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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Pain Neuroscience Education

Routine Education

About this trial

This is an interventional supportive care trial for Pain

Eligibility Criteria

45 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients diagnosed as KOA according to the criteria and undergoing unilateral total knee arthroplasty for the first time; The subjects included in this study were men or women aged 45-74 years; Clear self-cognition, can browse the text by themselves or can answer questions correctly; Those who voluntarily participated in the study and signed an informed consent form after understanding the relevant information of the study; Without serious physical diseases such as heart, liver or kidney; No history of mental illness or drug dependence. Exclusion Criteria: Combined with severe trauma in other parts; Accompanied by serious damage to other organs, such as heart and cerebrovascular diseases, lung and kidney diseases; Patients with knee tumor and severe knee deformity who could not complete the rehabilitation; With neurological diseases that limit physical activity; Participating in other investigators during the same period.

Sites / Locations

Yongmei Zhang

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Pain Neuroscience Education Group

Routine Education Group

Arm Description

Outcomes

Primary Outcome Measures

Visual analogue scale pain score, (VAS)

Status of pain

Secondary Outcome Measures

Full Information

NCT ID

NCT05915650

First Posted

June 1, 2023

Last Updated

June 22, 2023

Sponsor

Zunyi Medical College

1. Study Identification

Unique Protocol Identification Number

NCT05915650

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

December 1, 2020 (Actual)

Primary Completion Date

December 1, 2021 (Actual)

Study Completion Date

December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zunyi Medical College

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

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

Pain

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pain Neuroscience Education Group

Arm Type

Experimental

Arm Title

Routine Education Group

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

Pain Neuroscience Education

Intervention Description

Carry out pain neuroscience education intervention for TKA patients

Intervention Type

Behavioral

Intervention Name(s)

Routine Education

Intervention Description

Carry out routine education intervention for TKA patients

Primary Outcome Measure Information:

Title

Visual analogue scale pain score, (VAS)

Description

Status of pain

Time Frame

3 months after discharge

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

74 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Patients diagnosed as KOA according to the criteria and undergoing unilateral total knee arthroplasty for the first time; The subjects included in this study were men or women aged 45-74 years; Clear self-cognition, can browse the text by themselves or can answer questions correctly; Those who voluntarily participated in the study and signed an informed consent form after understanding the relevant information of the study; Without serious physical diseases such as heart, liver or kidney; No history of mental illness or drug dependence. Exclusion Criteria: Combined with severe trauma in other parts; Accompanied by serious damage to other organs, such as heart and cerebrovascular diseases, lung and kidney diseases; Patients with knee tumor and severe knee deformity who could not complete the rehabilitation; With neurological diseases that limit physical activity; Participating in other investigators during the same period.

Facility Information:

Facility Name

Yongmei Zhang

City

Zunyi

State/Province

Guizhou

ZIP/Postal Code

563000

Country

China

Pain

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial