Pain Neuroscience Education in Patients With Total Knee Arthroplasty

NCT05928351 | Completed

• 1 other identifier: 2023/605
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis, Knee

Keywords

pain neuroscience education; knee; osteoarthritis

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (10)

• Pain Catastrophizing

  Baseline

• Pain Catastrophizing change is being assessed

  6 week

• Kinesiophobia

  Baseline

• Kinesiophobia change is being assessed

  6 week

• Level of quality of life

  Baseline

Study Arms (2)

PNE Group

EXPERIMENTAL

Pain Neuroscience Education + Standard Physiotherapy Program

Other: Pain Neuroscience Education; Other: Standard Physiotherapy Program (SPP)

Control Group

ACTIVE COMPARATOR

Standard Physiotherapy Program

Other: Standard Physiotherapy Program (SPP)

Interventions

Pain Neuroscience Education OTHER

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.

PNE Group

Standard Physiotherapy Program (SPP) OTHER

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.

Control Group; PNE Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ahi Evran University Education and Research Hospital: lead

Study Sites (1)

Ahi Evran University

Kırşehir, Central, 40080, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 22133255 BACKGROUND

• 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.

  PMID: 29589782 BACKGROUND

• Tayfur A, Ozyurt F, Kodak MI, Cakmak MF, Ozsoy G, Cigdem Karacay B, Ozsoy I, Basat HC, Kararti C. The efficacy of pain neuroscience education in patients after total knee arthroplasty: a single blind randomized controlled trial. Physiother Theory Pract. 2025 Dec;41(12):2513-2523. doi: 10.1080/09593985.2025.2526025. Epub 2025 Jul 1.

  PMID: 40590360 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: the blinded assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: July 3, 2023
• Study Start: June 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)