Clinical trial NCT05649995: Effectiveness of Pain Science Education in People With Symptomatic Knee Osteoarthritis
Official title: Effectiveness of Pain Science Education in People With Symptomatic Knee Osteoarthritis: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteo Arthritis Knee
Keywords: Osteoarthritis
pain
knee
education
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2022-12-14
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in pain intensity
timeFrame: 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)
measure: Changes in pain frequency
timeFrame: 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)
measure: Changes in WOMAC (Western Ontario and McMaster Universities) index
timeFrame: 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)
measure: Changes in the level of pain catastrophizing
timeFrame: 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:
measure: Changes in fear of movement
timeFrame: 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)
measure: Changes in health-related quality of life
timeFrame: 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)
measure: Changes in physical activity level
timeFrame: 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)
measure: Changes in sleep quality level
timeFrame: 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)
measure: Changes in sedentary time and sedentary behavior
timeFrame: 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)
measure: Evaluation of Satisfaction Level from Pain Science Education
timeFrame: T1 (within 1 week after the end of the face-to-face sessions)
measure: Adherence to rehabilitation program
timeFrame: 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)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University
state: Maltepe
city: Istanbul
country: Turkey
facility: Marmara University Pendik Training and Research Hospital
Study officials:
affiliation: Marmara University
name: Hilal Ata Tay
role: PRINCIPAL_INVESTIGATOR
References: