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The Effect of Pain Neuroscience Education on Patients With Arthroscopic Rotator Cuff Repair

Primary Purpose

Rotator Cuff Injuries, Kinesiophobia, Pain, Postoperative

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Pain neuroscience education

Rotator cuff repair rehabilitation

About this trial

This is an interventional treatment trial for Rotator Cuff Injuries

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adults over 18 years old
In case of 4 weeks after receiving arthroscopic rotator cuff repair
If you wish to participate in research

Exclusion Criteria:

65 years old or older
Those who are limited in conducting education remotely
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
If you cannot understand the guidelines for evaluation or intervention
Mental health and cognitive problems

Sites / Locations

The Better Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

pain neuroscience education plus rotator cuff repair rehabilitation

rotator cuff repair rehabilitation

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

NCT04705311

First Posted

January 8, 2021

Last Updated

September 10, 2021

Sponsor

Sahmyook University

1. Study Identification

Unique Protocol Identification Number

NCT04705311

Brief Title

The Effect of Pain Neuroscience Education on Patients With Arthroscopic Rotator Cuff Repair

Official Title

The Effect of Pain Neuroscience Education on Patients With Arthroscopic Rotator Cuff Repair

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

February 10, 2021 (Actual)

Primary Completion Date

August 31, 2021 (Actual)

Study Completion Date

August 31, 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

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

During the rehabilitation process after rotator cuff repair surgery, patients suffer from increased pain and discomfort due to dysfunction. Pain neuroscience education, a more modern educational method, has been reported to be effective in controlling pain by reducing the fear of movement based on an understanding of neurophysiology.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rotator Cuff Injuries, Kinesiophobia, Pain, Postoperative

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

pain neuroscience education plus rotator cuff repair rehabilitation

Arm Type

Experimental

Arm Title

rotator cuff repair rehabilitation

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

Pain neuroscience education

Intervention Description

Neurophysiological education of pain allows patients to explore a wider contribution to pain through the knowledge that pain is often an unreliable indicator of the extent or extent of tissue damage. This aims at reconceptualization from biomedical or structural models to actual biological psychosocial pain models.

Intervention Type

Behavioral

Intervention Name(s)

Rotator cuff repair rehabilitation

Intervention Description

Postoperative rehabilitation programs 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 in pain intensity from baseline to weeks 2, 4, and 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adults over 18 years old In case of 4 weeks after receiving arthroscopic rotator cuff repair If you wish to participate in research Exclusion Criteria: 65 years old or older Those who are limited in conducting education remotely 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 If you cannot understand the guidelines for evaluation or intervention Mental health and cognitive problems

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

The Effect of Pain Neuroscience Education on Patients With Arthroscopic Rotator Cuff Repair

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