The Effectiveness of Pain Neuroscience Education for Patients With Mild to Moderate Carpal Tunnel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Boston Carpal Tunnel Questionnaire - Functional Status Scale
研究概览
简要总结
The goal of this clinical trial is to investigate the effects of Pain Neuroscience Education applied in the treatment of mild and moderate carpal tunnel syndrome (CTS).
The main question it aims to answer is: Does PNE have a therapeutic effect on carpal tunnel syndrome in clinical and ultrasonographic terms? Researchers will compare whether PNE creates a synergistic effect alongside home based exercise programs and splint application in mild to moderate CTS, and will objectively demonstrate potential benefits such as relief from pain and numbness.
详细描述
Carpal Tunnel Syndrome (CTS) is a common compressive neuropathy of the median nerve that presents with symptoms of numbness and tingling in the median nerve distribution of the hand. If symptoms are not treated early, they become chronic. Factors affecting the severity of chronic pain include; biological, psychological and social/environmental etc.
Pain neuroscience education is a treatment strategy that aims to teach patients about the effects of their beliefs and behaviors on the formation of their pain experiences. This education focuses on the role of the central nervous system in pain by raising awareness about the neurobiology and neurophysiology of pain. It focuses on remodelling the behavioral approach to pain perception rather than anatomical damage. This approach aims to reduce patients' fear and catastrophizing by helping them better understand pain. Various metaphors, examples, and visuals are used during PNE to help patients understand pain mechanisms. PNE is thought to have an impact not only on pain but also on disability, functionality, and quality of life. PNE has been documented to have a positive effect not only on pain but also on other important factors such as disability, functionality, and quality of life.
A clinical study has shown that adding PNE to a telerehabilitation program has some positive effects, such as a reduction in symptom severity in patients with carpal tunnel syndrome. However, the number of studies in the literature on the efficacy of PNE in carpal tunnel syndrome is limited to a single study and is based on subjective methods such as patient statements. Unlike the previous study, this study will use objective and innovative assessment methods such as ultrasonography, quantitative sensory test and examination to evaluate symptoms and function.
The evaluation methods used in the study will enable a more in-depth and reliable analysis of symptom management and recovery processes, thereby facilitating the collection of more accurate and reliable data. As there are no similar studies using objective evaluation methods, the methodological contributions of this study will be highly valuable. By offering an innovative approach to pain management and rehabilitation through conservative treatment, it will make significant contributions to both scientific literature and clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being 18 years of age or older
- •Having a diagnosis of mild or moderate CTS confirmed by ENMG
- •Having complaints of pain and numbness in the first three fingers of the hand for at least 3 months
排除标准
- •Presence of severe CTS findings on electrophysiological examination
- •Presence of metabolic diseases such as uncontrolled diabetes and hypothyroidism
- •Presence of inflammatory rheumatic disease (e.g., rheumatoid arthritis)
- •Presence of other neuromuscular diseases affecting the hand and wrist (Polyneuropathy, Cervical radiculopathy, peripheral nerve damage, Brachial plexus damage, other entrapment neuropathies, etc.)
- •History of hand and wrist trauma
- •History of neck and wrist surgery
- •History of steroid injection into the carpal tunnel within the last 3 months
- •History of physical therapy application to wrist within the last 3 months
- •Deformity preventing the use of a splint on the wrist
- •Previous participation in a program for the psychological management of chronic pain
- •Cognitive dysfunction preventing cooperation with tests
研究组 & 干预措施
Group 1 (home based exercise program)
Group 1 will receive training on median nerve gliding exercises and self-stretching exercises for the carpal ligament. Patients will be asked to perform 3 sets of median nerve gliding exercises, each consisting of 10 repetitions, and self-stretching exercises for the carpal ligament 3 times a day for 30 seconds as part of home program.
干预措施: Exercise (Other)
Group 2 (home based exercise program and pain neuroscience education)
Group 2 will receive exercise and pain neuroscience education. The exercise will be taught as a home program, similar to the other group. Pain neuroscience training will be provided twice a week for a total of 6 sessions by a trained physical therapist.
干预措施: Exercise (Other)
Group 2 (home based exercise program and pain neuroscience education)
Group 2 will receive exercise and pain neuroscience education. The exercise will be taught as a home program, similar to the other group. Pain neuroscience training will be provided twice a week for a total of 6 sessions by a trained physical therapist.
干预措施: Pain neuroscience education (Behavioral)
结局指标
主要结局
Boston Carpal Tunnel Questionnaire - Functional Status Scale
时间窗: Baseline, in the 3rd week and in the 6th week
Functional Status Scale is an 8-item questionnaire used to assess the functional status of patients with CTS. Each item is scored from 1 to 5. Scores range from 1 (no functional deficit) to 5 (worst possible function). The patient's functional status score is the average of all 8 items.
Boston Carpal Tunnel Questionnaire - Symptom Severity Scale
时间窗: Baseline, in the 3rd week and in the 6th week
Symptom Severity Scale is an 11-item questionnaire used to assess symptom severity in individuals with CTS. Each item is scored from 1 to 5. Scores range from 1 (no symptoms) to 5 (worst symptoms). The patient's symptom severity score is the average score of 11 items.
Numerical Rating Scale
时间窗: Baseline, in the 3rd week and in the 6th week
Patients rate the current pain intensity from 0 ("no pain") to 10 ("worst possible pain").
6-item carpal tunnel syndrome symptom scale (CTS-6)
时间窗: Baseline, in the 3rd week and in the 6th week
6 items are evaluated out of a total of 26 points. If the patient's total score is above 5, the probability of carpal tunnel syndrome is 25%, while if it is above 12, the probability reaches 80%.
Leeds Assessment of Neuropathic Symptoms and Signs (LANSS)
时间窗: Baseline, in the 3rd week and in the 6th week
It consists of a total of 7 items. The scale is scored between 0 and 24, with a score of 12 or higher suggesting neuropathic pain.
次要结局
- Ultrasound median nerve cross-sectional area(Baseline, in the 3rd week and in the 6th week)
- Semmes-Weinstein Monofilament Test(Baseline, in the 3rd week and in the 6th week)
- Two-Point Discrimination Test (2PD)(Baseline, in the 3rd week and in the 6th week)
- Quantitative sensory evaluation(Baseline, in the 3rd week and in the 6th week)
- Hand grip strength measurement(Baseline, in the 3rd week and in the 6th week)
- Finger pinch strength measurement(Baseline, in the 3rd week and in the 6th week)
研究者
MAHMUT TALHA SUSAM
MD
Karamanoğlu Mehmetbey University