Comparision of Hydrodilatation Results at Different Volumes in Adhesive Capsulitis by Phases.
Phase: NA
Conditions: Capsulitis of Shoulder, Hydrodilatation
Sponsor: Javier Muñoz Paz

 
1 
 

 
1 
 
 
 
DEPARTMENT: M. PHYSICS AND REHABILITATION 
 
1. Starting hypothesis 
 
Adhesive capsulitis (AC) is a very common condition seen in Physical Medicine and 
Rehabilitation clinics. In most cases, its progression is self-limiting. However, during this 
time, the patient experiences pain and daily functional disability.  
 
The diagnosis depends primarily on clinical data focused on pain and both active and 
passive functional limitation. The use of imaging tests is more aimed at ruling out pathologies 
that can cause similar symptoms.  
 
Until recently, treatment focused on oral medication, corticosteroid injections for pain, and 
physical therapy (PT) to prevent further shoulder limitation. With the advent of the 
hydrodilation (HD) technique, the progression of the disease can be shortened.  
 
Although this type of technique is increasingly used, its protocolization as a second-line 
treatment has not yet been possible. The wide variability in the performance of the technique 
may be one of the reasons. Within this variability, the volume required to consider this 
technique optimal is a matter of debate. 
 
 
Initial hypothesis: Patients with AC, depending on the stage of development, who receive 
high-volume HD as treatment, obtain better results in the Shoulder Pain and Disability 
Index test (SPADI), the visual analogue scale (VAS) and the joint range of motion (ROM) 
at the first, third and sixth month of therapy, compared to patients who receive low-volume 
HD in the general population. 
 
 
 
2. Background and previous results 
  
 AC, also known as frozen shoulder, is defined as a condition in which a <global limitation of 
active and passive movement of the shoulder progressively develops, which may or may 
not be associated with pain, without other radiographic findings to justify it= (1). The 
prevalence of this pathology is around 2 - 5% in the general population (2), with an age of 
onset between 40 - 60 years (3) and being up to four times more frequent in women (2,4). 
 
RESEARCH PROJECT – HYCAFVOL – Version 2 (01/02/25) 
COMPARISON OF HYDRODILATION RESULTS AT DIFFERENT VOLUMES IN 
ADHESIVE CAPSULITIS BY PHASES 

 
2 
 
Regarding the historical course of this disease, the clinical picture was first described in 
1872 by Duplay. Codman later named it "frozen shoulder" in 1934 (5). Neviaser later named 
it AC in 1945 (6) and described its pathophysiological process. 
 
This disease, with an average duration of 1-3 years (3), is a self-limiting process (4,5) that 
can be divided into three (2,4) or four (5,6) main phases, depending on the literature. 
 
1st Freezing Phase (0–9 months): Increasing diffuse and disabling pain, mostly at 
night, associated with mild stiffness. This phase includes the pre-freezing phase (0–
3 months), with symptoms of very mild pain and stiffness. 
 
2nd Stiffness Phase (9–15 months): Significant stiffness across all ranges of 
motion, accompanied by a progressive decrease in pain. 
 
3rd Thawing Phase (15–24 months): Gradual return of joint balance without 
associated pain. 
 
Among the predisposing factors are gender due to estrogens (7), diabetes mellitus due to 
hyperglycemia (8) and thyroid diseases (9), all of them related to the creation of a chronic 
proinflammatory state that favors the appearance of AC. This chronic inflammation promotes 
the presence of inflammatory cells such as fibroblasts, B lymphocytes, cytokines, 
interleukins such as IL-6 or tumor necrosis factor alpha, which in turn from a histological 
point of view favor the appearance of fibrosis, proliferative synovitis and capsular thickening 
(2,4). 
 
