NCT04711616

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

March 17, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2021

Completed
Last Updated

September 17, 2021

Status Verified

September 1, 2021

Enrollment Period

6 months

First QC Date

January 13, 2021

Last Update Submit

September 10, 2021

Conditions

Rotator Cuff InjuriesPain, PostoperativeKinesiophobia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

physical therapy intervention

EXPERIMENTAL
Behavioral: physical therapy intervention

Interventions

physical therapy interventionBEHAVIORAL

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

physical therapy intervention

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Better Hospital

Gwangju, 61085, South Korea

Location

MeSH Terms

Conditions

Rotator Cuff InjuriesPain, PostoperativeKinesiophobia

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon InjuriesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPhobic DisordersAnxiety DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 13, 2021

First Posted

January 15, 2021

Study Start

March 17, 2021

Primary Completion

September 3, 2021

Study Completion

September 3, 2021

Last Updated

September 17, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share

Locations

KR(1)