Effect of Extracorporeal Shock Wave Therapy After Arthroscopic Rotator Cuff Repair

July 7, 2021 updated by: Hyun-Joong Kim, Sahmyook University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radial extracorporeal shockwave therapy
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
. Pain intensity
Time Frame: Change from baseline pain intensity at 2 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahmyook University

Investigators

  • Principal Investigator: Hyun-Joong Kim, MSc, Principal Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2021

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

July 8, 2021

Study Registration Dates

First Submitted

April 13, 2021

First Submitted That Met QC Criteria

April 13, 2021

First Posted (Actual)

April 19, 2021

Study Record Updates

Last Update Posted (Actual)

July 13, 2021

Last Update Submitted That Met QC Criteria

July 7, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2-1040781-A-N-012021035HR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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