The pathological findings appear to be related to the phases of AC, with hypervascular and 
hypertrophic synovitis with fibroplasia and perivascular scarring being more common in 
phase 1; and hypercellular tissue accompanied by extensive fibroplasia but with a thin 
synovial membrane and without hypervascularity or synovitis being more common in phase 
2. (10) 
  
At present, the general consensus regarding the diagnosis of AC is a section still to be 
developed due to its difficulty (11). This has been based so far on fundamentally clinical 
aspects such as pain, and limitations of the ROM (3–5,12). The limitation of ROM both in 
active and passive is a data considered pathognomonic (2,4), with a limitation of external 
rotation (ER) (3–5) and abduction (ABD) (12) mainly. However, in a pathology in which the 
clinical stage in early phases seems to be associated with the need for shorter recovery 
times (13), as concluded in the systemic review by Schiltz M et al, its diagnosis should be 
based on more precise <diagnostic tools= in addition to a clinical pillar (12). 
 
Currently, the two most commonly used diagnostic imaging tests to rule out pathologies that 
may resemble AC (rotator cuff tendinopathies, acromioclavicular osteoarthritis, labral injury, 
etc.) (2) would be magnetic resonance imaging (MRI) and ultrasound (US). 
 
Regarding MRI, although there is no consensus yet, this test provides parameters that may 
be useful in cases of contradictory exploration (14). However, if we think about the long 

 
3 
 
waiting lists, the need for several appointments to associate clinical symptoms with images 
and perhaps the most devastating data associated with the study carried out by Dimitris MD 
et al in which it is stated that "the routine use of shoulder MRI scans in patients with AC but 
without suspicion of an additional pathology may not be indicated", because "37 MRIs were 
necessary to change a single therapeutic plan" (15) makes us think that MRI may not be the 
diagnostic tool we are looking for. 
 
Quite the opposite occurs with the use of ultrasound. The possibility of performing it at the 
same time as the consultation, the high availability for many specialties, the low cost and 
the good diagnostic accuracy (11) make this test a great possibility of diagnostic support in 
AC. Within the ultrasound parameters related to AC, the measurement of the thickness of 
the axillary recess (AR) is a piece of data that, as shown in the study by Byung Chan L et 
al, seems to correlate significantly with pain, functionality and ROM (16). The average scores 
that are taken as a reference to determine whether or not AC may exist, would be to find, 
together with clinical data, an AR of ≥ 4 mm, although more studies are needed to 
demonstrate this (11,16,17). 
 
We now focus on possible treatments. Previously, the concept of "benign neglect" (13) was 
used, which referred to allowing the disease to progress given its self-limiting nature. 
However, other conservative treatments are now emerging that may be useful in AC. These 
include physical therapy, intra-articular corticosteroid injections, suprascapular nerve block, 
and HD (2,13,18–20).  
 
Focusing on the latter, the procedure was first described in 1965 by Andren and Lundberg 
(21). HD consists of an ultrasound-guided procedure in which a volume of fluid (saline, 
anesthetic and corticosteroid) is injected to cause expansion of the joint capsule, which is 
already rigid (19,22). 
 
As early as 2008, Cochrane concluded that HD was a useful tool in AC, but that it did not 
provide improvement in terms of pain and disability for more than 3 months (23). The 
medium- to long-term role of this technique remains a topic of discussion due to the 
enormous "evidence gap" that exists (24). 
 
Most of the studies reviewed for this study show a heterogeneous pattern regarding the 
results of this technique and its comparison with intra-articular injections. Some of them 
conclude that HD has "comparable efficacy to intra-articular corticosteroid injections" (25). 
However, studies are beginning to appear that demonstrate its long-term benefits, such as 
the study by Sofía Dimitri-Pinheiro et al., which concludes that "it is effective in improving 
shoulder pain and increasing disability... with benefits lasting up to 2 years" (26). 
 
The difficulty in finding consistent results using this technique may arise from its lack of 
protocolization. This is why this essay focuses on various points of conflict. 
 
