NCT05915650

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Dec 2020

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

Study Start

First participant enrolled

December 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 23, 2023

Completed
Last Updated

June 23, 2023

Status Verified

June 1, 2023

Enrollment Period

1 year

First QC Date

June 1, 2023

Last Update Submit

June 22, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Visual analogue scale pain score, (VAS)

    Status of pain

    3 months after discharge

Study Arms (2)

Pain Neuroscience Education Group

EXPERIMENTAL
Behavioral: Pain Neuroscience Education

Routine Education Group

EXPERIMENTAL
Behavioral: Routine Education

Interventions

Carry out pain neuroscience education intervention for TKA patients

Pain Neuroscience Education Group

Carry out routine education intervention for TKA patients

Routine Education Group

Eligibility Criteria

Age45 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yongmei Zhang

Zunyi, Guizhou, 563000, China

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Director

Study Record Dates

First Submitted

June 1, 2023

First Posted

June 23, 2023

Study Start

December 1, 2020

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

June 23, 2023

Record last verified: 2023-06

Locations