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The Therapeutic Effect of the Extracorporeal Shock Wave Therapy on Shoulder Calcific Tendinitis

Primary Purpose

Calcific Tendinitis

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
extracorporeal shock wave
Sponsored by
Chimei Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Calcific Tendinitis

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ChiMei Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

High Energy

Low Energy

Sham

Arm Description

Extracorporeal shock wave therapy with 0.3 millijoule/mm2 of 3000 shots will be administered via sonographic guidance of the target calcific tendinitis.

Extracorporeal shock wave therapy with 0.05 millijoule/mm2 of 3000 shots will be administered via sonographic guidance of the target calcific tendinitis.

Extracorporeal shock wave therapy with 0 millijoule/mm2 of 3000 shots will be administered via sonographic guidance of the target calcific tendinitis.

Outcomes

Primary Outcome Measures

changes from baseline in the calcium deposits
Calcium deposits will be measured via X-ray or sonography.

Secondary Outcome Measures

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)
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).

Full Information

First Posted
December 17, 2018
Last Updated
December 20, 2018
Sponsor
Chimei Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03779919
Brief Title
The Therapeutic Effect of the Extracorporeal Shock Wave Therapy on Shoulder Calcific Tendinitis
Official Title
The Therapeutic Effect of the Extracorporeal Shock Wave Therapy on Shoulder Calcific Tendinitis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 18, 2018 (Actual)
Primary Completion Date
May 31, 2020 (Anticipated)
Study Completion Date
May 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chimei Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calcific Tendinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High Energy
Arm Type
Experimental
Arm Description
Extracorporeal shock wave therapy with 0.3 millijoule/mm2 of 3000 shots will be administered via sonographic guidance of the target calcific tendinitis.
Arm Title
Low Energy
Arm Type
Experimental
Arm Description
Extracorporeal shock wave therapy with 0.05 millijoule/mm2 of 3000 shots will be administered via sonographic guidance of the target calcific tendinitis.
Arm Title
Sham
Arm Type
Placebo Comparator
Arm Description
Extracorporeal shock wave therapy with 0 millijoule/mm2 of 3000 shots will be administered via sonographic guidance of the target calcific tendinitis.
Intervention Type
Device
Intervention Name(s)
extracorporeal shock wave
Intervention Description
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.
Primary Outcome Measure Information:
Title
changes from baseline in the calcium deposits
Description
Calcium deposits will be measured via X-ray or sonography.
Time Frame
one month and 3 months after shock wave
Secondary Outcome Measure Information:
Title
functional score
Description
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)
Time Frame
one month and 3 months after shock wave
Title
pain score
Description
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).
Time Frame
one month and 3 months after shock wave

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi-Ming Lo, MD
Phone
+886-6-2612611
Ext
55000
Email
loyiming@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hsin-Han Cheng, MD
Phone
+886926722119
Email
a11010147@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsin-Han Cheng, MD
Organizational Affiliation
ChiMei Medical Center, Taiwan, R.O.C.
Official's Role
Principal Investigator
Facility Information:
Facility Name
ChiMei Medical Center
City
Tainan
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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The Therapeutic Effect of the Extracorporeal Shock Wave Therapy on Shoulder Calcific Tendinitis

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