Back to resultsEffect of Extracorporeal Shock Wave Therapy After Arthroscopic Rotator Cuff Repair
Primary Purpose
Rotator Cuff Injuries, Pain, Postoperative, Tissue Adhesion
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Radial extracorporeal shockwave therapy
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Injuries
Eligibility Criteria
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
Sites / Locations
- The Better Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Radial extracorporeal shockwave therapy
Arm Description
Outcomes
Primary Outcome Measures
. 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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04848103
Brief Title
Effect of Extracorporeal Shock Wave Therapy After Arthroscopic Rotator Cuff Repair
Official Title
Effect of Extracorporeal Shock Wave Therapy After Arthroscopic Rotator Cuff Repair
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 10, 2021 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
July 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahmyook University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Injuries, Pain, Postoperative, Tissue Adhesion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Radial extracorporeal shockwave therapy
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Radial extracorporeal shockwave therapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
. Pain intensity
Description
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.
Time Frame
Change from baseline pain intensity at 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyun-Joong Kim, MSc
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Better Hospital
City
Gwangju
ZIP/Postal Code
61085
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36107497
Citation
Kim HJ, Choi W, Jung J, Park S, Joo Y, Lee S, Lee S. Efficacy of radial extracorporeal shockwave therapy in rehabilitation following arthroscopic rotator cuff repair: A STROBE compliant study. Medicine (Baltimore). 2022 Sep 2;101(35):e30053. doi: 10.1097/MD.0000000000030053.
Results Reference
derived
Learn more about this trial
Effect of Extracorporeal Shock Wave Therapy After Arthroscopic Rotator Cuff Repair
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