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Clinical Trials/NCT05928351
NCT05928351
Completed
Not Applicable

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

Ahi Evran University Education and Research Hospital1 site in 1 country34 target enrollmentJune 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis, Knee
Sponsor
Ahi Evran University Education and Research Hospital
Enrollment
34
Locations
1
Primary Endpoint
Pain severity change is being assessed
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2023
End Date
December 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ahi Evran University Education and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Abdulhamit Tayfur

Principal Investigator

Ahi Evran University Education and Research Hospital

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

Outcomes

Primary Outcomes

Pain severity change is being assessed

Time Frame: 6 week

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

Pain severity

Time Frame: Baseline

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

Pain and Function

Time Frame: Baseline

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

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

  • Pain Catastrophizing change is being assessed(6 week)
  • Kinesiophobia change is being assessed(6 week)
  • Level of quality of life(Baseline)
  • Level of quality of life change is being assessed(6 week)
  • Pain Catastrophizing(Baseline)
  • Anxiety and Depression(Baseline)
  • Anxiety and Depression change is being assessed(6 week)
  • Kinesiophobia(Baseline)
  • Physical Function(Baseline)
  • Physical Function change is being assessed(6 week)

Study Sites (1)

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