Physical Therapy Interventions Following Arthroscopic Rotator Cuff Repair

Sponsor

Sahmyook University (Other)

Overall Status

Completed

CT.gov ID

NCT04711616

Collaborator

(none)

Enrollment

Location

Arm

5.6

Actual Duration (Months)

5.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Rotator Cuff Injuries Pain, Postoperative Kinesiophobia	Behavioral: physical therapy intervention	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Physical Therapy Interventions Following Arthroscopic Rotator Cuff Repair: A Prospective Single Group Interventional Study

Actual Study Start Date :

Mar 17, 2021

Actual Primary Completion Date :

Sep 3, 2021

Actual Study Completion Date :

Sep 3, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: physical therapy intervention	Behavioral: physical therapy intervention physical therapy interventions include thermal therapy, electrical therapy, manual therapy, and therapeutic exercise.

Arm

Intervention/Treatment

Experimental: physical therapy intervention

Behavioral: physical therapy intervention

physical therapy interventions include thermal therapy, electrical therapy, manual therapy, and therapeutic exercise.

Outcome Measures

Primary Outcome Measures

Pain intensity [Change from baseline pain intensity at 12 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Better Hospital	Gwangju		Korea, Republic of	61085

Sponsors and Collaborators

Sahmyook University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hyun-Joong Kim, Principal Investigator, Sahmyook University

ClinicalTrials.gov Identifier:

NCT04711616

Other Study ID Numbers:

2-1040781-A-N-012021012HR

First Posted:

Jan 15, 2021

Last Update Posted:

Sep 17, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Rotator Cuff Injuries

Study Results

No Results Posted as of Sep 17, 2021