Pain Neuroscience Education in Total Knee Arthroplasty

Total Knee Replacement Clinical Trial

Official title:

A Randomized Clinical Trial of Preoperative Pain Neuroscience Education for Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03231566
• Other study ID #: 710848-3
• Status: Completed
• Phase: N/A
• First received: July 13, 2017
• Last updated: July 24, 2017
• Start date: February 28, 2015
• Est. completion date: March 20, 2017

Study information

• Verified date: July 2017
• Source: University of Nevada, Las Vegas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine if education about pain given prior to Knee Arthroplasty will result in better outcomes following surgery

Description:

To determine if a preoperative pain neuroscience education (PNE) program would result in superior outcomes compared to usual preoperative education for total knee arthroplasty (TKA). Patients will receive traditional hospital preoperative TKA program (usual care group) or receive the same program plus an additional 30-minute PNE program (experimental group). Pre and post measurements at 1, 3 and 6 months for pain, function, fear of movement and pain catastrophization. We will also compare opioid usage, healthcare expenses and patient satisfaction between groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 20, 2017
• Est. primary completion date: March 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• be scheduled to have a TKA and their standard preoperative TKA education program, indicate their willingness to participate in the study, ability to read and understand English, as the study included the use of an educational booklet, and be able and willing to complete outcome data for 6 months after TKA

Exclusion Criteria:

• Because all potential participants for this study had been screened and cleared for their orthopedic surgery, the only exclusion criterion was an unwillingness to participate in the study and having had a previous TKA or scheduled for a bilateral TKA.

Related Conditions & MeSH terms

• Total Knee Replacement

Intervention

Behavioral:
• Pain Neuroscience Education
See arm/group description

Locations

Country	Name	City	State
United States	University of Nevada Las Vegas - Department of Physical Therapy	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
University of Nevada, Las Vegas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Numeric Pain Rating Scale	Change from Baseline to 1 month, 3 months and 6 months post-surgery
Primary	Function	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	Change from Baseline to 1 month, 3 months and 6 months post-surgery
Primary	Pain Catastrophization	Pain Catastrophization Scale	Change from Baseline to 1 month, 3 months and 6 months post-surgery
Primary	Fear of movement	Tampa Scale of Kinesiophobia	Change from Baseline to 1 month, 3 months and 6 months post-surgery
Secondary	Opioid Use	Oral Morphine Dose Equivalents	Change at 1 month
Secondary	Healthcare Expenses	Costs associated with healthcare utilization	Change from Baseline to 1 month, 3 months and 6 months post-surgery
Secondary	Patient Satisfaction	Likert questions	Change at 1 month, 3 months and 6 months post-surgery