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.
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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | ChiMei Medical Center | Tainan |
Lead Sponsor | Collaborator |
---|---|
Chimei Medical Center |
Taiwan,
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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