The Effectiveness of Therapeutic Ultrasound in the Treatment of Calcific Tendinitis of the Shoulder

Summary

Rotator cuff tendinitis (RCT) has a prevalence between 2.7 and 22%, and predominantly affects middle-aged women. The pathophysiology has not been fully elucidated to date. RCT is characterized by hydroxyapatite crystal deposition in the rotator cuff tendons. Approximately half of the patients with RCT have pain with acute or chronic shoulder mobility limitation. In some patients, RCT shows a tendency for spontaneous and rapid regression.

Diagnostic ultrasound (D-US) is a non-invasive, non-ionizing, and relatively inexpensive diagnostic imaging method that is safe and reliable in assessing rotator cuff pathology. It is very sensitive in the identification of calcifications that are shown in grayscale (B-mode) as hyperechoic structures with or without acoustic shadow. Based on ultrasound findings, Chiou HJ et al. have classified calcifications into 4 types: type I are arcuate, type II are fragmented or punctiform, type III are nodular, and type IV are cystic. Spontaneous resorption may occur with type III and IV calcifications. A positive Doppler signal (PD) surrounding the calcification is highly correlated with pain intensity.

According to the European Union of Medical Specialists-Physical and Rehabilitation Medicine (UEMS-PRM) guidelines, the basis of RCT therapy is individual medical gymnastics (IMG). It includes exercises aimed to restore full shoulder mobility, and improve rotator cuff and scapular stabilizer muscles strength. Other passive procedures are elective in the choice of treatment.

Ultrasound therapy is often used in the treatment of musculoskeletal shoulder pathology due to its thermal and non-thermal effects. It is considered that tissue heating stimulates healing (vasodilation, acceleration of the metabolism, and improvement of the viscoelastic properties of the connective tissue). The frequency of ultrasound therapy is selected depending on the desired depth of action (3 MHz for surface structures up to 2.5 cm depth, and 1 MHz for deeper structures, up to 5 cm depth). Pulse mode is commonly used in acute, while continuous in chronic conditions.

To date, only a few studies have evaluated the reduction in calcification size after ultrasound therapy. Although ultrasound therapy is routinely used in the treatment of painful shoulder, reviewing the results of research published so far, we can say that current knowledge about the effectiveness of ultrasound therapy in RCT is inconsistent (only several studies with a small number of subjects, different parameters of applied ultrasound therapy in terms of penetration depth, applied energy and duration of treatment). This indicates the need for further research.

Conditions

• Rotator Cuff Tendinitis
• Shoulder Pain
• Musculoskeletal Diseases

Interventions

DEVICE

Sonopuls 490u, Enraf-Nonius, Rotterdam, Kingdom of the Netherlands

Ultrasound therapy will be applied in continuous output, 1 MHz frequency, the intensity of 1.5 W / cm2, and duration 10 min per treatment, on the front of the shoulder, on the surface of 2 ultrasound heads (10 cm2). The position of the arm will be in adduction and internal rotation in RCT of the supraspinatus, adduction and external rotation of the arm in RCT of the subscapularis, and the position of the arm over the opposite shoulder in RCT of the infraspinatus.

OTHER

Placebo

Sham ultrasound therapy will be applied using a frequency of 0 Hz, intensity 0 W / cm2, 10 min per treatment. The position of the arm will be in adduction and internal rotation in RCT of the supraspinatus, adduction and external rotation of the arm in RCT of the subscapularis, and the position of the arm over the opposite shoulder in RCT of the infraspinatus.

Sponsors & Collaborators

• Clinical Hospital Centre Zagreb

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-30

Primary Completion

2022-04-30

Completion

2023-01-31

Countries

• Croatia

Study Locations