The first of these is the differences in relation to the volume needed to achieve optimal 
capsular expansion. A study carried out in 2020 by Jang Hyuk Cho concluded that the 
optimal volume to achieve such expansion was around 18 ml (27). This amount of volume, 

 
4 
 
or close to it, appears in later studies on HD (28,29). However, we also find later studies 
where they talk about <variable volumes= (26), and even higher volumes, typically 30-40 ml 
(30), or like the one carried out by Magdalena Pimenta et al in which it is discussed that a 
volume of up to 47 ml (31) allows capsular expansion without risk of rupture, data related to 
worse results (27,31). 
 
The combined use or not of other therapies with HD, such as suprascapular nerve block 
(SSNB) and PT, are also topics of interest, however their use is increasingly common and 
seems to be little discussed. In the case of SSNB, its use has been associated with additive 
improvements in both pain and shoulder function (18,32), being in many cases "a valuable 
complementary therapy" (33). In the case of PT, its use in the first line of treatment (20) is 
more than established in clinical practice. Most studies show that PT is a very useful 
complementary treatment (34). 
 
The second important point, not so much due to the scientific discussion, but rather due to 
the absence of this variable in the reviewed studies, is the lack of stratification by phase of 
the disease. Considering the relationship between clinical phases and pathological findings, 
the fact that studies on HD from 2019 to the present are reviewed and most do not 
differentiate these results according to the phase of AC (18,22,25,26,29–31) does not make 
much sense. Only in the study by Fabio Vita et al. in 2024 is a differentiation made between 
the results obtained in both phase 1 and phase 2 (28). If we take into account everything 
previously stated, the variability between HD techniques, the lack of phase stratification in 
the results, the diagnostic difficulty and above all <high quality scientific work= (35), it is 
normal that the most repeated conclusion is the need to carry out more studies in order to 
be able to protocolize this treatment (18,20,25,30). 
  
 
 
3. Main and secondary objectives 
 
            1. Primary Objective: 
 
• To demonstrate the variability in SPADI, VAS, and ROM results among 
patients receiving HD at different volumes. 
 
2. Secondary Objectives: 
 
• To determine whether there are differences in time to physical therapy 
discharge among patients receiving HD at different volumes. 
• To determine whether the overall results differ when stratified by AC stage. 
• To determine the mean values that AR can present in AC. 
 
 
4.   Study design 
 
Design: A parallel block randomized clinical trial with triple blinding is proposed. 
 
 

 
5 
 
Study population, variables and inclusion-exclusion criteria 
 
 
Inclusion Criteria: 
 
- Patients aged 30-70 years. 
- Shoulder pain lasting more than 3 months. 
- Limited ROM, both active and passive. 
 
Exclusion Criteria: 
 
- Lidocaine + test with improved ROM. (4) 
- Conditions that preclude treatment (active cancer, tissue infection, oral 
anticoagulant therapy, cardiac arrhythmias, etc.) 
- Previously receiving HD treatment in less than 1 year. 
- Stage 0 or 3 AC. 
- Non-adherence to the FST program, with attendance rates exceeding 20%. 
- Presence of conditions that can cause similar symptoms, such as acromioclavicular 
osteoarthritis, labral injury, massive rotator cuff tear, or rheumatic diseases. 
- Intra-articular corticosteroid injections for less than 2 months. 
 
Clarifications regarding diagnosis and staging by phases 
 
In order to establish consistent diagnostic criteria and facilitate staging of AC, the selection 
process will be based on the following points. 
 
Regarding the diagnosis, the ROM limitation must be affected in two planes, one of which 
must be the RE and/or ABD. These ROMs will be considered limited if they are reduced by 
30% or more (3,22,36,37). 
 
If there is any doubt as to whether the limitation may be due to a blockage caused by the 
patient to prevent pain, a lidocaine test will be performed (3,4). This consists of injecting 5–
10 cc of 1% lidocaine into the subacromial space to facilitate passive examination of the 
joint. It will be considered positive if a release of ROM and a reduction in pain are found after 
its use. 
 
