Application of PNE in Postoperative Pain Management of Patients With Primary Total Knee Arthroplasty

June 22, 2023 updated by: Yongmei Zhang, Zunyi Medical College
This study intends to carry out pain neuroscience education intervention for TKA patients to clarify the effect of this method on the degree of postoperative pain, the incidence of pain catastrophizing, kinesiophobia, and knee joint function rehabilitation in TKA patients, so as to provide a basis for clinical nursing of such patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guizhou
      • Zunyi, Guizhou, China, 563000
        • Yongmei Zhang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients diagnosed as KOA according to the criteria and undergoing unilateral total knee arthroplasty for the first time;
  2. The subjects included in this study were men or women aged 45-74 years;
  3. Clear self-cognition, can browse the text by themselves or can answer questions correctly;
  4. Those who voluntarily participated in the study and signed an informed consent form after understanding the relevant information of the study;
  5. Without serious physical diseases such as heart, liver or kidney;
  6. No history of mental illness or drug dependence.

Exclusion Criteria:

  1. Combined with severe trauma in other parts;
  2. Accompanied by serious damage to other organs, such as heart and cerebrovascular diseases, lung and kidney diseases;
  3. Patients with knee tumor and severe knee deformity who could not complete the rehabilitation;
  4. With neurological diseases that limit physical activity;
  5. Participating in other investigators during the same period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pain Neuroscience Education Group
Behavioral: Pain Neuroscience Education
Carry out pain neuroscience education intervention for TKA patients
Experimental: Routine Education Group
Behavioral: Routine Education
Carry out routine education intervention for TKA patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue scale pain score, (VAS)
Time Frame: 3 months after discharge
Status of pain
3 months after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zunyi Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

June 1, 2023

First Submitted That Met QC Criteria

June 22, 2023

First Posted (Actual)

June 23, 2023

Study Record Updates

Last Update Posted (Actual)

June 23, 2023

Last Update Submitted That Met QC Criteria

June 22, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KLLY-2020-147

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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