Effects of a Manual Therapy Program to Reduce the Evolution Time of Axillary Web Syndrome
Phase: NA
Conditions: Breast Cancer, Mastectomy; Lymphedema, Thrombi, Thrombosis, Shoulder Syndrome, Movement Disorders
Sponsor: University of Malaga

Effects of a manual therapy program to reduce the evolution time of
axillary web syndrome in women affected by breast cancer.
Algeciras, Cádiz , Spain. 29 October 2021
NCT ID not yet assigned. 
Unique Protocol ID: AWS 
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TABLE OF CONTENTS
General information
ABSTRACT
QUALIFICATION
BACKGROUND AND CURRENT STATUS OF THE TOPIC
BIBLIOGRAPHY
OBJECTIVES
Main objectives
Secondary Objectives
METHODOLOGY
STUDY DESIGN
CALCULATION OF SAMPLE SIZE
SELECTION CRITERIA
EXCLUSION CRITERIA
WITHDRAWAL CRITERIA
VALUATION CRITERIA
ANALYSIS OF RESULTS
DESCRIPTION OF INTERVENTIONS
WORKPLAN
DISSEMINATION AND DISSEMINATION PLAN
ETHICAL ASPECTS OF THE RESEARCH
ANNEXES
Annex 1. Constant scale
Annex 2. DASH scale
Annex 3. TNM classification
Annex 4. Visual Analog Pain Scale
Annex 5. International Physical Activity Questionnaire
Annex 6. EORTC Questionnaire QLQ-BR23
Annex 7. Patient Information Sheet
Annex 8. Patient Informed Consent Sheet
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GENERAL INFORMATION
Document date: 30th October 2021
Main researcher: Jesús Baltasar González Rubiño
Main researcher: Rocío Martín Valero
Main researcher: María Jesús Viñolo Gil
Center where the study will be carried out: Lymphedema Unit of the Sanitary Management Area
Campo de Gibraltar Oeste.
Head of the Lymphedema Unit of the A.G.S. Campo de Gibraltar West: Jesús Baltasar
González Rubiño.
Clinical Research Ethics Committee: This study will be presented to the Research Committee
Provincial.
Contact: Jesús Baltasar González Rubiño
Contact Phones:  856 814 114 / 651 452 494
Contact email: jesusbaltasar@gmail.com
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ABSTRACT
Breast cancer is the most common malignant tumor in women, with more than a million new
cases annually. One of the most frequent surgical and post-actinic sequelae and well known is
postmastectomy  lymphedema.  The  axillary  web  syndrome  is  another  sequel  that  limits  the
functionality of the patient and delays the protocol times of application of treatments cancer, and in
many cases this sequela is misdiagnosed. This surgical sequelusually disappears spontaneously after
the third month of appearance, but this implies a long period of discomfort and limitations for the
user, at the same time that it may delay the application of Radiotherapy within the indicated
protocol deadlines (due to the need for a body posture with abduction and flexion of the affected
upper limb for its application and with the lymphatic thrombus is impossible to get).
With  the  present  quasi-experimental  study,  the  investigator  intend  to  show  that  the
application of Kinesitherapy and stretching from the beginning of the appearance of the cord, in a
controlled and scheduled way by the physiotherapist, it is possible to reduce the time in which the
lymphatic thrombus is present, and therefore, recover functionality, mobility, reduce pain and be
able to apply the patients´ treatments within of the established deadlines. The investigator intend to
apply this therapy in the intervention group and compare thrombus evolution times with the control
group.
QUALIFICATION
Effects of a manual therapy program to reduce the evolution time of axillary web syndrome
in women affected by breast cancer.
BACKGROUND AND CURRENT STATUS OF THE STUDY TOPIC
Breast Cancer is the most common tumor in women around the world, and is one of the
leading causes of death among women in developed countries (1).
It is an important Public Health problem, since according to the World Health Organization
more than a million new cases are diagnosed annually, becoming almost a quarter of malignant
tumors in females (2). In the West, it has been shown that one in nine to twelve women will suffer
from the disease in her lifetime (3).
Most cases occur in postmenopausal women, and the main age at diagnosis is around 60
years (4).
