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

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: Pain
• Intervention / Treatment: Behavioral: Pain Neuroscience Education; Behavioral: Routine Education

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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)	Status of pain	3 months after discharge

Collaborators and Investigators

• Sponsor: Zunyi Medical College

Study record dates

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: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• 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