Calcific Tendinitis Clinical Trial
Official title:
The Therapeutic Effect of the Extracorporeal Shock Wave Therapy on Shoulder Calcific Tendinitis
Calcific tendinopathy of the shoulder is often self-limited with a relatively benign clinical
course. Therefore, first-line therapy should be conservative and focused on symptom relief.
However, studies show patients with Large volume deposits (e.g. ≥1500 mm3) and Subacromial
extension of the deposits respond poorly to initial treatment such as analgesic medication,
glucocorticoid injection, and physical therapy. For those refractory cases, extracorporeal
shock wave therapy is introduced and shows resolution of symptoms and improvement in shoulder
function in approximately 70 percent of patients.
Extracorporeal shock wave therapy uses acoustic waves to fragment calcific deposits.
Variables of the settings include dose (low or high energy), duration (impulses), and the
interval of administration. However, an optimum value for the total cumulative dose of energy
that should be administered has not yet been defined. Our study thus aim to find out the
dosage effect of ESWT on the calcific debris sizes, pain, daily living functions, and
shoulder range of motions in the calcific tendinitis patients.
Calcific tendinopathy of the shoulder is caused by unknown etiology characterized by the
formation of calcific deposits in on or several tendons of the rotator cuff muscles:
supraspinatus, infraspinatus, teres minor, and subscapularis muscles. The calcific deposits
is often composed of poorly crystallized hydroxyapatite, an inorganic component of bone
tissue, but the pathogenesis of rotator cuff disorders is still incomplete.
The clinical presentations of calcific tendinopathy typically involve shoulder pain similar
to that experienced by patients with rotator cuff tendinopathy or shoulder impingement
syndrome. Pain is the cardinal symptom and is localized on the top or lateral aspect of the
shoulder or both, often with radiation towards the insertion of the deltoid. The onset of
pain is gradual and unassociated with trauma. Daily activities involving overhead motions,
such as putting on a shirt or brushing hair, can be painful, thus decreasing quality of life
immensely.
Calcific tendinopathy of the shoulder is often self-limited with a relatively benign clinical
course. Therefore, first-line therapy should be conservative and focused on symptom relief.
However, some remain ineffective to the initial treatment. For those refractory cases,
extracorporeal shock wave therapy (ESWT) is introduced and shows resolution of symptoms and
improvement in shoulder function in approximately 70 percent of patients.
ESWT uses acoustic waves to fragment calcific deposits. Variables of the settings include
dose (low or high energy), duration (impulses), and the interval of administration. However,
an optimum value for the total cumulative dose of energy that should be administered has not
yet been defined. Our study thus aim to find out the dosage effect of ESWT on the calcific
debris sizes, pain, daily living functions, and shoulder range of motions in the calcific
tendinitis patients.
The study will be a prospective assessor-blinded randomized controlled trial. Patients who
have calcific tendinitis diagnosed by shoulder sonography or X-ray, fail to improve despite
appropriate conservative treatment for three months will be recruited. The subjects will be
randomized distributed in 3 groups: High Energy, Low Energy, and Sham groups, and each group
has 30 patients.
Upon completion of the study, the result will show whether different dosage of ESWT has
different therapeutic effects on shoulder calcific tendinitis. In the future, the study may
be the foundation of the ESWT treatment guideline for rotator calcific tendinitis.
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