Staging in phases will be performed according to the information provided in section 1.1 
Background and justification. Patients in stage 1 will be considered those in whom the 
predominant symptom is pain accompanied by limited ROM, and patients in stage 2 will be 
those in whom limited ROM predominates over pain. Patients with intermediate symptoms, 
in whom both pain and limited ROM are present, will be classified based on the chronology 
of the disease, with the midpoint between the two stages being considered at 9 months of 
disease progression. 
 
Variables to take into account: 
 
• SPADI (22,38,39). 
 
The Shoulder Pain Disability Index is a widely used outcome measure that provides 
information about shoulder pain and limitations. 
 
o Pain Scale 
 

 
6 
 
How severe is the pain? 0 = no pain and 10 = the worst pain imaginable. 
 
- At its worst? 
- When lying on that side? 
- When reaching for something on a high shelf? 
- When touching the back of your neck? 
- When pushing with the affected arm? 
 
o Disability Scale: 
 
How much difficulty do you have? 0 = no pain and 10 = the worst pain imaginable. 
 
- Washing your hair. 
- Washing your back. 
- Putting on a T-shirt or sweater. 
- Putting on a button-down shirt. 
- Putting on your pants. 
- Placing an object on a high shelf. 
- Carrying a heavy object weighing 4.5 kilograms. 
- Reaching out of your back pocket. 
 
Then, pain and disability are separately recorded, and a percentage of impairment 
is combined. 
 
This index has demonstrated "good internal consistency, convergent validity, and 
reliability" in its Spanish version, making it one of the most reliable measurement 
instruments in the field of shoulder disorders today. 
 
• VAS (28,40,41). 
 
The VAS "is a validated subjective measure for acute and chronic pain." It allows for 
the measurement of pain intensity with maximum reproducibility. 
 
It consists of a 10-centimeter horizontal line, with the extreme expressions of a 
symptom at each end. To the left (0) is the absence or lowest intensity, and to the 
right (10) is the highest intensity. The patient is asked to mark the point on the line 
that indicates the intensity. The minimally detectable differences for the symptom 
level to be acceptable are 2 to 3 points. 
 
• ROM (21,42). 
 
Range of motion assessment is a basic practice in the study of shoulder pathologies, 
especially in the case of AC. ROM should be measured, both actively and passively. 
 
The ROMs that will be assessed actively and passively will primarily be flexion, 
abduction, external rotation (with the arm at 90° of abduction, by asking the patient 
to show us the palm of their hand), and internal rotation (with the arm at 90° of 
abduction, by asking the patient to show us the back of their hand). All of these are 
measured with the PLURIMETER inclinometer. 
 
The measurement will be performed with the patient actively seated, and if limitations 
are found, the patient will be placed supine to eliminate the influence of gravity. 

 
7 
 
• LATTINEN (43) 
 
The Latineen test is a widely used tool for pain assessment, validated in Spain as a 
tool to measure the degree of pain in patients with chronic pain. This scale consists 
of five items scored from 0 to 4: 
 
1. Pain intensity. 
2. Pain frequency. 
3. Analgesic use. 
4. Degree of disability. 
5. Hours of sleep. 
 
Although this test is widely used in chronic pain conditions, its use in AC is not very 
common. However, we believe it can provide important data such as analgesic 
medication intake. This is why we consider its use appropriate. 
 
• AR SIZE (16,44) 
 
It will be measured using ultrasound with a longitudinal section of the AR. The patient 
will be placed supine with the shoulder abducted at 90° and the elbow flexed. 
 
• TIME FROM START TO END OF PHYSIOTHERAPY. 
 