4

After the diagnosis of breast cancer, the patient undergoes surgical and / or cancer treatment.
Chemotherapy, radiotherapy and hormonal therapy are some of the treatment alternatives, which
currently are precisely adapted to the type of tumor seeking a better response and survival (5).
Postmastectomy  lymphedema  is  one  of  the  best-known  postsurgical  and  post-actinic
sequelae after breast cancer, with a prevalence of around 20% of mastectomized women (6). The
conservative treatment of this health problem is based on Decongestive Physical Therapy and
Kinesitherapy (7,8). Pneumatic Multicompartmental Pressotherapy helps reduce the feeling of
heaviness and stiffness of edema (9).
In addition to postmastectomy lymphedema, the patient undergoing surgery for breast
cancer may present  Axillary Web Syndrome (AWS) or superficial lymphatic thrombosis. As
described by W.M. Yeung et al. In their systematic review (10), it can appear in the first eight
weeks after the operation and usually resolves spontaneously within three months of its appearance
(11).
The lymphatic thrombus is clinically manifested as a cord that frequently occurs in the
armpit, although it can also appear along the upper limb, elbow crease even reaching the first finger
(10, 12, 13). Regarding the diagnosis through imaging tests, nuclear magnetic resonance does not
manage to clearly identify the axillary network syndrome, being ultrasound the most reliable
method, due to the dynamism that can be applied to the patient's arm while the diagnostic test is
being carried out ( 12, 14).
The axillary network syndrome produces pain when abducting and flexing the shoulder,
with the respective loss of functionality and limitation of mobility of the affected upper limb (19).
According to the American Cancer Society, radiation therapy is applied 3-8 weeks after the
operation if chemotherapy is not required. If chemotherapy is used, it is applied 3-4 weeks after
completion. It is usually applied 5 days a week from Monday to Friday.
The limitation of mobility often leads to a delay in the application of this useful tool in the
oncological therapeutic arsenal to prevent recurrences (20, 21, 22, 23). Hence, the need and
importance of this study, where the investigator intend to demonstrate that the evolution times of
the lymphatic thrombus can be reduced with assisted passive kinesitherapy and stretching.
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At present, there are some publications that show possible alternatives of physiotherapy
treatment for lymphatic thromb. Many are interventions with a very small sample (even on a case-
by-case basis) (24, 25). Others are observational studies or even studies older than five years. There
are some studies that combine manual lymphatic drainage (Vodder method) with physical therapy
(strengthening, stretching, soft tissue work) with good results (26).
There is ambiguity in the relationship-association between the appearance of lymphatic
thrombosis and lymphedema of the ipsilateral limb. Patients who have developed AWS are 44%
more likely to develop postmastectomy lymphedema (27). There are other studies that do not find a
relationship between the two (28).
The frequency of the AWS is not clear from the current posts. It depends on the type of
surgical intervention, age, BMI (16), the appearance of the postoperative seroma, and even breast
reconstruction (17). Thus being the frequency 30% of the operated patients (10, 18).
After reviewing the relevant literature, it should be noted that there are very few studies and
therefore little evidence on the treatment of AWS. It is not possible to prescript of a clear treatment
in a clinical practice guide for this postsurgical sequela. Most publications highlight the importance
and need for more research to determine the etiopathogenesis and useful treatment for this health
issue (10, 13).
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OBJECTIVES
GENERAL OBJECTIVES
I. Determine a preliminary exploration of the magnitude of the effect of a kinesitherapy and
stretching intervention for the functional recovery of the upper limb, the recovery of the surgical
scar and the improvement of the quality of life in women who have suffered from breast cancer.
II. Create a scale to objectively classify the axillary thrombus (based on its clinical manifestations).
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SPECIFIC OBJECTIVES for general objective I:
- Check the intervention of assisted passive kinesitherapy and stretching for the improvement of the
range of joint mobility of the affected limb in the shortest possible time.
- Analyze the reduction of pain and increase of the degree of functionality of the ipsilateral upper
limb in patients with AWS after the intervention.
