Effects on Plantar Support After Deep Dry Needling in Posterior Tibial Muscle: Baropodometric 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: Effects on Plantar Support After Deep Dry Needling in Posterior Tibial 
Muscle: Baropodometric study 
Research and Ethics Committee of CEU Cardenal Herrera University Number: CEI13/02 
NCT ID: [not yet assigned] 
DATE: 3-18-2013 

STUDY PROTOCOL PLAN 
Objectives: 
The objectives of our study have been the following: 
General: 
-
Evidence changes in pressure in the plantar support in dynamics after treatment
with deep dry needling in the tibialis posterior myofascial trigger point. 
Specific: 
-
Analyze the variation of the plantar dynamics in the subjects without intervention
to avoid learning bias of the methodology of the baropodometric registry. 
-
Evidence if deep dry needling is effective in the treatment of myofascial trigger
point. 
-
Observe if there are differences in the treatment taking into account the
covariates measured such as age, sex, and physical activity practice and body 
mass index. 
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. 

In the evaluation room, the evaluator, after taking the measurements of weight and 
height. 
To locate the myfascial trigger point in the tibialis psoterior, the palpation technique will 
be used, grasping the belly of the muscle between the thumb and the 2nd and 3rd fingers. 
The evaluator will press the fibers with a forward and backward movement to find the 
taut bands. Once the taut band is found longitudinally, the nodule and the point of 
greatest sensitivity to pressure will be located. 
Once the myofascial trigger point is located, it will be marked with a dermal marker. 
Those subjects in whom the myofascial trigger point can not be located with precision, 
will be excluded from the study. 
After having marked the myofascial trigger point, the evaluator will make the subject the 
algometry in the myofascial trigger point. 3 measurements will be taken with an interval 
of 20 seconds between measurement and measurement, and the average of the three 
measurements obtained will be calculated. 
Next, The baropodometry will be carried out. The subject will perform the march on the 
platform for one minute. At the moment that the baropodometer registers correctly the 
data will warn us. 
Once the pre-intervention measurements have been made, the subject will go to the 
adjoining room to carry out the intervention. 
The intervention sequence varied depending on the group to which the subject "Group 
intervention 1" (G1), 

- "Intervention group 1" (G1): the deep dry needling technique will be performed with a
duration of less than one minute in the tibialis posterior. 
Initial position: The patient will be placed supine with an external rotation of the 
hip and slight knee flexion. The auditor is placed on the homolateral side. 
Placement of hands: the auditor locates the myofascial trigger point in the tibialis 
posterior with the left hand on the inside, back of the tibia, and perform the 
technique with the right hand. 
Technique: The inspector, with gloves, disinfects the area to be treated with 70º 
alcohol. Once the alcohol is applied, the intervenor locates and takes the 
myofascial trigger point and places the needle with the guide tube resting on the 
skin of the patient. The inspector holds the guide tube between the index and 
middle fingers lightly touch the needle with the index finger of the other hand to 
insert the needle perpendicularly into the skin, directing it towards the inspector's 
thumb. Once the needle is inserted subcutaneously, the guide tube is removed. 
The controller deepens the needle to myofascial trigger point, and makes fast 
inputs and outputs into it. The rapid exit is made to the subcutaneous cellular 
tissue, outside the muscle, but not outside the skin. Next, hemostasis is 
performed in the area. Once this hemostasis is completed, the patient is 
incorporated and dressed. 
- "Control group (G2)": the simulated dry puncture technique will be performed.

Initial position: The patient will be placed prone. The interventor is placed on the 
homolateral side. 
Technique: The patient lies on the stretcher without the trousers. The interventor, 
with the guide tube, simulates the technique of puncture in the right twin of the 
subject. The comptroller cleans the area with 70º alcohol. Once the alcohol is 
applied, he performs the simulated dry needling technique in a plane with his 
index and middle fingers with the guide tube. It is important that the subject has 
his head stuck in the hollow of the head of the stretcher throughout the technique 
to make a correct masking. 
Next, a simulation of hemostasis is performed in the area. Once this simulation 
is finished, the patient is incorporated and dressed. 
Once the intervention is done, the subject will return to the evaluation room to proceed 
to the evaluation immediately after the intervention (POSTINT), both algometric and 
baropodometric measurements. After these measurements, the subject will be 
summoned at the same time to return at 24 hours (POST24h) and at 72 hours 
(POST72h) to perform the corresponding algometric and goniometric measurements. 
This study will be carried out in two adjoining rooms, with a sufficient amplitude to offer 
freedom of movement, both to the evaluator and the auditor and the subject of the study. 
In one of the rooms will be the evaluator to perform the measurements and collect the 
pre- and post-intervention values. In the adjoining room will be the controller, in charge 
of carrying out the corresponding intervention. 

Between both rooms there are about eight meters of distance without steps or 
unevenness, and they will maintain an identical and constant temperature. 

Statistical Analysis Plan (SAP) 
For the qualitative variables we will make some frequency tables. On the 
other hand, for the quantitative variables, maximums, minimums, mean values 
and the standard deviation will be calculated. 
To check the homogeneity of the intervention and control groups, the 
association with the explanatory variables sex, age, body mass index and sport 
hours will be measured using the Chi-square test or the T-student test as 
appropriate. 
The equality of mean values of each dependent variable will be tested, 
both in the intervention group and in the control group, as in the four 
measurement times by means of an ANCOVA procedure (analysis of the 
covariance with repeated measures). 
The confidence interval will be 95% 

GENERAL STUDY INFORMATION AND INFORMED CONSENT 
UNIVERSITY CEU CARDENAL HERRERA  
Principal investigator: Dr. Sergio Montero Navarro 
TITLE: Effects on Plantar Support After Deep Dry Needling in Posterior Tibial 
Muscle: Baropodometric study 
Research and Ethics Committee of CEU Cardenal Herrera University Number: CEI13/02 
NCT ID: [not yet assigned] 
DATE: 3-18-2013 

GENERAL STUDY INFORMATION 
TITLE: Effects on Plantar Support After Deep Dry Needling in Posterior Tibial 
Muscle: Baropodometric study 
Mr. Sergio Montero Navarro, Physiotherapist, principal investigator and researcher reports 
that: 
The study in which will be part of joint mobility and pain at the foot. In this way we can 
contribute to promote the health status of people. A response inmediately after intervention, 
at 24 hours and 72 hours after the intervention. 
The tests performed are simple and in no case involve difficulty, fatigue, danger, injury, 
pain or adverse reaction. They will be held in the practice room of the CEU Cardenal 
Herrera University in Elche, specially prepared for the occasion and in the best conditions 
of safety and hygiene and always using approved material.  
They will be carried out by collegiate physiotherapists in the School of Physiotherapists of 
the Valencian Community. 
The general data of the subject will be collected (name, age, sex, physical variables and 
clinical history). The article must be sent with comfortable clothes The day that sea cited by 
the researcher, previous notice. Personal data is recognized in this study.  
The personal data are confidential, apply to the protection of personal data (Organic Law 
15/1999, December 13) and any other thing that may be applicable. 
This study was approved by the Research and Ethics Committee of 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 201 
Firm