The following criteria will be established for discontinuing PT treatment: 
 
- Failure to improve ROM by 15% after full HD after 16 sessions. 
- Recovery of full ROM after 4 sessions. 
- Increased pain that precludes PT. 
- Maximum of 24 PT sessions. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Variables 
Initial 
Consultation Intervention 1 Month 3 Months 6 Months 
Age 
× 
 
 
 
 
Gender 
× 
 
 
 
 
Previous Treatments 
× 
 
 
 
 
Diseases 
 
 
 
 
 
Time Since Clinic Start 
× 
 
 
 
 
AR Size 
× 
 
× 
× 
× 
SPADI 
× 
 
× 
× 
× 
VAS 
× 
 
× 
× 
× 
ROM 
× 
 
× 
× 
× 
Lattinen 
 
 
× 
× 
× 
PGI - I 
 
 
 
 
× 
CGI - C 
 
 
 
 
× 
Time from Start to End of FST 
 
 
 
 
HD Repetition 
 
 
 
 
Table 1: Variables collected chronologically according to successive consultations 

 
8 
 
Interventions 
 
Type of intervention 
 
- 
- HD technique with a 20 ml volume. 
- 
- HD technique with a 40-50 ml volume. 
 
Assignment to interventions 
 
The allocation process will be pre-established and random. This assignment will be carried 
out using an algorithm created in an Excel database. This assignment will be known only to 
Javier Muñoz (JMP), who will safeguard the information until the end of the study to avoid 
interfering with the results obtained and thus avoiding potential bias. 
 
Execution of interventions 
 
It is proposed to perform HD techniques at different physiological saline solution 
(SSF) volumes. To do this: 
 
- 
First, an ultrasound-guided suprascapular nerve block (SSNB) will be performed with 
4 ml of 0.25% anesthetic + 0.5 ml of corticosteroid in the suprascapular notch. 
 
- 
- After 15 minutes of the SSNB, ultrasound-guided HD will begin. To do this, the 
patient will be placed in a lateral decubitus position on the unaffected arm. The arm 
to be treated will be positioned at the patient's side without forcing its extension. The 
joint cavity will then be approached posteriorly, introducing a spinal needle in the 
ultrasound plane between the humeral cortex and the labrum. The joint cavity will 
then be confirmed by introducing physiological saline solution and observing its 
reflux by pushing the plunger. Subsequently, 5 ml of 0.25% anesthetic + 0.5 ml of 
corticosteroid will be introduced, and then the corresponding predetermined volume 
will be topped up with saline solution. 
 
- 
Variability in the volume used in each HD is a constant within this technique. The 
volumes proposed above, as explained in section 2. Background and previous 
results, are those used to obtain optimal results, without posing any risk to the 
patient, as they do not involve any change in the usual practice of this technique. 
 
- 
Finally, gentle release manipulations will be performed passively without forcing 
pain. 
 
 
PT protocol after HD 
 
PT treatment will begin 3 to 5 days after HD. The patient will visit twice a week. 
 
Patients will be treated exclusively with manual techniques and kinesitherapy. They will be 
given manual techniques to release joint balance and will be instructed on exercises adapted 
for both the gym and home use. Exercises that cause pain will be avoided. 
 
• Active kinesitherapy: 4 sets of 10 repetitions (rest between 30 seconds and 1 
minute between sets) twice a week. 
 

 
9 
 
•  Manual therapy: 
 
- Fascial release of the cervical and scapular areas. Axial and lateral 
coaptation tractions with a strap. 
- Mobilization with manual resistance through all ranges of motion. 
- Post-isometric stretches through all ranges of motion, emphasizing 
restrictions. - 5-second contraction with repetitions of 5 times for each muscle 
group. 
 
Risks and discomfort of interventions 
 
The techniques used and medications described above are included within approved and 
approved indications for use in our setting. This type of technique is a common treatment 
for your condition. 
 
Regarding the potential risks that may be encountered, we state the following: 
 
Frequent 
 
- 
Infiltration may cause mild local reactions such as redness and pain, which disappear 
within a few days without the need for additional therapeutic measures. Early, 
transient facial flushing is common. 
- 
Adverse effects associated with corticosteroids may occur (elevated blood glucose, 
elevated blood pressure, and subcutaneous tissue atrophy). 
 