-Determine  the  impact  of  the  physiotherapeutic  intervention  on  the  quality  of  life  of  a
mastectomized woman with lymphatic thrombus.
-Analyse the physiotherapeutic intervention reduction of the time on the evolution of the Superficial
Lymphatic Thrombus and the application of Radiotherapy within the terms established in the
oncological protocols.
SPECIFIC OBJECTIVES for general objective II:
- Create a scale to objectively classify the axillary thrombus (based on its clinical manifestations).
METHODOLOGY
TYPE OF STUDY
Quasi-experimental, prospective study.
STUDY POPULATION
The study sample is made up of patients undergoing surgery for Breast Cancer who attend
the Lymphedema Unit of the A.G.S. Campo de Gibraltar Oeste presenting Lymphatic Thrombus
after the operation, the recruitment period being from December 2021 to December 2023.
CALCULATION OF SAMPLE SIZE
To calculate the sample size, the prevalence of axillary network syndrome (AWS) described
in the scientific literature was taken into account. It affects 30%. The 2020 records for patients who
attended the Lymphedema Unit of A.G.S. Campo de Gibraltar Oeste has also been included adding
83 new patients. With these figures, a random sample of 46 individuals in total would be enough to
estimate, with a 95% confidence and a precision of +-5 percent units, a population percentage of
10%.
 
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SELECTION CRITERIA
Patients who meet all the inclusion criteria and no exclusion criteria will be included in this
study prospectively.
INCLUSION CRITERIA
- Patient over 18 years old.
- Mastectomized patients (either radical or conservative surgery).
- Patient with lymphatic thrombus in the upper limb ipsilateral to the surgical intervention.
EXCLUSION CRITERIA
- Significant psychological alterations that would prevent the retrieval of the information necessary
for the investigation.
- Significant neurological alterations that would prevent the retrieval of the information necessary
for the investigation.
- Patients in a situation of legal dispute that would affect their intervention in this study.
- Metastasis not treated with chemotherapy treatment.
WITHDRAWAL CRITERIA
- Withdrawal of informed consent from the patient.
- Administrative decision taken by the researchers, promoter or a regulatory authority.
- Mild adverse event.
- Serious, unexpected or clinically relevant adverse event.
VALUATION CRITERIA
Main Variables:
- Mobility of the affected shoulder, measured by goniometry.
- Functionality assessment using the Constant and DASH scale (29,30).
Secondary variables:
Sociodemographic and clinical-surgical variables
- Age
- Marital status: married or in a common-law relationship, widowed, divorced or separated, single.
- Level of completed studies: illiterate, primary studies, secondary studies, university studies.
- Type of residence: in an urban / rural area.
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- Children: yes / no.
- Mother after 30 years old: yes /no.
- Smoker: yes /no.
- Type of cancer. Four categories have been assessed: ductal, infiltrating, in situ, Paget's.
- Number of lymph nodes removed.
- Type of surgery (radical-conservative).
- Breast reconstruction (yes / no).
- Radiotherapy (yes / no).
- Time from surgery to the appearance of the Lymphatic Thrombus in days.
Clinical Variables:
- Visual Analog Pain Scale.
- Goniometry of all joints of the affected upper limb.
- Record of daily performance of lymphedema prevention kinesitherapy since the operation (days
per week / duration in minutes / day).
- Approximate time elapsed since breast cancer diagnosis: years. Date format dd / mm / yy will be
included, if possible.
- Stage in which the cancer is found, according to the TNM scale.
- Body mass index.
- Creation of a scale to classify the type of lymphatic thrombus (based on its location, length,
thickness, pain, functional limitation and whether it is palpable-visible or not).
Result Variables:
- Level of physical activity measured by the International Physical Activity Questionnaire.
-Quality of life questionnaire EORTC QLQ-BR23
Employment and leisure Variables:
- Employment situation at the time of data collection: Four categories have been assessed: Active /
Retired / Unemployed / Home worker.
- Sport practice: yes / no.
- Sport and frequency.
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Description of the intervention
15 sessions of Assisted Passive Kinesitherapy are carried out by the physiotherapist. Five
days a week, for three weeks. If it is previously referred, the treatment will be finished earlier (the
patient must achieve the same ranges of motion and strength as the contralateral limb, together with
the remission of pain).
