Barbotage, Calcific Tendinitis, High-Energy Shock Waves, Pain, Shoulder, Tendinopathy Rotator Cuff
Conditions
Keywords
Tendinopathy Rotator Cuff, Calcific Tendinitis, High-Energy Shock Waves, Barbotage, Shoulder Pain
Brief summary
The objective of this systematic alternating 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.
Detailed description
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 systematic alternating prospective experimental longitudinal analytical 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 using a systematic alternating sequence, 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.
Interventions
PROCEDUREshockwave therapy
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.
PROCEDUREBarbotage
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.
Sponsors
Maimónides Biomedical Research Institute of Córdoba
Hospital Universitario Reina Sofia de Cordoba
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Although neither patients nor treating physicians could be blinded due to the evident technical differences between the two procedures, the statistical analysis was performed under blinded conditions. Once the follow-up period was completed, the data were transferred to a database from which all personal identifiers and any information regarding treatment allocation were removed. The two treatment groups were masked using neutral, non-identifying labels, so that the analyst had no knowledge of which intervention corresponded to each group. The analyst, who had no prior contact with the patients and was not involved in the recruitment, treatment, or follow-up phases, therefore conducted all analyses blinded to group allocation. This procedure was implemented to minimize interpretation bias and to strengthen the internal validity of the results.
Intervention model description
The study was a prospective, longitudinal, and analytical clinical trial with systematic alternating allocation. Patients were stratified into two arms according to the Bianchi-Martinoli classification (I or II/III) and, within each stratum, assigned in a 1:1 ratio to US-PICT or ESWT using a systematic alternating sequence, in which each patient received the treatment opposite to that of the previous one. Although initially described as "randomized" in the protocol, this deterministic and predictable sequence corresponds methodologically to systematic (non-random) allocation; the procedure was carried out as planned, and is described as non-randomized throughout the manuscript in accordance with the TREND statement. An initial consultation and three follow-up reviews (1, 3, and 6 months) were performed after therapy.
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 30 - 60 years. * Omoalgia lasting more than 3 months. * Radiographic and ultrasound visualization in both planes of calcification. * Sizes \> 5 millimeters (mm).
Exclusion criteria
* Patients who do not meet inclusion criteria. * Presence of another obvious cause of pain (joint degeneration, capsulitis, rotator cuff tendon tears...) * Previously received barbotage or shock waves. * Contraindication of therapies: infection, allergies to medications, cancer...
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual analgesic pain scale (VAS) | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Latineen test | 6 months | 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. |
| Patient Global Patient Improvement Impression Scale (PGI-I) | 6 months | 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". |
| Global CGI - GI Impression of Global Improvement Scale (CGI - GI) | 6 months | 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." |
| Shoulder joint balances (ROM) | 6 months | Flexion, abduction and external and internal rotation (º) measured with goniometer. |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORJavier Muñoz Paz, Medicine
Hospital Universitario Reina Sofia de Cordoba
Outcome results
None listed