Effectiveness of Pain Science Education in People With Symptomatic Knee Osteoarthritis: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Changes in WOMAC (Western Ontario and McMaster Universities) index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Changes in WOMAC (Western Ontario and McMaster Universities) index
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
次要结局
- Evaluation of Satisfaction Level from Pain Science Education(T1 (within 1 week after the end of the face-to-face sessions))
- 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 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))
- 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))
- 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 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))
研究者
Hilal Ata Tay
Principal investigator
Marmara University