The stretches applied during the sessions will be gentle and maintained, never exceeding a
pain grade 5 VAS (moderate pain), once the tension of the cord is reached between 20-30 seconds.
A special effort will be made to recover flexion and abduction of the shoulder, bringing the cord to
a tolerable tension on the part of the patient.
Friction  will  be  made  on  the  axillary  scar  to  dislodge  underlying  planes  and  the
subcutaneous tissue of the muscle fascia.
The patient will be trained in active kinesitherapy to prevent lymphedema and activate
lymphatic circulation. Also with hygienic-postural measures for the same purpose.
CONTROL GROUP
All  the  variables  and  data  for  each  patients  are  recorded  in  their  clinical  history.
Goniometric study will be performed of the affected upper limb (shoulder, elbow, wrist). Constant
scale, Quick-Dash, the Visual Analog Pain Scale and the International Scale of Physical Activity
will also be performed. This assessment will be carried out the patient arrives at our unit and on day
30, 60, 90.
Axillary cord syndrome: It is a nominal qualitative variable. The presence of lymphatic cord
was assessed by observation and palpitation by the assessor. Physical exam performed as suggested
in previous researches: patient laying in supine position with elbow extended and the shoulder in
maximum abduction. The assessor observes and palpates the beads, including the armpit, down the
upper arm from the armpit to the antecubital space and through the forearm to the base of the thumb
(34).
Range of motion: It is a continuous quantitative variable. For the assessment of the mobility
goniometry has been used. Goniometer is the standard instrument for measuring the range of
movement. The patients were asked to move thir arms in flexion, extension, abduction and external
and internal rotation of the shoulder. It was considered that the maximum range of motion for the
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flexion and abduction was 180º, for extension it was 45º, 100º for internal rotation and 80º for
external rotation. Finally, a single index was calculated as the percentage of global movement ().
Constant Scale: According to the Spanish Society for Shoulder and Elbow Surgery (SECHC), the
Constant Scale assesses pain, functionality for daily life activities, joint mobility and shoulder
strength. Also, it considers the laterality and the time it takes the patient. The score ranges from 0
points to 100 points, being 100 the optimal condition for the shoulder. (35, 37).
Quick-Dash  (
 
 DASH)
 
 :  The  Disabilities  of  the  Hand,  Arm  and  Shoulder  (DASH)
questionnaire is a specific instrument for measuring the quality of life related to health problems to
the upper limbs. It is validated in Spanish and it consists of 30 questions. The final score calculation
is relatively complicated. In order to calculate the scores it is necessary to have answered at least 27
out of the 30 questions. The final scores is obtained by calculating the arithmetic means of the
questions answered minus 1 times 25.  The DASH questionnaire has excellent reproductibility and
high sensitivity, being able to detect small changes. The scale ranges from 30 to 150 points. 30
points means good shoulder functionality and 150 non-functional shoulder
It has two optional subsections where sports and work functionality can be assessed (38).
Visual Analog Pain Scale (
 
 VAS)
 
 :   According to the National Cancer Institue ( NIH), it is a
tool used to help the professional assess the intensity of certain sensations and feelings, such as
pain. The Visual Analog Scale for pain is composed of a straight line on which an extreme means
no pain and the other extreme means the worst pain imaginable. Extreme pain corresponds to 10
points. None pain corresponds to 0 points.
The patient marks a point on the line that matches the amount of pain they feel. Also known as VAS
(36).
International Scale of Physical Activity (
 
 IPAQ)
 
 :  The main use of the IPAQ (International
Physical Activity Questionnaire) worldwide is aimed at monitoring and investigation purposes. It is
an instrument designed mainly for the “monitoring” of physical activity performed  by the adult
population and their perception of their health. Its aim is to learn about the kind of physical activity
that people do as part of their daily activities. The questions are focused on the time the patient
spends being physically active during the previous 7 days. The patient should consider the activities
he/she does as part of work, garden, at home, leisure, moving from one place to another during their
rest, exercise or sport. 
