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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04848103
Other study ID # 2-1040781-A-N-012021035HR
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 10, 2021
Est. completion date July 8, 2021

Study information

Verified date July 2021
Source Sahmyook University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Although radial extracorporeal shock wave therapy (rESWT) has proven to be an effective treatment, the effectiveness of the treatment has so far been controversial. There are no studies using rESWT in rehabilitation after arthroscopic rotator cuff repair (ARCR). Therefore, in this study, there is evidence that rESWT promotes pain control and healing recovery, and through previous studies, we would like to investigate whether treatment with rESWT during the intensive rehabilitation period of patients after ARCR is more effective in controlling pain.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date July 8, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 19 Years to 65 Years
Eligibility Inclusion Criteria: - Adults over 18 years old - In case of 6 weeks after receiving arthroscopic rotator cuff repair - When the participants wishes to enroll in the study Exclusion Criteria: - 65 years old or older - If the tear area is large and augmentation is performed - If there is a previous surgical history at the surgical site - Osteoarthritis in the shoulder joint

Study Design


Intervention

Behavioral:
Radial extracorporeal shockwave therapy
Radial extracorporeal shockwave therapy group include Therapeutic modality(Transcutaneous electrical nerve stimulation [TENS], Microwave thermotherapy, and Superficial heat therapy), Range of motion exercise(Continuous passive motion and Active range of motion exercise).

Locations

Country Name City State
Korea, Republic of The Better Hospital Gwangju

Sponsors (1)

Lead Sponsor Collaborator
Sahmyook University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary . Pain intensity A numeric pain rating scale (NPRS) consisting of 11 points in total from 0 points (no pain) to 10 points (the most severe pain imaginable) is used. The lower the score, the less the pain. Change from baseline pain intensity at 2 weeks
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