Pain Neuroscience Education in Patients With Total Knee Arthroplasty

Investigation of the Efficacy of Neuroscience Pain Education in Patients With Total Knee Arthroplasty

The aim of Pain Neuroscience Education (PNE) is to explain to patients the biological and physiological processes involved in a pain experience and, more importantly, defocus the issues associated with the anatomical structures. PNE provides compelling evidence in reducing pain, disability, pain catastrophization, and limited physical movement in musculoskeletal problems. Knee osteoarthritis (KOA) is a very common painful musculoskeletal problem, especially in people over 50 years old, and lead to decrease in knee range of motion. Despite costly arthroscopic surgeries and long-term physiotherapy treatments, poor outcomes are common. The lack of satisfactory results suggests that some practices should be revised. Although PNE could be useful as an intervention, to our knowledge, there is no randomized controlled trial in the literature investigating the effects of PNE in patients with a KOA. Therefore, we aimed to examine the effectiveness of PNE on clinical outcomes in patients with KOA.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Other: Pain Neuroscience Education; Other: Standard Physiotherapy Program (SPP)

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Central
    • Kırşehir, Central, Turkey, 40080
      • Ahi Evran University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Having a body mass index between 19-40 kg/m2,
• Having had a unilateral TKA,
• Knee pain score to be 4 and above daily according to the visual analog scale,
• Ability to read, speak and understand Turkish.

Exclusion Criteria:

• Prosthesis disorders requiring re-surgery,
• Having visual, auditory and cognitive impairment,
• Secondary TKA such as rheumatoid arthritis,
• Acute pain,
• Pregnancy, drug and alcohol use,
• Having bilateral TKA,
• Not volunteering to participate in the study

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PNE Group; Pain Neuroscience Education + Standard Physiotherapy Program	Other: Pain Neuroscience Education; The experimental group will follow a PNE protocol based on previous procedure for 6 weeks in addition to the standard physiotherapy program (SPP) in postoperative period. Each PNE session will take 45-60 min. PNE will be conducted in line with international guidelines and covered the neurophysiology of pain, transition from acute to chronic pain, and the nervous system ability to modulate the pain experience.; Other: Standard Physiotherapy Program (SPP); The control group will follow a SPP. The 45-minute-long treatment sessions will be held 5 days per week. The treatment program will be organized in 3 periods as 0-2 weeks, 3-4 weeks and 5-6 weeks. The overall treatment program will include scar massage, patellar mobilization, coldpack, ankle pump, quadriceps and hamstring strengthening, hip range of motion, hip strengthening exercises, squat, ascending and descending stairs, walking training. All exercises will be 10 repetitions x 2 sets.
Active Comparator: Control Group; Standard Physiotherapy Program	Other: Standard Physiotherapy Program (SPP); The control group will follow a SPP. The 45-minute-long treatment sessions will be held 5 days per week. The treatment program will be organized in 3 periods as 0-2 weeks, 3-4 weeks and 5-6 weeks. The overall treatment program will include scar massage, patellar mobilization, coldpack, ankle pump, quadriceps and hamstring strengthening, hip range of motion, hip strengthening exercises, squat, ascending and descending stairs, walking training. All exercises will be 10 repetitions x 2 sets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain severity	Visual Analogue Scale (0-10, higher means worse)	Baseline
Pain severity change is being assessed	Visual Analogue Scale (0-10, higher means worse)	6 week
Pain and Function	Knee Injury and Osteoarthritis Outcome Score (0-100, higher means better)	Baseline
Pain and Function change are being assessed	Knee Injury and Osteoarthritis Outcome Score (0-100, higher means better)	6 week
Pain and Function	Western Ontario and McMaster Universities Arthritis Index (0-96, higher means worse)	Baseline
Pain and Function change are being assessed	Western Ontario and McMaster Universities Arthritis Index (0-96, higher means worse)	6 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Catastrophizing	Pain Catastrophizing Scale (0-52, higher means worse)	Baseline
Pain Catastrophizing change is being assessed	Pain Catastrophizing Scale (0-52, higher means worse)	6 week
Kinesiophobia	Tampa Scale of Kinesiophobia (17-68, higher means worse)	Baseline
Kinesiophobia change is being assessed	Tampa Scale of Kinesiophobia (17-68, higher means worse)	6 week
Level of quality of life	Short Form-12 (0-100, higher means better)	Baseline
Level of quality of life change is being assessed	Short Form-12 (0-100, higher means better)	6 week
Anxiety and Depression	Hospital Anxiety Depression Scale (0-21, higher means worse)	Baseline
Anxiety and Depression change is being assessed	Hospital Anxiety Depression Scale (0-21, higher means worse)	6 week
Physical Function	40 meter walking test (in seconds, less is better)	Baseline
Physical Function change is being assessed	40 meter walking test (in seconds, less is better)	6 week

Collaborators and Investigators

• Sponsor: Ahi Evran University Education and Research Hospital

Publications and helpful links

General Publications

• Louw A, Diener I, Butler DS, Puentedura EJ. The effect of neuroscience education on pain, disability, anxiety, and stress in chronic musculoskeletal pain. Arch Phys Med Rehabil. 2011 Dec;92(12):2041-56. doi: 10.1016/j.apmr.2011.07.198.
• Louw A PT, PhD, Zimney K PT, DPT, Reed J PT, DPT, Landers M PT, DPT, PhD, Puentedura EJ PT, DPT, PhD. Immediate preoperative outcomes of pain neuroscience education for patients undergoing total knee arthroplasty: A case series. Physiother Theory Pract. 2019 Jun;35(6):543-553. doi: 10.1080/09593985.2018.1455120. Epub 2018 Mar 28.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): November 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: June 15, 2023
• First Submitted That Met QC Criteria: June 23, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Estimated): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 13, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: osteoarthritis; knee; pain neuroscience education
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 2023/605

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