Pain Neuroscience Education in Total Knee Arthroplasty

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

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

Study Overview

• Status: Completed
• Conditions: Total Knee Replacement
• Intervention / Treatment: Behavioral: Pain Neuroscience Education

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89154
      • University of Nevada Las Vegas - Department of Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual education control group (CG); The CG received the traditional hospital preoperative program, which was consistent with current preoperative TKA protocols. The CG received education covering anatomy of the knee joint, information about the joint replacement surgery, what to expect when they were admitted for surgery, what to expect immediately after surgery, pain medications, postoperative rehabilitation/physical therapy, etc. The CG received a hospital-based booklet with this information.	Behavioral: Pain Neuroscience Education; See arm/group description
Experimental: Experimental group (EG); The EG underwent an additional 30-minute group PNE program, followed by the usual preoperative education program from the hospital. The PNE program used in this TKA study was an adaptation of the PNE program developed for LS. The educational program was designed to be delivered by a physical therapist in a group session to patients prior to their TKA.	Behavioral: Pain Neuroscience Education; See arm/group description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Numeric Pain Rating Scale	Change from Baseline to 1 month, 3 months and 6 months post-surgery
Function	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	Change from Baseline to 1 month, 3 months and 6 months post-surgery
Pain Catastrophization	Pain Catastrophization Scale	Change from Baseline to 1 month, 3 months and 6 months post-surgery
Fear of movement	Tampa Scale of Kinesiophobia	Change from Baseline to 1 month, 3 months and 6 months post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Use	Oral Morphine Dose Equivalents	Change at 1 month
Healthcare Expenses	Costs associated with healthcare utilization	Change from Baseline to 1 month, 3 months and 6 months post-surgery
Patient Satisfaction	Likert questions	Change at 1 month, 3 months and 6 months post-surgery

Collaborators and Investigators

• Sponsor: University of Nevada, Las Vegas

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2015
• Primary Completion (Actual): March 20, 2017
• Study Completion (Actual): March 20, 2017

Study Registration Dates

• First Submitted: July 13, 2017
• First Submitted That Met QC Criteria: July 24, 2017
• First Posted (Actual): July 27, 2017

Study Record Updates

• Last Update Posted (Actual): July 27, 2017
• Last Update Submitted That Met QC Criteria: July 24, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 710848-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No