Uncommon 
 
- 
Allergic reactions (ranging from minor symptoms to anaphylactic reaction) to any of 
the injected components. Therefore, if you know of any known allergies, you should 
inform your doctor before administration. 
- 
Tendon injury, including rupture, near the injection site. Infection at the injection site. 
- 
Temporary depigmentation of the injected area. 
 
Risks related to the patient's clinical condition. 
 
- 
It is essential to ensure that there is no pregnancy in women of childbearing age. 
- 
This treatment is contraindicated in patients with pacemakers, infections, or tumors 
located in the injection site. 
 
Benefits of Interventions 
 
The potential benefits of this type of therapy focus on pain reduction and a return to 
functionality as close to the patient's previous condition as possible. All of this, therefore, 
would entail indirect benefits such as reduced painkiller use, improved sleep, and so on. 
 
It's possible that you won't obtain any health benefits at all. 
 
Alternative Treatments 
 
Available alternatives include oral medication, physical therapy alone, and debridement 
surgery. 
 
 

 
10 
 
Financial Expenses and Compensation 
 
You will not have to pay for medications or specific study tests. Your participation in the 
study will not incur any additional costs beyond your usual clinical practice. 
 
The technique performed is a standard procedure in the clinical practice of this type of 
pathology. 
 
Sample size (22,38) 
 
Two studies using the SPADI scale in AC were used for the sample calculation. An average 
was calculated using the necessary values (standard distribution and minimum difference 
to be detected) for this calculation. Therefore: 
 
Accepting an alpha risk of 0.05 and a statistical power greater than 0.8 in a two-tailed 
contrast, 16 subjects are required in group 1 and 16 in group 2 to detect a difference equal 
to or greater than 15 units. The common standard deviation is assumed to be 14. A 20% 
loss to follow-up rate has been estimated. 
 
Work plan 
 
The recruitment and results collection process will consist of the following phases: 
 
1st Recruitment and Interventional Treatment (JMP) Phase: In this first phase, patients 
referred to the Physical Medicine and Rehabilitation Service will attend an initial screening 
consultation to confirm the diagnosis of AC and that they meet the established 
inclusion/exclusion criteria. 
 
In this initial consultation, the protocol will be explained to the patient, the specific informed 
consent form will be signed, and the variables listed in Table 1 will be collected. 
Subsequently, patients will be scheduled for the Interventional Rehabilitation Consultation 
for H. The necessary variables will be collected again, and they will be referred to FST 
through the mechanisms and means created for this purpose. 
 
2nd Physical Therapy Treatment Phase (Amin Wahab (AW) and Francisco Espinosa 
(FE)): Referred patients will begin the FST program in less than 3-5 days. The FST start 
and discharge date will be recorded according to pre-established criteria. 
 
3rd Review Phase (Ana Belén Jiménez (ABJJ)): Periodic reviews will be conducted at 1, 
3, and 6 months after the intervention to collect the corresponding variables. 
 
4th Phase: The collected information will be synthesized and entered into SPSS software 
to obtain results. The following actions will be carried out: 
 
 
 
Primary outcomes: SPADI, EVA, ROM, Lattinen. 
Grouping outcome: 20 ml HD vs. 40 ml HD 
 
 
 
 
 

 
11 
 
 
AC phase I 
 
 
 
 
 
 
 
 
 
 
 
AC phase II 
 
 
 
 
 
 
 
 
 
 
 
 
• 
For an independent data design: 
 
- 2 groups: Student's t-test or Mann-Whitney U-test. 
- More than 2 groups: Analysis of variance or Kruskal-Wallis H-test. 
 
• 
For a paired data design: 
 
- 2 groups: Student's paired t-test or Wilcoxon test. 
- More than two groups: Repeated measures analysis of variance or Friedman 
test. 
 
Pearson's Linear Correlation Coefficient (r) will be used to correlate two quantitative 
variables. A test (Bonferroni, Finner, etc.) will always be used for multiple comparisons to 
correct the "p" value. Multiple Linear Regression Analysis will be used for multiple analyses. 
 
