The Effect of Pain Neuroscience Education on Patients With Arthroscopic Rotator Cuff Repair
1 other identifier
interventional
34
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2021
Shorter than P25 for not_applicable
1 active site
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 8, 2021
CompletedFirst Posted
Study publicly available on registry
January 12, 2021
CompletedStudy Start
First participant enrolled
February 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2021
CompletedSeptember 17, 2021
September 1, 2021
7 months
January 8, 2021
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
EXPERIMENTALrotator cuff repair rehabilitation
ACTIVE COMPARATORInterventions
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.
Postoperative rehabilitation programs include thermal therapy, electrical therapy, manual therapy, and therapeutic exercise.
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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