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IPAQ is scored by comparing the OMS recommendations. For the group of adults from 18
to 64 years old, it is done as follows: perform at least 150 minutes per week of moderate physical
activity, or 75 minutes per week of vigorous physical activity, or an equivalent combination of both,
that is, between both intensities they add up to at least 150 minutes of physical activity per week.
The patient must answer each question in minutes a week (39).
EORTC-QLQ-BR23 questionnaire: It consists of a validated questionnaire consisting of 30
questions. The first 28 questions are scored from 1 to 4, with the highest values being those that
show greater difficulty when carrying out the activity for which they are asked or the worst state of
health. 126 points is the highest score and means excellent health. 0 points means the worst health. 
Finally, there are two general questions about the state of health and quality of life that score
from 1 to 7, the highest value being the best state of health and quality of life. The vast majority of
questions refer to the previous week (40).
Barthel Scale: The Barthel index or Barthel scale is an instrument used by social and health
professionals for the functional assessment of a patient and to monitor their evolution. In the case of
Social Workers, they value the independence or dependence of the person in each of the activities
of daily living (ADL), obtaining as a result the level of performance of the person and carrying out
a rehabilitative / compensatory intervention and / or maintenance according to the results obtained.
Promoting and / or maintaining the independence of the person.
The scale measures the ability of a person to perform 10 activities of daily life, which are 
considered basic, in this way a quantitative estimate of their degree of independence is obtained. 
100 points is the highest score and the best result in the patient's functionality. 0 points is the worst 
result and shows the worst functional status.
These  patients  will  be  instructed  in  hygienic-postural  care  and  active  assisted  auto-
kinesitherapy to perform daily for 30 minutes. It will be assessed every 30 days (see exercise
pictures).
These exercises are explained to the patient to be executed at home.
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Exercise 1.- Codman Pendulum exercises.
Exercise 2.- Standing, Affected shoulder flex sliding palm of the hand on the wall up and down.
Keep maximum flex during 15 seconds.
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Exercise 3.- Seated,  Affected shoulder flex. Seated on a wheeled chair, leaning elbow on a table.
Shoulder flex sliding chair backwards and forwards.
Lymphedema  prevention  exercises.  (please  visit  our  YouTube  channel  “Unidad  Linfedema
Algeciras”: https://www.youtube.com/channel/UC2usHZkrmgyDfEsKhBWKrmw
INTERVENTION GROUP
As well as the control group, all the variables and data for each patient will be collected in
their medical history. Goniometric study of the affected upper limb will be performed too (shouder-
elbow-wrist). Constan scale, Quick- DASH, Visual Scale will also be completed together with
Analogue of Pain and the International Scale of Physical Activity. This exploration will also take
place during the first session and on the 30th, 60th and 90th day.
These users will arrive at the first diagnosis of the thrombus in our unit,in order to receive
manual therapy by the physical therapist. (see therapy pictures).
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They will receive 15 sessions of manual therapy the physiotherapist, 5 days a week ,each
session being approximately 40 minutes long.
The session will begin with pendulum exercises of the shoulder to warm up the joint and
give proprioceptive stimulation to the joint capsule.
The physiotherapist will perform passive stretches looking to tensioning the lymphatic cord,
never exceeding grade 6 VAS pain chart. Mainly the affected shoulder will be treated and if the
cord reaches the crease of the elbow or thumb, the extension (frase sin sentido general hay que
volverla a escribir).
Scar massage will be done in the area where the lymphatic cord originates at the proximal
level while maintaining the tolerable tension of the lymphatic cord (during the massage also pain
grade 6VAS will be exceeded).
Patients with developed lymphedema will receive Decongestive Physical Therapy (PDT) on
the treated limb once the 15 day treatment described for the study is finished. Therefore, PDT does
not influence on obtained contaminated results. Those patients who do not suffer from lymphedema
do not receive PDT.
Manual Therapy, Scar Massage and exercises for the Intervention Group:
Exercise 4.- The Physiotherapist rests the affected limb diagonal to regular movement only if pain
due to stretching is moderate.
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Exercise 5.- The Physiotherapist rests the limb in shoulder flex following elbow extension.
