Calciying Tendinopathy of the Rotator Cuff: Barbotage Vs Shock Waves

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.

Conditions

• Tendinopathy Rotator Cuff
• Calcific Tendinitis
• High-Energy Shock Waves
• Barbotage
• Pain, Shoulder

Interventions

PROCEDURE

shockwave 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.

PROCEDURE

Barbotage

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 & Collaborators

• Hospital Universitario Reina Sofia de Cordoba

  collaborator OTHER_GOV

• Maimónides Biomedical Research Institute of Córdoba

  lead OTHER

Principal Investigators

• Javier Muñoz Paz, Medicine · Hospital Universitario Reina Sofia de Cordoba

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-08

Primary Completion

2025-11-23

Completion

2025-11-23

Countries

• Spain

Study Locations