Investigation of the Efficacy of Virtual Reality Mediated Neurodynamic Exercises in Carpal Tunnel Syndrome: A Prospective Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Boston Carpal Tunnel Questionnaire
研究概览
简要总结
Carpal tunnel syndrome (CTS) is the most common nerve entrapment syndrome. It occurs as a result of compression of the median nerve as it passes through a restricted osteofibrous canal in the wrist. Known as the carpal tunnel, this canal contains the wrist bones, transverse carpal ligament, median nerve, and digital flexor tendons. Edema, tendon inflammation, hormonal changes, and manual activity can contribute to increased nerve compression and sometimes cause pain.
In this research, the investigators aim to present the virtual reality-mediated exercise program to patients non-immersive. It is planned to use the Leap Motion motion sensor to detect hand and wrist movements and to monitor the gamified setup on the computer screen.
In the system that will be presented via computer and hand motion sensor, the patient will be asked to perform therapeutic exercises for the diagnosis of CTS in a scenario developed through virtual reality. The investigators predict that patients will actively participate in virtual reality-mediated therapeutic exercise program with high motivation and their functional results will be better than classical exercise programs.
In our research, the investigators aim to present the tendon and nerve gliding exercises with proven effectiveness in patients with CTS, with non-immersive virtual reality systems, and to compare their effectiveness with the classical exercise program.
详细描述
Carpal tunnel syndrome (CTS) is the most common nerve entrapment syndrome. It occurs as a result of compression of the median nerve as it passes through a restricted osteofibrous canal in the wrist. Known as the carpal tunnel, this canal contains the wrist bones, transverse carpal ligament, median nerve, and digital flexor tendons. Edema, tendon inflammation, hormonal changes, and manual activity can contribute to increased nerve compression and sometimes cause pain. In more severe cases, weakness may occur in the muscles innervated by the median nerve, resulting in weakness in hand muscle strength(1). In a comprehensive study, the mean age for the diagnosis of CTS was found to be 50 years, and its prevalence was found to be similar in men and women. However, the prevalence was higher in women; The incidence in women aged 65-74 was found to be four times higher than in men(2).
Many different treatment methods are used in the treatment of CTS, and these treatments include regulation of daily activities, use of splints, tendon and nerve gliding exercises, ESWT, manual therapy, kinesiotaping, physical therapy agents, medical symptomatic treatments, injections into the carpal tunnel and surgical treatment options. .
Suspected risk factors for CTS include diabetes mellitus, menopause, hypothyroidism, obesity, arthritis, and pregnancy. Since hypothyroidism, menopause, and pregnancy are risk factors, there is a strong suspicion that hormonal changes may play a role in the etiology of CTS; however, no evidence was found to support this hypothesis.
In the diagnosis of CTS, a comprehensive and accurate clinical history should be taken together with the exclusion of other possible causes. The syndrome is characterized by intermittent and then increasing nocturnal paresthesia and dysesthesia findings. Later, sensory loss develops with hand muscle weakness and muscle atrophy of the thenar region, resulting from extensive axonal degeneration in the course of the disease. This set of symptoms is quite typical and rarely occurs in disorders other than CTS. In severe CTS cases, paresthesia symptoms may spread to the proximal forearm and upper arm, and sometimes to the shoulder(3).
In the following periods, loss of strength and atrophy of the thenar region muscles may occur. The diagnosis is made by clinical examination, electrophysiological methods (EMG) and imaging methods (such as ultrasound, magnetic resonance imaging). The clinical examination consists of sensory-motor examination and provocative tests. 1-2-3 on sensory examination. numbness with touch (paresthesia) or low sense of touch (hypoesthesia) in the fingers are detected. Motor examination may be normal in the early stage, and later on, weakness (weakness) in the thumb abducting and opposing muscle is detected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The researcher evaluating the participants will be blind to the group distributions.
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
- •Having an EMG of the last 1 year and a diagnosis of mild and moderate CTS in this EMG,
- •Between the ages of 20-70,
- •Using a resting splint for the diagnosis of CTS,
- •It was determined that he agreed to participate in the exercise program and to stop other therapeutic interventions to be applied to the wrist during the 3-month follow-up period.
排除标准
- •Having a history of Cervical Radiculopathy,
- •Having a diagnosis of rheumatoid arthritis,
- •Having a history of acute trauma,
- •Steroid injection to the wrist in the last 3 months,
- •Having undergone wrist surgery in the last 3 months,
- •Having an open wound around the wrist,
- •Presence of uncontrolled disease (endocrinological, cardiovascular, pulmonary, hematological, hepatic, renal) was determined as patients with a history of active systemic inflammatory disease and/or malignancy.
研究组 & 干预措施
Virtual Reality Group
Tendon and nerve gliding exercises will be applied to the patients in the virtual reality group for 2 weeks, for a total of 10 sessions, through the developed software. Patients will be asked to come for 2 weeks for the virtual reality mediated exercise program. Patients will be asked to do their exercises in a virtual reality-mediated exercise protocol, with 1 session of approximately 30 minutes. Apart from the exercise program, patients will be asked to use wrist splints.
干预措施: Wrist Splint (Other)
Virtual Reality Group
Tendon and nerve gliding exercises will be applied to the patients in the virtual reality group for 2 weeks, for a total of 10 sessions, through the developed software. Patients will be asked to come for 2 weeks for the virtual reality mediated exercise program. Patients will be asked to do their exercises in a virtual reality-mediated exercise protocol, with 1 session of approximately 30 minutes. Apart from the exercise program, patients will be asked to use wrist splints.
干预措施: Virtual Reality Mediated Exercise (Other)
Conventional Exercise Group
For the patients in the classical exercise group; The classical exercise program will be taught in the company of a physiotherapist and they will be asked to do these exercises for a total of 10 sessions for 2 weeks. The patients' home exercise programs will be controlled by weekly phone calls. Apart from the exercise program, patients will be asked to use wrist splints.
干预措施: Exercise (Other)
Conventional Exercise Group
For the patients in the classical exercise group; The classical exercise program will be taught in the company of a physiotherapist and they will be asked to do these exercises for a total of 10 sessions for 2 weeks. The patients' home exercise programs will be controlled by weekly phone calls. Apart from the exercise program, patients will be asked to use wrist splints.
干预措施: Wrist Splint (Other)
Control Group
Patients in the control group will be advised to continue using splints. It will be evaluated by repeated examinations.
干预措施: Wrist Splint (Other)
结局指标
主要结局
Boston Carpal Tunnel Questionnaire
时间窗: Change in this scale will be evaluated before the intervention, 1 month, and 3 months after the intervention.
It is used to assess symptom severity and functional capacity in CTS. This scale is scored between 19-95 points, with higher scores indicating worse results.
Nerve conduction study
时间窗: Change in this scale will be evaluated before the intervention, 1 month, and 3 months after the intervention
It will be done to evaluate the involvement of the median nerve from CTS.
Median nerve area
时间窗: Change in this scale will be evaluated before the intervention, 1 month, and 3 months after the intervention
The median nerve area will be measured by ultrasound.
Visual Analog Scale
时间窗: Change in this scale will be evaluated before the intervention, 1 month, and 3 months after the intervention
Pain status will be evaluated with visual analog scale. This scale is scored between 0-10 points, with higher scores indicating worse results.
Hand grip strength
时间窗: Change in this scale will be evaluated before the intervention, 1 month, and 3 months after the intervention
The hand grip and pinch strength of the patients will be evaluated with a dynamometer.
次要结局
未报告次要终点
研究者
Ahmet Kivanc Menekseoglu
Principal Investigator
Istanbul University
