Effectiveness of Pain Science Education in People With Symptomatic Knee Osteoarthritis

NCT05649995 | Completed

• 1 other identifier: 092022160
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study is to determine the effectiveness of the program integrated with pain science education for people with painful knee osteoarthritis (OA). Another purpose of the study is to evaluate whether the program integrated with pain science education is more effective than the program integrated with biomedical education.

Conditions

Osteo Arthritis Knee

Keywords

Osteoarthritis; pain; knee; education

Outcome Measures

Primary Outcomes (4)

• Changes in pain intensity

  Assessed using the numeric rating scale that assesses pain intensity (range 0-10 and higher values are indicative of higher pain intensity)

  Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the face-to-face sessions); T2 (within 1 week after the end of the telerehabilitation sessions) T3 (within 7 week after the end of the telerehabilitation sessions)

• Changes in pain frequency

  Assessed using a closed question about knee pain frequency in the last week (How many times in the last week have you felt this pain?". The answer options are: Never, rarely (once a week) occasionally (2 to 3 times a week), often (more than 3 times a week) and always.

  Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the face-to-face sessions); T2 (within 1 week after the end of the telerehabilitation sessions)

• Changes in WOMAC (Western Ontario and McMaster Universities) index

  womac will be used to assess pain, stiffness and physical function

  Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the face-to-face sessions); T2 (within 1 week after the end of the telerehabilitation sessions) T3 (within 7 week after the end of the telerehabilitation sessions)

• Changes in the level of pain catastrophizing

  Assessed using the Pain Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)

  Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the face-to-face sessions); T2 (within 1 week after the end of the telerehabilitation sessions)

Secondary Outcomes (7)

• Changes in fear of movement

  Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the face-to-face sessions); T2 (within 1 week after the end of the telerehabilitation sessions)

• Changes in health-related quality of life

  Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the face-to-face sessions); T2 (within 1 week after the end of the telerehabilitation sessions)

• Changes in physical activity level

  Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the face-to-face sessions); T2 (within 1 week after the end of the telerehabilitation sessions)

• Changes in sleep quality level

  Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the face-to-face sessions); T2 (within 1 week after the end of the telerehabilitation sessions)

• Changes in sedentary time and sedentary behavior

  Baseline (T0, 1 week before beginning of the study); T1 (within 1 week after the end of the face-to-face sessions); T2 (within 1 week after the end of the telerehabilitation sessions)

Study Arms (2)

Pain science education group

EXPERIMENTAL

the program integrated with pain science education (exercise, walking program and recommendations for reducing sedentary behaviors)

Other: Pain science education driven physiotherapy program

Biomedical education group

EXPERIMENTAL

the program integrated with biomedical education (exercise, walking program and recommendations for reducing sedentary behaviors)

Other: Biomedical education driven physiotherapy program

Interventions

Pain science education driven physiotherapy program OTHER

Pain science training will be carried out as described by Moseley and Butler. Topics covered within the scope of pain science education are planned to include: neurophysiology of pain, synapses, peripheral sensitization, central sensitization, plasticity of the nervous system. The aim of the training will be to teach participants that pain is a multifactorial experience rather than just tissue injury. Participants in this group will be told about the importance of physical activity integrated with pain science education (i.e., explaining that physical activity is the key to bioplasticity and causing changes in our system) and why sedentary behaviors should be reduced (reducing sedentary behaviors reduces the overprotectiveness of the pain system).

Pain science education group

Biomedical education driven physiotherapy program OTHER

Participants in this group will be planned to increase their knowledge of knee anatomy, knowledge of knee OA and knee OA risk factors, and the importance of increasing physical activity and reducing sedentary behavior in reducing osteoarthritic pain and improving overall health. The importance of physical activity by integrating it with biomedical education (as physical activity can help strengthen muscles, protect joint function, and improve sleep and general health) and the necessity of reducing sedentary behaviors will be discussed within the framework of biomedical education.The main difference of standard education from pain science education will be that it does not contain information about pain mechanisms mentioned in pain science education.

Biomedical education group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having been diagnosed with knee osteoarthritis according to the criteria of the American College of Rheumatology (ACR).
• Being between the ages of 45-65
• Having knee pain lasting at least 6 months
• Average knee pain intensity of ≥4 on 11- point numeric rating scale in the past week
• Having Turkish as mother tongue
• Being literate

You may not qualify if:

• Having health problems (eg heart or lung disease) that prevent safe participation in physical activity interventions as listed in the American College of Sports Medicine Guidelines.
• Neurological disorders affecting the lower extremity (eg multiple sclerosis or stroke)
• Using an assistive device
• Being diagnosed with OA in joint areas other than the knee joint
• Presence of inflammatory arthritis (including rheumatoid arthritis)
• Presence of any condition that affects decision making/memory (eg Alzheimer's, dementia)
• Knee replacement/surgery planning for the next 3 months

Sponsors & Collaborators

• Marmara University: lead

Study Sites (2)

Marmara University

Istanbul, Maltepe, Turkey (Türkiye)

Location

Marmara University Pendik Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis; Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hilal Ata Tay

  Marmara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 14, 2022
• Study Start: January 2, 2023
• Primary Completion: October 6, 2023
• Study Completion: December 1, 2023
• Last Updated: December 7, 2023

Record last verified: 2023-12

Locations

TU (2)