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Completed

NCT Number: NCT06528756

Calciying Tendinopathy of the Rotator Cuff: Barbotage Vs Shock Waves

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.

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Key information

Conditions

Tendinopathy Rotator Cuff Arthralgia Barbotage Calcific Tendinitis High-Energy Shock Waves Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pain, Shoulder Pathological Conditions, Signs and Symptoms Shoulder Pain Signs and Symptoms

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

About this study

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:

  • 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.
  • 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.
  • rd Phase: The information collected will be synthesized and entered into the SPSS V.21 program to obtain results.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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...

Treatment and study plan

SHOCKWAVE THERAPY

Procedure

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.

Other names: ESWT

Barbotage

Procedure

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.

Other names: US-PICT

Primary outcomes

  1. Visual analgesic pain scale (VAS)

    Time frame: 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 outcomes

  1. Latineen test

    Time frame: 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:

    • Pain intensity. 2. Frequency of pain. 3. Consumption of painkillers. 4. Degree of disability. 5. Hours of sleep.

  2. Patient Global Patient Improvement Impression Scale (PGI-I)

    Time frame: 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".

  3. Global CGI - GI Impression of Global Improvement Scale (CGI - GI)

    Time frame: 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."

  4. Shoulder joint balances (ROM)

    Time frame: 6 months

    Flexion, abduction and external and internal rotation (º) measured with goniometer.

Sponsors and collaborators

Lead sponsor

Maimónides Biomedical Research Institute of Córdoba

Other

Collaborators

  • Hospital Universitario Reina Sofia de Cordoba

Registry information

Acronym: BOTCH

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 30, 2024
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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