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

• Sponsor: Zunyi Medical College (Other)
• Overall Status: Completed
• CT.gov ID: NCT05915650
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Actual Duration (Months): 12
• Patients Per Site Per Month: 5.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Behavioral: Pain Neuroscience Education; Behavioral: Routine Education	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Application of PNE in Postoperative Pain Management of Patients With Primary Total Knee Arthroplasty
• Actual Study Start Date: Dec 1, 2020
• Actual Primary Completion Date: Dec 1, 2021
• Actual Study Completion Date: Dec 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Visual analogue scale pain score, (VAS) [3 months after discharge]

   Status of pain

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 74 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yongmei Zhang	Zunyi	Guizhou	China	563000

Sponsors and Collaborators

• Zunyi Medical College

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yongmei Zhang, Study Director, Zunyi Medical College
• ClinicalTrials.gov Identifier: NCT05915650
• Other Study ID Numbers: KLLY-2020-147
• First Posted: Jun 23, 2023
• Last Update Posted: Jun 23, 2023
• Last Verified: Jun 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pain, Postoperative

Study Results

No Results Posted as of Jun 23, 2023