INFORMATION 
 
TITLE: Stabilometric and baropodometric evaluation of osteopathic scaphoid tug 
manipulation 
 
Mr. Sergio Montero Navarro, Physiotherapist, principal investigator and researcher reports 
that: 
The study focuses on the boropodometric and stabilometric modifications that occur 
immediately after an osteopathic scaphoid tug manipulation. In this way we can contribute 
to promoting people's state of health. 
 
The tests performed are simple and in no case involve difficulty, fatigue, danger, injury, pain 
or adverse reaction. They will be carried out in the room of a registered clinic specially 
prepared for the occasion and in the best conditions of safety and hygiene and always with 
approved material. 
 
They will be carried out by physiotherapists who are members of the Association of 
Physiotherapists of the Valencian Community. 
 
The general data of the subject will be collected (name, age, sex, physical variables and 
clinical history). The subject should be sent in comfortable clothing. On the day that the 
researcher summons the subject, with prior notice. Personal data are acknowledged in this 
study. 
 
Personal data are confidential, apply to the protection of personal data (Ley Orgánica 
15/1999, de 13 de diciembre) and anything else that may be applicable. 
 
This study was approved by the Research and Ethics Committee of the CEU Cardenal Herrera 
University. 

 
INFORMED CONSENT 
Mr/Mrs .................................................... .............................................. with Number 
identification ........................................... freely and voluntarily, I DECLARE: 
 
That I have read the information contained in this document about the general information 
of the study. 
 
I have been informed that all tests are simple to perform and do not produce harmful effects 
on health. They will be carried out in appropriate facilities and will be carried out by 
qualified and specialized personnel. 
 
I have also been informed that, the data collected in this study will be treated confidentially, 
applying the current legislation on protection of personal data (Organic Law 15/1999, of 
December 13) and any other applicable. 
 
Therefore, I give my consent and I authorize Mr. Sergio Montero Navarro, to carry out the 
detailed study in this document with the help of the necessary personnel with the 
appropriate qualification and specialization. 
 
In Elche, to ...... of .......................................... of 202.. 
 
 
Firm