The objective of this block randomized prospective experimental longitudinal analytical clinical trial is to compare the mean differences in Visual analgesic scale (VAS) at 1 month, 3 months and 6 months depending on the treatment received, ultrasound-guided barbotage (US-PICT) or shock waves (ESWT), in patients with calcifying tendinopathies according to the lesion based on the Bianchi Martinolli classification, as well as to know if there are variations in functionality with the Latinen test, joint balance, patient global improvement impression scale (PGI-I), global improvement impression scale (CGI - GI). For this purpose, patients between 30 and 60 years old, with chronic shoulder pain for more than 3 months due only to calcifying tendinopathies who have not received these previous treatments will be selected. The main question to be answered is: Do patients with calcifying tendinopathies of the shoulder, in its different degrees, who have received as treatment barbottage, obtain the same VAS differences at 1 month, 3 month and 6 month as patients who received as treatment shock waves in the population? Patients will be sorted into two arms according to the Bianchi Martinoli classification (I or II/ III) and subsequently included in groups according to the treatment received. The decision to treat with one or the other therapy will be made randomly 1:1, depending on the treatment assigned to the previous patient. An initial consultation and 3 revisions (1 month, 3 months and 6 months) will be performed after the end of therapy. The following variables will be collected VAS, Lattinen test, joint balances (ROM) (flexion, abduction and external and internal rotation), PGI-I, CGI - GI.
Shoulder pain is a very common health issue among adults, being 8% due to calcifying tendinopathies of the shoulder (CT). The evolutionary process of this lesion can be classified according to Bianchi Martinoli as I: hard, II: semi-soft and III: soft due to their ultrasound appearance. In 50% of cases, with first-line treatments such as kinesitherapy and taking anti-inflammatories, they resolve spontaneously. However, in the remaining 50% they become chronic, requiring other lines of treatment such as shock waves (ESWT) or ultrasound-guided barbotage (US-PICT). Starting hypothesis: Patients with CT, in its different degrees, who have received barbottage as treatment, obtain the same VAS differences at 1 month, 3 months and 6 months as patients who received ESWT as treatment in the population. Main objective: * The main objective is to compare the mean differences in VAS at 1 month, 3 months and 6 months according to the treatment received, barbotage or ESWT in patients with CT according to the evolutionary stage of the lesion based on the Bianchi Martinolli classification. Secondary objectives: * To know if there are variations in functionality with the Latinen test, joint balance (ROM), PGI and CGI. * To protocolize an attitude towards this type of pathology. * To favor the use of hospital resources. We propose to conduct a block randomized prospective experimental longitudinal analytical block randomized clinical trial. For this purpose, patients aged between 30 - 60 years, with chronic shoulder pain for more than 3 months due only to calcifying tendinopathies will be selected. The protocol carried out was as follows: 1. st Phase : in this first phase, patients will be collected according to the criteria set out above for a period of 12 months. During this time, the patients will be explained the two possible treatments to be received and after signing the appropriate informed consent, they will be divided into groups according to treatment (ESWT vs US-PICT) stratifying according to the Bianchi Martinolli classification: (I or II/IIII). The decision for each treatment will be made randomly, dividing the patients in a 1:1 ratio according to whether they attend the initial consultation and the previous patient has received one or the other treatment. 2. nd Phase: Subsequently, 3 revisions will be performed. One at 1 month, 3 months and another one at 6 months after the end of the therapy. 3. rd Phase: The information collected will be synthesized and entered into the SPSS V.21 program to obtain results.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
ESWT, these will be given using a 15 mm transmitter in mode continuous with pressure at 3 bar, frequency 12Hz and 3000 impacts. The number of sessions will be between 4 - 8 depending on the patient's clinic with a break between sessions of 5 to 10 days.
US-PICT will be carried out with 1 session in which the following actions will be carried out: * First, a suprascapular nerve block will be performed with a corticosteroid and anesthetic (3 ml of bupivacaine) in an ultrasound-guided manner. * The calcification will then be infiltrated with 5 ml local lidocaine and preloaded physiological saline solution in an ultrasound-guided manner. * Finally, repeated suctions will be performed with physiological saline solution to extract calcium in an ultrasound-guided way.
Hospital Universitario Reina Sofia
Córdoba, Córdoba, Spain
Visual analgesic pain scale (VAS)
The VAS will be measured in the initial consultation and at 1, 3 and 6 months after the intervention and a new variable "VAS Difference" (DifVAS) will be created for each corresponding VAS level in the review consultations.
Time frame: 6 months
Latineen test
The Latineen test is a widely used tool for pain evaluation. Initial, at 1, 3 and 6 months of each variable. It contains five subscales that score from 0 to 4: 1\. Pain intensity. 2. Frequency of pain. 3. Consumption of painkillers. 4. Degree of disability. 5. Hours of sleep.
Time frame: 6 months
Patient Global Patient Improvement Impression Scale (PGI-I)
The PGI-I consists of a single question that asks the patient to classify the relief obtained with the treatment according to a 7-point Likert scale: "much better"; "much better"; "a little better"; "no change"; "a little worse"; "much worse"; "much worse".
Time frame: 6 months
Global CGI - GI Impression of Global Improvement Scale (CGI - GI)
The CGI-Improvement (CGI-I) , the physician compares the patient's initial clinical condition with the current condition: "Compared to the patient's condition at the time of admission to the project \[prior to the start of medication\], this patient's condition is: 1=much better since the start of treatment; 2=much improved; 3=minimally improved; 4=no change since baseline (the start of treatment); 5=minimally worse; 6=much worse; 7=much worse since the start of treatment."
Time frame: 6 months
Shoulder joint balances (ROM)
Flexion, abduction and external and internal rotation (º) measured with goniometer.
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.