The Effect of Visual Feedback Based Clinical Monitoring Software on Clinical and Psychosocial Symptoms in Patients With Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Visual Analog Scale
研究概览
简要总结
The aim of this randomised controlled trial is to compare the effectiveness of two different telerehabilitation assessment methods in patients with chronic low back pain. The control group will receive a video exercise-based rehabilitation protocol with telerehabilitation. The intervention group will be followed up with the same protocol plus symptom monitoring software called PhysioAnalyst which provides visual feedback. The evaluation of outcome measures will be performed on the control group through the PhysioAnalist programme without visual feedback and on the intervention group through the PhysioAnalist programme with visual feedback.
详细描述
Individuals with chronic low back pain will be divided into 2 groups by randomisation software (https://ctrandomization.cancer.gov/tool/). The control group will be given video exercises on the online platform. Initial, interim and final evaluations will be performed by filling in the patient-reported outcome measures through the PhysioAnalyst programme without patient feedback. The intervention group will be given the video exercise programme on the same online platform. Initial, intermediate and final assessments will be performed with our self-developed PhysioAnalyst software using visual feedback tools. The video exercises given to the participants will include Williams, McKenzie exercises and core strengthening exercises. Visual Analogue Scale pain score, Nottingham Health Profile, Pain Catastrophising Scale, Oswestry Disability Index, Telehealth Usability Questionnaire, Telemedicine Satisfaction Questionnaire, Exercise Adherence Rating Scale will be applied.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with low back pain for more than 3 months and diagnosed with chronic low back pain
- •Adult patients aged between 18 and 65 years
- •Individuals without a radicular symptom
- •Patients who can understand and respond to verbal commands and who do not have hearing or speech problems or psychiatric problems that may prevent communication
- •Patients who have devices with sufficient requirements to receive the exercise programme and assessments offered by telerehabilitation
排除标准
- •Spinal surgery history
- •Presence of malignancy
- •Presence of other orthopaedic and/or neurological diseases that may affect the assessment and treatment
- •Pregnant women or women with suspected pregnancy
- •Patients who did not sign the consent form required for participation in the study
结局指标
主要结局
Visual Analog Scale
时间窗: Change from Baseline Visual Analog Scale at 8 weeks
On a 10 cm straight line or numerical and visual scale, the patient is asked to mark the pain felt (0: no pain, 10: unbearable pain).
Nottingham Health Profile
时间窗: Change from Baseline Nottingham Health Profile at 8 weeks
The measure consists of six different subcategories testing physical activity, energy, pain, social isolation, sleep and emotional responses. Scores range from 0 to 100 for each subcategory. Low scores indicate a low impact of the complaint and high scores indicate a high impact of the complaint.
Pain Catastrophising Scale
时间窗: Change from Baseline Pain Catastrophising Scale at 8 weeks
Scale is used to assess the patient's feelings and thoughts about pain and disaster. The total score ranges from 0 to 52 points. A high score indicates a bad situation.
Oswestry Disability Index
时间窗: Change from Baseline Oswestry Disability Index at 8 weeks
The Oswestry Disability Index consists of 10 questions measuring functional status. Each question is evaluated between 0 and 5 points and the total maximum score is 50. Higher score indicates more disability.
次要结局
- Exercise Adherence Rating Scale(Change from Exercise Adherence Rating Scale at 8 weeks)
- Telehealth Usability Questionnaire(Change from Baseline Telehealth Usability Questionnaire at 8 weeks)
- Telemedicine Satisfaction Questionnaire(Change from Baseline Telemedicine Satisfaction Questionnaire at 8 weeks)
研究者
Fatih Ozden
Assistant Professor
Muğla Sıtkı Koçman University