search
Back to results

Pain Neuroscience Education in Patients With Total Knee Arthroplasty

Primary Purpose

Osteoarthritis, Knee

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pain Neuroscience Education
Standard Physiotherapy Program (SPP)
Sponsored by
Ahi Evran University Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring pain neuroscience education, knee, osteoarthritis

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ahi Evran UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PNE Group

Control Group

Arm Description

Pain Neuroscience Education + Standard Physiotherapy Program

Standard Physiotherapy Program

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 15, 2023
Last Updated
June 23, 2023
Sponsor
Ahi Evran University Education and Research Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05928351
Brief Title
Pain Neuroscience Education in Patients With Total Knee Arthroplasty
Official Title
Investigation of the Efficacy of Neuroscience Pain Education in Patients With Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ahi Evran University Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
pain neuroscience education, knee, osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized
Masking
Outcomes Assessor
Masking Description
the blinded assessor
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PNE Group
Arm Type
Experimental
Arm Description
Pain Neuroscience Education + Standard Physiotherapy Program
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Standard Physiotherapy Program
Intervention Type
Other
Intervention Name(s)
Pain Neuroscience Education
Intervention Description
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
Intervention Name(s)
Standard Physiotherapy Program (SPP)
Intervention Description
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 Outcome Measure Information:
Title
Pain severity
Description
Visual Analogue Scale (0-10, higher means worse)
Time Frame
Baseline
Title
Pain severity change is being assessed
Description
Visual Analogue Scale (0-10, higher means worse)
Time Frame
6 week
Title
Pain and Function
Description
Knee Injury and Osteoarthritis Outcome Score (0-100, higher means better)
Time Frame
Baseline
Title
Pain and Function change are being assessed
Description
Knee Injury and Osteoarthritis Outcome Score (0-100, higher means better)
Time Frame
6 week
Title
Pain and Function
Description
Western Ontario and McMaster Universities Arthritis Index (0-96, higher means worse)
Time Frame
Baseline
Title
Pain and Function change are being assessed
Description
Western Ontario and McMaster Universities Arthritis Index (0-96, higher means worse)
Time Frame
6 week
Secondary Outcome Measure Information:
Title
Pain Catastrophizing
Description
Pain Catastrophizing Scale (0-52, higher means worse)
Time Frame
Baseline
Title
Pain Catastrophizing change is being assessed
Description
Pain Catastrophizing Scale (0-52, higher means worse)
Time Frame
6 week
Title
Kinesiophobia
Description
Tampa Scale of Kinesiophobia (17-68, higher means worse)
Time Frame
Baseline
Title
Kinesiophobia change is being assessed
Description
Tampa Scale of Kinesiophobia (17-68, higher means worse)
Time Frame
6 week
Title
Level of quality of life
Description
Short Form-12 (0-100, higher means better)
Time Frame
Baseline
Title
Level of quality of life change is being assessed
Description
Short Form-12 (0-100, higher means better)
Time Frame
6 week
Title
Anxiety and Depression
Description
Hospital Anxiety Depression Scale (0-21, higher means worse)
Time Frame
Baseline
Title
Anxiety and Depression change is being assessed
Description
Hospital Anxiety Depression Scale (0-21, higher means worse)
Time Frame
6 week
Title
Physical Function
Description
40 meter walking test (in seconds, less is better)
Time Frame
Baseline
Title
Physical Function change is being assessed
Description
40 meter walking test (in seconds, less is better)
Time Frame
6 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abdulhamit Tayfur, PhD
Phone
05075383162
Ext
+90
Email
abdulhamit.tayfur@ahievran.edu.tr
Facility Information:
Facility Name
Ahi Evran University
City
Kırşehir
State/Province
Central
ZIP/Postal Code
40080
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdulhamit Tayfur, PhD
Phone
05075383162
Ext
+90
Email
abdulhamit.tayfur@ahievran.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22133255
Citation
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.
Results Reference
background
PubMed Identifier
29589782
Citation
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.
Results Reference
background

Learn more about this trial

Pain Neuroscience Education in Patients With Total Knee Arthroplasty

We'll reach out to this number within 24 hrs