Back to resultsPhysical Therapy Interventions Following Arthroscopic Rotator Cuff Repair
Primary Purpose
Rotator Cuff Injuries, Pain, Postoperative, Kinesiophobia
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
physical therapy intervention
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 2 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
physical therapy intervention
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
NCT ID
NCT04711616
First Posted
January 13, 2021
Last Updated
September 10, 2021
Sponsor
Sahmyook University
1. Study Identification
Unique Protocol Identification Number
NCT04711616
Brief Title
Physical Therapy Interventions Following Arthroscopic Rotator Cuff Repair
Official Title
Physical Therapy Interventions Following Arthroscopic Rotator Cuff Repair: A Prospective Single Group Interventional Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
March 17, 2021 (Actual)
Primary Completion Date
September 3, 2021 (Actual)
Study Completion Date
September 3, 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
In the post-arthroscopic rotator cuff repair (ARCR) management, physical therapy intervention is an important factor in bringing about a clinically positive prognosis. However, no conclusive therapeutic evidence has been found for various physical therapy interventions. In this study, the investigators would like to investigate the effects of physical therapy interventions on ARCR patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Injuries, Pain, Postoperative, Kinesiophobia
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
physical therapy intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
physical therapy intervention
Intervention Description
physical therapy interventions include thermal therapy, electrical therapy, manual therapy, and therapeutic 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 12 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 2 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
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
Yes
Learn more about this trial
Physical Therapy Interventions Following Arthroscopic Rotator Cuff Repair
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