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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03779919
Other study ID # CMMC10709-004
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 18, 2018
Est. completion date May 31, 2020

Study information

Verified date December 2018
Source Chimei Medical Center
Contact Yi-Ming Lo, MD
Phone +886-6-2612611
Email loyiming@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date May 31, 2020
Est. primary completion date May 31, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria:

.age 20-70 with calcific tendinitis via sonography or x-ray in rotator cuff

Exclusion Criteria:

.no shoulder fracture, no abnormality, gout or autoimmune disease

Study Design


Related Conditions & MeSH terms


Intervention

Device:
extracorporeal shock wave
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.

Locations

Country Name City State
Taiwan ChiMei Medical Center Tainan

Sponsors (1)

Lead Sponsor Collaborator
Chimei Medical Center

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary changes from baseline in the calcium deposits Calcium deposits will be measured via X-ray or sonography. one month and 3 months after shock wave
Secondary functional score The 100-point Constant score will be used to provide an overall clinical assessment of the shoulder with respect to the degree of pain, the patient's ability to perform normal tasks of daily living (maximal score, 35), and the active range of motion and power of the shoulder, or torque (maximal score, 65) one month and 3 months after shock wave
Secondary pain score The severity of pain at night and during the day, both on movement and at rest, is assessed by means of a visual-analogue scale that ranges from 0 (no pain) to 10 (severe pain). one month and 3 months after shock wave
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