Effectiveness of Pain Science Education in People With Symptomatic Knee Osteoarthritis

NCT ID: NCT05649995

Last Updated: 2023-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-02
• Study Completion Date: 2023-12-01

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.

Detailed Description

Contemporary pain science education provides a scientific basis for the increased sensitivity produced in chronic pain due to adaptations in the central nervous system. In the literature, pain science education has been shown to reduce unhelpful pain beliefs and improve pain, function, and disability in several chronic musculoskeletal pain states, but data specific to knee OA are lacking.

Patients with knee osteoarthritis who meet the inclusion criteria and agree to participate in the study will be included. The participants will be randomly divided into two groups. These groups are: a) intervention group, where the program integrated with pain science education and b)control group, where the program integrated with biomedical education.

Three weeks of face-to-face sessions in both groups will be followed by three weeks of telerehabilitation sessions. Telerehabilitation sessions will be applied as phone calls or video conference sessions, according to the participant's request. All sessions will be conducted one-on-one.

Face-to-face sessions for both groups:

• 3 sessions in total,
• 1 day a week for 3 weeks,
• Each session will last approximately 60 minutes for the control group and the intervention group.
• Each face-to-face session will include education and physiotherapy program. Biomedical education for the control group and pain science education for the intervention group will be applied. Visuals and presentations will be used in the education of both groups. The presentations and visuals that will be used in pain science education and biomedical education will be different. The physiotherapy program will be the same for both groups. Physiotherapy program will be applied after education in both groups. In the physiotherapy program, all participants will be given knee exercises and will be asked to take a walk twice a week as homework and suggestions will be made to reduce their sedentary behavior. The exercises given to both groups will be the same.

Telerehabilitation sessions for both groups:

• 3 sessions in total,
• 1 day a week for 3 weeks,
• Each session is approximately 15-20 minutes,
• Each session will include education, recommendations (especially about increasing physical activity and reducing sedentary behaviour), answering questions if any, and discussion.

The homework and suggestions to be given to the participants in the intervention group will be integrated with the pain science education, while the homework and suggestions to be given to the participants in the control group will be integrated with the biomedical education. For example, it will be explained to a participant in the intervention group that walking will regulate increased sensitivity in the central nervous system and ensure plasticity (using stories, examples in a way that the participant can understand). It will be explained to the participant in the control group that walking will strengthen their muscles and will be beneficial for general health and joint health.

Conditions

Osteo Arthritis Knee

Keywords

Osteoarthritis; pain; knee; education

Study Design

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

Study Groups

Pain science education group

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

Group Type: EXPERIMENTAL

Pain science education driven physiotherapy program

Intervention Type: 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).

Biomedical education group

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

Group Type: EXPERIMENTAL

Biomedical education driven physiotherapy program

Intervention Type: 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.

Interventions

Pain science education driven physiotherapy program

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).

Intervention Type: OTHER

Biomedical education driven physiotherapy program

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Hilal Ata Tay

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hilal Ata Tay

Role: PRINCIPAL_INVESTIGATOR

Marmara University

Locations

Marmara University

Istanbul, Maltepe, Turkey (Türkiye)

Marmara University Pendik Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

092022160

Identifier Type: -

Identifier Source: org_study_id