Exercise 6.- The Physiotherapist places the limb in abduction position while patient can tolerate
discomfort.
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Exercise 7.- In case the cord reaches the elbow, the Physiotherapist holds the elbow extension
combined with supination of the limb. The shoulder will be kept in flexed position as long as pain is
moderate to keep the tension of the cord. 
Exercise 8.- If the thrombus reaches the first finger, the Physiotherapist will try to reach the ulnar
deviation of the wrist together with the flexion of the thumb. The shoulder will be kept in a flexed
position and the elbow in an extended supination position.
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ANALYSIS OF RESULTS
A descriptive analysis of all the variables included in the study will be presented at the
overall level and by type of treatment in the Axillary Web Syndrome. For the qualitative variables,
the relative and absolute frequencies will be presented. In the case of quantitative variables,
summary statistics will be presented (mean, median, mode, minimum and maximum).
For all study objectives in which two qualitative variables are related, the non-parametric
Chi-square test will be used and, if necessary, the Fisher test will be used (in cases where the
absolute frequency of more than 20% of the levels is less than 5 observations). To quantify the
possible predisposing factors, the relative risk measures (RR), Odds ratio (OR) and their associated
confidence interval will be obtained; Likewise, the sensitivity or specificity will be presented if it is
considered necessary.
All analyzes will be accompanied by graphic representations for greater detail. Missing
values will be those that are not completed.
All analyzes will be carried out with free R software and the significance level for all
hypothesis testing is determined at 0.05.
WORKPLAN
The study will be carried out according to the following schedule:
Development and approval of the Provincial CEIC
OCTOBER 2021
Beginning of the recruitment period and action on the intervention group
DECEMBER 2021
Drafting of results, discussion and conclusions of the project
DECEMBER 2023
According to the schedule set forth, the research project will be completed in a period of 24
months.
The researcher Jesús Baltasar González Rubiño will register the patients, whether they are in
the control group or in the intervention group. The physiotherapy intervention will be applied
during 12 sessions from Monday to Friday to the selected patients.
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The researcher María Jesús Viñolo will be in charge of comparing the results with a double-
blind system and thus comparing the results of the control group with the intervention group. The
researcher Rocío Martín Valero will be the methodological advisor in this research.
Jesús Baltasar, with the help of María Jesús Viñolo and Rocío Martín Valero will write the
results, discussion and conclusions of the project.
DISSEMINATION AND DISSEMINATION PLAN
1. Publication in journals indexed in the Journal Citation Report (JCR), in the field of Oncology and
Rehabilitation and Physical Medicine and Physiotherapy.
2. Dissemination of results in national and international Congresses of Oncology and Rehabilitation
and Physical Medicine and Physiotherapy.
3. Dissemination to the public, press releases and explanatory brochures of the project.
4. Dissemination on the website of the A.G.S. Campo de Gibraltar West.
ETHICAL ASPECTS OF THE RESEARCH
The ethical aspects of this study are included in Law 41/2002, on Patient Autonomy and
Rights and Obligations Regarding Information and Clinical Documentation, as well as in Law
14/2007, on Biomedical Research. The personal data obtained during the study will be treated in
accordance with the provisions of Organic Law 3/2018, of December 5, on the Protection of
Personal Data and Guarantee of Digital Rights, as well as in compliance with the General Data
Protection Regulation (EU ) 2016/679.Before starting the data collection, the assessment and the
mandatory  favorable  report  will  be  requested  from  the  Research  Ethics  Committee,  on  the
methodological, ethical and judicial adequacy of the research. Sensitive data (such as NUHSA,
other identifying data, etc.) will be encrypted to preserve confidentiality. Both the coding system
and the databases extracted will be kept in a single device with an access key only known by the IP.
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ANNEXES
Annex 1. Constant scale
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Annex 2. DASH scale
26

Annex 3. TNM classification
Annex 4. Visual Analog Pain Scale
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Annex 5. International Physical Activity Questionnaire
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Annex 6. EORTC Questionnaire QLQ-BR23
Annex 7. Patient Information Sheet
INFORMATION SHEET FOR THE PARTICIPANT IN A CLINICAL RESEARCH STUDY
Study title: Effects of a manual therapy program to reduce the evolution time of axillary network
syndrome in women affected by breast cancer.
