Pain Neuroscience Education in Patients With Total Knee Arthroplasty

NCT ID: NCT05928351

Last Updated: 2024-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2023-12-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PNE Group

Pain Neuroscience Education + Standard Physiotherapy Program

Group Type: EXPERIMENTAL

Pain Neuroscience Education

Intervention Type: 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.

Standard Physiotherapy Program (SPP)

Intervention Type: 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

Standard Physiotherapy Program

Group Type: ACTIVE_COMPARATOR

Standard Physiotherapy Program (SPP)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ahi Evran University Education and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Abdulhamit Tayfur

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ahi Evran University

Kırşehir, Central, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 22133255 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29589782 (View on PubMed)

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 Jul 1:1-11. doi: 10.1080/09593985.2025.2526025. Online ahead of print.

Reference Type: DERIVED

PMID: 40590360 (View on PubMed)

Other Identifiers

2023/605

Identifier Type: -

Identifier Source: org_study_id