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Completed

NCT Number: NCT05928351

Pain Neuroscience 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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ahi Evran University

Kırşehir, Central, 40080, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Pain severity

    Time frame: Baseline

    Visual Analogue Scale (0-10, higher means worse)

  2. Pain severity change is being assessed

    Time frame: 6 week

    Visual Analogue Scale (0-10, higher means worse)

  3. Pain and Function

    Time frame: Baseline

    Knee Injury and Osteoarthritis Outcome Score (0-100, higher means better)

  4. Pain and Function change are being assessed

    Time frame: 6 week

    Knee Injury and Osteoarthritis Outcome Score (0-100, higher means better)

  5. Pain and Function

    Time frame: Baseline

    Western Ontario and McMaster Universities Arthritis Index (0-96, higher means worse)

  6. Pain and Function change are being assessed

    Time frame: 6 week

    Western Ontario and McMaster Universities Arthritis Index (0-96, higher means worse)

Secondary outcomes

  1. Pain Catastrophizing

    Time frame: Baseline

    Pain Catastrophizing Scale (0-52, higher means worse)

  2. Pain Catastrophizing change is being assessed

    Time frame: 6 week

    Pain Catastrophizing Scale (0-52, higher means worse)

  3. Kinesiophobia

    Time frame: Baseline

    Tampa Scale of Kinesiophobia (17-68, higher means worse)

  4. Kinesiophobia change is being assessed

    Time frame: 6 week

    Tampa Scale of Kinesiophobia (17-68, higher means worse)

  5. Level of quality of life

    Time frame: Baseline

    Short Form-12 (0-100, higher means better)

  6. Level of quality of life change is being assessed

    Time frame: 6 week

    Short Form-12 (0-100, higher means better)

  7. Anxiety and Depression

    Time frame: Baseline

    Hospital Anxiety Depression Scale (0-21, higher means worse)

  8. Anxiety and Depression change is being assessed

    Time frame: 6 week

    Hospital Anxiety Depression Scale (0-21, higher means worse)

  9. Physical Function

    Time frame: Baseline

    40 meter walking test (in seconds, less is better)

  10. Physical Function change is being assessed

    Time frame: 6 week

    40 meter walking test (in seconds, less is better)

Sponsors and collaborators

Lead sponsor

Ahi Evran University Education and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 3, 2023
Registry last updated
Jan 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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