Calciying Tendinopathy of the Rotator Cuff: Barbotage Vs Shock Waves
NCT Number: NCT06528756
Acronym: BOTCH
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tendinopathy Rotator Cuff|Calcific Tendinitis|High-Energy Shock Waves|Barbotage|Pain, Shoulder
Interventions: PROCEDURE: shockwave therapy|PROCEDURE: Barbotage
Sponsor: Maimónides Biomedical Research Institute of Córdoba
Collaborators: Hospital Universitario Reina Sofia de Cordoba
Sex: ALL
Age: ADULT
Enrollment: 56
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-01-08
Completion Date: 2025-04
Locations: Hospital Universitario Reina Sofia, Córdoba, 14004, Spain

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.

Primary Outcome Measures: 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., 6 months
Secondary Outcome Measures: 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., 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"., 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.", 6 months|Shoulder joint balances (ROM), Flexion, abduction and external and internal rotation (º) measured with goniometer., 6 months