NCT04705311

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 12, 2021

Completed
29 days until next milestone

Study Start

First participant enrolled

February 10, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

September 17, 2021

Status Verified

September 1, 2021

Enrollment Period

7 months

First QC Date

January 8, 2021

Last Update Submit

September 10, 2021

Conditions

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

Study Arms (2)

pain neuroscience education plus rotator cuff repair rehabilitation

EXPERIMENTAL
Other: Pain neuroscience educationBehavioral: Rotator cuff repair rehabilitation

rotator cuff repair rehabilitation

ACTIVE COMPARATOR
Behavioral: Rotator cuff repair rehabilitation

Interventions

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.

pain neuroscience education plus rotator cuff repair rehabilitation

Postoperative rehabilitation programs include thermal therapy, electrical therapy, manual therapy, and therapeutic exercise.

pain neuroscience education plus rotator cuff repair rehabilitationrotator cuff repair rehabilitation

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 4 weeks after receiving arthroscopic rotator cuff repair
  • If you wish to participate in research

You may not qualify if:

  • 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

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 InjuriesKinesiophobiaPain, Postoperative

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon InjuriesPhobic DisordersAnxiety DisordersMental DisordersPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 8, 2021

First Posted

January 12, 2021

Study Start

February 10, 2021

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

September 17, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share

Locations