Effectiveness of Pain Science Education in People With Symptomatic Knee Osteoarthritis
- Conditions
- Osteo Arthritis Knee
- Interventions
- Other: Biomedical education driven physiotherapy programOther: Pain science education driven physiotherapy program
- Registration Number
- NCT05649995
- Lead Sponsor
- Marmara University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Biomedical education group Biomedical education driven physiotherapy program the program integrated with biomedical education (exercise, walking program and recommendations for reducing sedentary behaviors) Pain science education group Pain science education driven physiotherapy program the program integrated with pain science education (exercise, walking program and recommendations for reducing sedentary behaviors)
- Primary Outcome Measures
Name Time Method Changes in WOMAC (Western Ontario and McMaster Universities) index 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) womac will be used to assess pain, stiffness and physical function
Changes in 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) Assessed using the numeric rating scale that assesses pain intensity (range 0-10 and higher values are indicative of higher pain intensity)
Changes in pain frequency 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) 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.
Changes in the level of 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) Assessed using the Pain Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)
- Secondary Outcome Measures
Name Time Method Evaluation of Satisfaction Level from Pain Science Education T1 (within 1 week after the end of the face-to-face sessions) Satisfaction will be measured through visual analogue scale 0-100mm (0= not satisfied at all; 100 = very satisfied).
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) assessed using the Tampa Scale of Kinesiophobia, which assesses fear of movement (range: 13-52 and higher values are indicative of higher levels of fear of movement)
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) assessed using the International Physical Activity Questionnaire (IPAQ) -Short Form.
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) assessed using the Pittsburgh Sleep Quality Index (the higher score indicates worse sleep quality).
Adherence to rehabilitation program 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) Adherence to the walking program will be calculated by evaluating the duration and frequency of their walks each week.
Adherence to the knee exercises will be calculated by evaluating the number of the days they exercise in each week.
Adherence to recommendations about sedentary behavior will be calculated by evaluating the total time they sit and the frequency and duration of the breaks they take while sitting.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) assessed using the self-reported Short Form-12 questionnaire
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) The questions to be used in the evaluation of sedentary behaviors and sedentary time were adapted using the scale developed by Salmon (Salmon et al, 2003).
The sedentary behaviors of the participants will be questioned for their activities in eight different categories. These activities include: watching television, using a computer, reading a book, surfing the Internet on the phone, engaging in arts \& games \& hobbies (e.g. playing chess, knitting, sewing, drawing), chatting or socializing, just doing nothing to rest, to travel by vehicles such as buses, cars.
Trial Locations
- Locations (2)
Marmara University
🇹🇷Istanbul, Maltepe, Turkey
Marmara University Pendik Training and Research Hospital
🇹🇷Istanbul, Turkey