Physical Therapy Interventions Following Arthroscopic Rotator Cuff Repair

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Rotator Cuff Injuries; Kinesiophobia
• Intervention / Treatment: Behavioral: physical therapy intervention

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gwangju, Korea, Republic of, 61085
    • The Better Hospital

Participation Criteria

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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: physical therapy intervention	Behavioral: physical therapy intervention; physical therapy interventions include thermal therapy, electrical therapy, manual therapy, and therapeutic exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 12 weeks

Collaborators and Investigators

• Sponsor: Sahmyook University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 17, 2021
• Primary Completion (ACTUAL): September 3, 2021
• Study Completion (ACTUAL): September 3, 2021

Study Registration Dates

• First Submitted: January 13, 2021
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (ACTUAL): January 15, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 17, 2021
• Last Update Submitted That Met QC Criteria: September 10, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Pain, Postoperative; Rotator Cuff Injuries
• Other Study ID Numbers: 2-1040781-A-N-012021012HR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No