Clinical trial NCT06528756: Calciying Tendinopathy of the Rotator Cuff: Barbotage Vs Shock Waves
Official title: Calciying Tendinopathy of the Rotator Cuff: Barbotage Vs Shock Waves
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tendinopathy Rotator Cuff
Calcific Tendinitis
High-Energy Shock Waves
Barbotage
Pain, Shoulder
Keywords: Tendinopathy Rotator Cuff
Calcific Tendinitis
High-Energy Shock Waves
Barbotage
Shoulder Pain
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Reina Sofia de Cordoba
First posted: 2024-07-30
Enrollment: 56
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective block-randomized experimental longitudinal analytical clinical trial

Patients will be stratified into two arms according to the Bianchi Martinoli classification (I or II/III) and will subsequently be included in groups based on the treatment received, US-PICT or ESWT . The decision to treat with one or another therapy will be made randomly 1:1, based on the treatment assigned to the previous patient. An initial consultation and 3 reviews (1 month, 3 months and 6 months) will be carried out after completing the therapy.
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Eligibility criteria: 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...

Primary outcomes:
measure: Visual analgesic pain scale (VAS)
timeFrame: 6 months
Secondary outcomes:
measure: Latineen test
timeFrame: 6 months
measure: Patient Global Patient Improvement Impression Scale (PGI-I)
timeFrame: 6 months
measure: Global CGI - GI Impression of Global Improvement Scale (CGI - GI)
timeFrame: 6 months
measure: Shoulder joint balances (ROM)
timeFrame: 6 months
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia
Study officials:
affiliation: Hospital Universitario Reina Sofia de Cordoba
name: Javier Muñoz Paz, Medicine
role: PRINCIPAL_INVESTIGATOR
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