All contrasts will be two-tailed, and those with a P <0.05 will be considered significant. Data 
will be collected, processed, and analyzed using SPSS v.24. 
 
Masking 
 
The study is planned as a triple-blind study, with only the allocation information, as described 
in the previous section, known to JMP. No other team member, neither the patient nor the 
statistician, will have any knowledge of the treatment assignment. 
 
 
 
 
 
32n
HD 20ml 
HD 40ml 
SPADI 
16n 
16n 
 
 
16n 
16n 
16n 
16n 
SPADI 
SPADI 
SPADI 
Vs 
Vs 
Vs 
 
 
32n
HD 20ml 
HD 40ml 
SPADI 
16n 
16n 
 
 
16n 
16n 
16n 
16n 
SPADI 
SPADI 
SPADI 
Vs 
Vs 
Vs 

 
12 
 
 
Data collection and management 
 
The data obtained from the reviews conducted during the study will be stored in the Diraya 
system. From there, JMP will enter the data into a database, without patient identification, 
in the SPSS.24 program. This database will be given to the statistician for obtaining and 
interpreting the results. 
. 
Limitations of the study 
 
The following limitations may arise when performing the following study: 
 
1. Poor patient adherence to the study, resulting in losses. 
2. Increased waiting times. 
3. Inability to perform the technique with the predetermined volumes. 
 
Ethical aspects 
 
Data confidentiality will be respected at all times, through anonymization of the database by 
a person external to this project, in accordance with Regulation (EU) 2016/679 of the 
European Parliament and of the Council of April 27, 2016, on the protection of natural 
persons with regard to the processing of personal data and on the free movement of such 
data (General Data Protection Regulation). Furthermore, the project will be subject to the 
standards of good clinical practice and will comply at all times with the ethical precepts 
contained in the Declaration of Helsinki, always ensuring compliance with Organic Law 
3/2018 on the protection of personal data. The ultimate goal is to respect and safeguard the 
rights to privacy, image, and information, accessing only information relevant to the study 
and separating information in a way that prevents patient identification. 
 
The results obtained will be published through normal channels of scientific dissemination, 
regardless of the results obtained. 
 
Amendments to the protocol 
 
Modifications to the initial protocol will be reported as soon as possible to the Provincial 
Research Ethics Committee of Córdoba, by submitting the new protocol highlighting the 
changes made with respect to the old one, with the aim of confirming that the established 
changes do not represent a reduction in the ethical principles of said study nor alter its 
purpose. 
 
Declaration of interests 
 
This study does not present any opportunistic interests on the part of the team members 
who accessed the data. 
 
Both the data entered into the SPSS database and the results obtained will be in the public 
domain and may be accessed by anyone upon request. These data will not contain any 
identifying information and will therefore be completely anonymous. 
 
 
 
 
 

 
13 
 
 
Additional and post-study care 
 
This type of technique is commonly used in the Physical Medicine and Rehabilitation 
Department, so if the problem is not resolved or an issue arises, treatment will be provided 
according to the established procedures within the department. 
 
Patients who show improvement will be scheduled for a one-year appointment in their 
discharge report, so they can return in the event of a relapse. Patients who have not 
improved will be referred to the Upper Extremity Trauma Unit due to the exhaustion of 
therapeutic options in our department. 
 
Dissemination Policy 
 
The results of the study will be communicated to clinical stakeholders and discussed in 
communications at scientific events and through publications in peer-reviewed scientific 
journals. The final results will also be communicated to healthcare professionals involved in 
the care of these patients through the Andalusian Health Service's internal communication 
channels. 
 
Necessary Resources 
 
The study will be conducted in the Physical Medicine and Rehabilitation Department of 
Reina University Hospital. Hospital resources, such as consultations, ultrasounds, and 
physiotherapy rooms, will be required. 
 
This study is not funded. 
 
 
 
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