The Effect of Online Therapeutic Neuroscience Education Added to Conventional Physiotherapy Program on Clinical Outcomes, Treatment Expectations and Satisfaction Levels in Patients With Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Kinesiophobia
研究概览
简要总结
This study aims to evaluate the effects of online Therapeutic Neuroscience Education (TNE) combined with a 6-week conventional physiotherapy program on pain, disability, kinesiophobia, functionality, treatment expectations, and satisfaction in individuals with chronic low back pain (CLBP). The goal is to improve participants' understanding of chronic pain, reduce fear and avoidance behaviors, enhance movement and functionality, and increase treatment satisfaction. The study also seeks to provide a lasting educational resource.
TNE focuses on educating patients about pain neurophysiology, aiming to reduce pain, improve function, and shift perceptions about pain through interactive sessions involving diagrams, metaphors, and examples. Despite evidence supporting TNE's effectiveness for chronic pain conditions, no studies have evaluated its online application or long-term effects.
The study will include 60 volunteers with CLBP (ages 20-60), randomized into two groups: one receiving conventional physiotherapy and online TNE, and the other receiving conventional treatment alone. The TNE group will participate in six weekly 45-minute online sessions, covering topics like pain neurophysiology, biopsychosocial factors, and pain coping strategies, without addressing anatomical or emotional aspects.
Educational materials, including resources adapted from "Why You Hurt" will be presented to the TNE group. Conventional physiotherapy includes hot packs, ultrasound, TENS, and home exercises for both groups.
Clinical outcomes will be assessed by a blinded researcher at multiple time points using tools such as pain and disability scales, kinesiophobia measures, functional tests, and questionnaires on treatment expectations and satisfaction. The study is significant for its innovative approach in examining the clinical and long-term effectiveness of online TNE as part of CLBP management.
详细描述
The aim of this study is to determine the effects of therapeutic neuroscience education applied online in addition to a 6-week conventional physiotherapy program on pain, disability, kinesiophobia, functionality, treatment expectations and satisfaction in individuals with chronic low back pain.
At the end of the study, it is aimed to help individuals with chronic low back pain better understand the biological process underlying chronic pain conditions with therapeutic neuroscience education; to increase treatment expectations and satisfaction by achieving therapeutic effects such as reducing fear associated with pain and musculoskeletal injuries, and increasing movement and functionality.
In individuals with chronic low back pain, the disease state, fear and avoidance behavior related to the treatment process, catastrophizing, inappropriate beliefs and psychosocial factors (yellow flags) cause pain to increase and become chronic.
Therapeutic Neuroscience Education (TNE) is an information application applied by a physiotherapist with therapeutic purposes such as reducing pain, improving function, helping the individual understand the cause of their pain, and reconceptualizing pain. It is used to raise awareness about pain and the coding of pain in the brain, to improve the individual's health behavior and health status, and to stimulate the cognitive infrastructure. TNE is a method applied in the form of one-on-one seminar format, focused on pain neurophysiology, and in the form of speaking sessions. Within the scope of these speaking sessions, pictures, diagrams, graphs, examples, metaphors, and homework assignments explaining the neurophysiology of pain are used.
There are findings that Therapeutic Neuroscience Education improves pain and disability in various populations with chronic pain (such as low back/neck pain, fibromyalgia), but there is no protocol in the literature showing the effectiveness of the TNE program given online.
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 (Outcomes Assessor)
盲法说明
Outcomes assessor will be blinded.
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals aged 20-60
- •Having received a score of 24 or above in the Mini-Mental Status Assessment
- •Having internet access
- •Having back pain for more than 3 months
- •Having pain between 3-8 on the Numerical Pain Scale
- •Individuals with chronic back pain whose symptoms are not radicular
排除标准
- •Having other orthopedic/neurological disorders that will affect the evaluation and treatment
- •Patients with vertebral compression fractures on MRI and lumbar radiography
- •Patients with unstable neurological findings
- •Patients using analgesic medication during treatment
- •Patients with rheumatological and inflammatory diseases
- •Patients with acute trauma
- •Patients who are pregnant
- •Patients who have undergone lumbar region surgery
研究组 & 干预措施
Experimental
These participants will receive online Therapeutic Neuroscience Education with conventional physiotherapy program.
干预措施: Therapeutic Neuroscience Education (Other)
Experimental
These participants will receive online Therapeutic Neuroscience Education with conventional physiotherapy program.
干预措施: Conventional Program (Other)
Control
Control group will receive only conventional physiotherapy program.
干预措施: Conventional Program (Other)
结局指标
主要结局
Kinesiophobia
时间窗: T0 (baseline), T1 (3rd week), T2 (6th week) and T3 (6 month follow up)
Tampa Scale of Kinesiophobia will be used to assess kinesiophobia, which is an anxiety state that develops against activity and physical movement. This scale was developed to distinguish between non-excessive fear and phobia in individuals with chronic musculoskeletal pain. It is widely used in the literature to assess fear and anxiety related to movement. The scale consists of 17 items covering work-related activities, injury, re-injury, and fear-avoidance parameters and scored between 17-68. High scores obtained from the scale indicate that the individual's level of kinesiophobia has increased. Studies conducted on patients with low back and neck pain have revealed that the test-retest reliability ICC value of the Turkish version of the scale is 0.80.
Pain Level
时间窗: T0 (baseline), T1 (3rd week), T2 (6th week) and T3 (6 month follow up)
Numeric Pain Scale will be used for assessing the participants' pain levels. Participants will be asked to determine the number that best describes their pain on a scale of 0 to 10, where 0 = no pain and 10 = unbearable pain. The Numerical Pain Scale is a valid and reliable measurement method for subjective pain intensity assessment. Rest, activity and night pain will be located on a horizontal stripe that the participant will mark. High numbers indicated higher pain levels.
Pain Catastrophizing
时间窗: T0 (baseline), T1 (3rd week), T2 (6th week) and T3 (6 month follow up)
The Pain Catastrophizing Scale will be used to assess participants' pain catastrophizing. This scale is a self-report questionnaire that assesses unhelpful coping strategies and catastrophizing thoughts about pain and injury and has strong validity and reliability. The scale consists of 13 questions, each question is scored between 0 and 4. The lowest possible score is 0, the highest score is 52. As the score increases (e.g. \>10), pain catastrophizing thoughts increase. The Turkish validity and reliability study of the questionnaire was conducted and Cronbach's alpha value was reported as 0.955 and ICC value as 0.830.
次要结局
- Disability(T0 (baseline), T1 (3rd week), T2 (6th week) and T3 (6 month follow up))
- Physical Function(T0 (baseline), T1 (3rd week), T2 (6th week) and T3 (6 month follow up))
- Treatment Expectation(T0 (baseline), T1 (3rd week))
- Treatment Satisfaction(T2 (6th week) and T3 (6 month follow up))
研究者
Furkan Çakır
Principal Investigator
Istanbul Bilgi University