Pain Neuroscience Education in Total Knee Arthroplasty

NCT03231566 | Completed

• 1 other identifier: 710848-3
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Total Knee Replacement

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Opioid Use

  Change at 1 month

• Healthcare Expenses

  Change from Baseline to 1 month, 3 months and 6 months post-surgery

• Patient Satisfaction

  Change at 1 month, 3 months and 6 months post-surgery

Study Arms (2)

Usual education control group (CG)

ACTIVE COMPARATOR

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

Experimental group (EG)

EXPERIMENTAL

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

Interventions

Pain Neuroscience Education BEHAVIORAL

See arm/group description

Experimental group (EG); Usual education control group (CG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Nevada, Las Vegas: lead

Study Sites (1)

University of Nevada Las Vegas - Department of Physical Therapy

Las Vegas, Nevada, 89154, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcome measures were mailed by patients in prepaid envelopes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 13, 2017
• First Posted: July 27, 2017
• Study Start: February 28, 2015
• Primary Completion: March 20, 2017
• Study Completion: March 20, 2017
• Last Updated: July 27, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)