Main researcher: Jesús Baltasar González Rubiño, belonging to the Algeciras Lymphedema Unit.
Participating center: Algeciras Lymphedema Unit.
INTRODUCTION
The patients are invited to participate in a study that has been approved by the Cádiz Clinical
Research Ethics Committee.
Please read this fact sheet carefully. The physiotherapist Jesús B. González Rubiño will clarify any
doubts that may arise.
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VOLUNTARY PARTICIPATION
The patients´ participation in this study is voluntary and the patient can override their decision and
withdraw their consent at any time, without thereby altering their relationship with the doctor or
damaging their treatment or the care the patients may need.
GENERAL DESCRIPTION OF THE STUDY
The objective of this study is to reduce the time of evolution of the Postmastectomy Lymphatic
Thrombus.
Registration and initial clinical assessment of the patient will be made. The Upper Limb affected by
the lymphatic cord will be treated with Assisted Passive Kinesitherapy and Stretching.
This lymphatic thrombus, according to the scientific literature, has a spontaneous resolution in
approximately 3 months from its appearance. With this study the investigator intend that it take less
time to disappear. Likewise, the investigator intend to reduce pain, improve shoulder mobility and
improve the functionality of the affected arm.
46 patients / subjects will participate in this study.
BENEFITS AND RISKS DERIVED FROM PATIENTS´ PARTICIPATION IN THIS STUDY
Without  the  existence  of  any  risk,  the  information  obtained  will  serve  to  expand  scientific
knowledge about breast cancer recurrences. The patient will not get any health benefits from
participating in this study.
ECONOMIC COMPENSATION
The patient´s participation in the study will not incur any cost to her.
CONFIDENTIALITY
The patient´s data will be treated with the utmost confidentiality in accordance with the provisions
of Organic Law 3/2018, of December 5, on the Protection of Personal Data and guarantees of digital
rights and the General Data Protection Regulations. According to what is established in these.
Rules, the patient can exercise the rights of access, rectification, opposition, deletion, limitation of
release, right to be forgotten and portability, for which the patient should contact the researcher
responsible for the study, Mr. Jesús Baltasar González Rubiño. 
Email: jesusb.gonzalez.sspa@juntadeandalucia.es. Telephone: 856814114.
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If the results of the study are published, patient´s personal data will not be published and the
patient´s identity will remain anonymous.
FINANCING
First study does not have any source of funding.
WITHDRAWAL OF CONSENT
The patient can withdraw their consent at any time without having to give explanations
If the patient no longer wish to participate in the study and the patient do, all patient´s identifiable
responses will be destroyed.
The patient should also know that the patient can be excluded from the study if the study the
investigators see fit.
The patient has the right to be informed of any retesting of the identifiable material withheld not
provided for in this study. In that case, the researcher will have to ask the patient for a new consent
that the patient could refuse.
Before signing, read the document carefully, ask all the questions the patient consider appropriate,
and if the patient wish, consult it with all the people the patient consider necessary.
If in doubt, the patient should contact Jesús Baltasar González Rubiño.
SIGNATURES
Patient Company:
 Investigator Company:
Name:
Name:
Date: 
Date:
First document  should be signed in duplicate:  one copy for the participant  and one for the
researcher.
Annex 8. Patient Informed Consent Sheet
WRITTEN INFORMED CONSENT
Study title: Effects of a manual therapy program to reduce the evolution time of axillary network
syndrome in women affected by breast cancer.
Promoter: Jesús Baltasar González Rubiño.
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I (name and surname) ________________________________________________________
I have read and understand the information sheet provided to me.
I have been able to ask questions about the study.
I have received enough information about the study. I have spoken with:
____________________________________________________________________________
(name of researcher)
I understand that my participation is voluntary.
I understand that I can withdraw from the study:
1 When the patient wants to.
2º Without having to give explanations.
3rd Without this affecting my medical care.
I freely give my consent to participate in the study.
DATE AND SIGNATURE OF THE PARTICIPANT
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