Comparison of the Efficacy of Ultrasound-Guided Median Nerve Hydrodissection With Dexamethasone and Dextrose at Different Volumes in Patients With Carpal Tunnel Syndrome: A Prospective, Randomized, Double Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Change in median nerve cross-sectional area values
研究概览
简要总结
The aim of this study is to compare the efficacy of ultrasonography-guided hydrodissection technique with 5% dextrose and dexamethasone injectates when applied in different volumes in the treatment of mild to moderate carpal tunnel syndrome.
详细描述
Carpal tunnel syndrome (CTS) is the most common peripheral nerve entrapment neuropathy worldwide, resulting from the compression of the median nerve in the carpal tunnel, an osteofibrous canal whose roof is formed by the flexor retinaculum and whose floor is formed by the carpal bones. CTS accounts for approximately 90% of all entrapment neuropathies, and an individual's lifetime risk of diagnosis is estimated to be 10%. It is estimated that about 5% of the population suffers from CTS. It is more common in women compared to men and at least half of the cases manifests between the ages of 40 and 60.
In clinical practice, the most common complaints of patients include neuropathic symptoms along the distribution of the median nerve. These complaints, which initially occur and flare up at night and intermittently during the day, may become continuous and worsen in the later stages of the disease.
Taking an accurate history and clinical assessment is crucial for diagnosis. Evaluation of sensory abnormalities, loss of two point discrimination, and the strength of abductor pollicis brevis muscle can provide information about functional impairment. Tinel's sign and Phalen's manoeuvre are some of diagnostic tests. Some scales and questionnaires are used in diagnosis and assessment of functionality. Ultrasonography is a useful, inexpensive and easily accessible method to simultaneously observe morphological changes in the median nerve and scan the surrounding anatomy. Electrophysiological assessment is very sensitive in examining median nerve dysfunction caused by nerve damage. Nerve conduction studies are considered the gold standard method in diagnosis, determining prognosis and making treatment decisions.
The management of CTS in patients depends on the severity of the disease. In mild and moderate circumstances conservative treatments are recommended for the patients. Surgery is typically considered for patients with moderate to severe CTS or individuals who do not experience significant improvement with conservative treatments. Conservative treatments include patient education, wrist splinting, medical treatments, physical therapy, and perineural injections.
Ultrasound-guided nerve hydrodissection injection has emerged as a therapeutic approach with less complications for CTS. This method aims to achieve mechanical release from perineural adhesions by creating a perineural fluid plane.Various injectates such as normal saline, 5% dextrose, and platelet-rich plasma,viscosupplements are commonly used for hydrodissection. Many studies have been conducted with the hypothesis that the injection volume, in addition to the injection preparation, would also be important in median nerve hydrodissection, and different results have been obtained.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
The patient, the administering physician, the physician conducting the clinical and ultrasonographic evaluation, and the physician performing the electrophysiological examination will not be informed about the injection materials assigned to the patients.
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
- •Patients who are 18 years of age or older
- •Patients who are clinically diagnosed with CTS
- •Patients who have mild or moderate CTS confirmed by EMG study
- •Patients unresponsive to 2-weeks of nightly volar wrist splinting
排除标准
- •Patients who are younger than 18 years of age
- •Patients with severe EMG study
- •Presence of thenar atrophy
- •Patients diagnosed with cervical radiculopathy, myelopathy, brachial plexopathy or polyneuropathy
- •Patients diagnosed with thoracic outlet syndrome
- •Patients diagnosed with inflammatory rheumatic disease
- •Patients diagnosed with connective tissue disease
- •Patients diagnosed with neuromuscular disease
- •Patients diagnosed with peripheral vascular disease
- •Patients with history of malignancy
- •Patients who have uncontrolled hypothyroidism, hyperthyroidism or diabetes mellitus
- •Patients diagnosed with chronic renal failure
- •Patients diagnosed with acromegaly
- •Patients with history of surgery and/or fracture at the symptomatic upper extremity
- •Patients with a history of injection into the median nerve lasting less than 6 months at the symptomatic wrist
- •Patients who are pregnant
- •Patients with history of chronic steroid or chronic alcohol use
结局指标
主要结局
Change in median nerve cross-sectional area values
时间窗: Baseline, 2nd week, 4th week, 12th week
The median nerve cross-sectional area value will be measured by ultrasound at the proximal inlet of the carpal tunnel at the level of the os pisiforme and os hamatum.
Change in median motor nerve conduction velocity (MNCV) values from the electrophysiological study
时间窗: Baseline, 12th week
Electrophysiological Study: Sensory and motor nerve conduction studies of both median and ulnar nerve
Change in median sensory nerve conduction velocity (SNCV) values from the electrophysiological study
时间窗: Baseline, 12th week
Electrophysiological Study: Sensory and motor nerve conduction studies of both median and ulnar nerve
Functional and clinical improvement measured by change in Boston Carpal Tunnel Questionnaire (BCTQ)
时间窗: Baseline, 2nd week, 4th week, 12th week
It is a symptom and functionality assessment questionnaire for carpal tunnel syndrome developed by Levine et al. in 1993. It consists of two parts that evaluate symptom severity (Symptom Severity Scale) and functional status (Functional Status Scale). It consists of 11 questions about symptoms and 8 questions about functional status and has 5 possible answers. Each answer is scored between 1-5. The two sections are evaluated separately and the total score obtained. Minimum Symptom Severity Scale score is 11 and maximum score is 55. Minimum Functional Status Scale score is 8 and maximum score is 40. Calculating the total score as 19 (nineteen) indicates no disability, while the highest score of 95 (ninety five) indicates the highest disability. In our study, the investigator will use the Turkish language version of BCTQ, the validity and reliability of which has been demonstrated.
Change in median sensory nerve action potential (SNAP) values from the electrophysiological study
时间窗: Baseline, 12th week
Electrophysiological Study: Sensory and motor nerve conduction studies of both median and ulnar nerve
Change in median sensory nerve latency (SNL) values from the electrophysiological study
时间窗: Baseline, 12th week
Electrophysiological Study: Sensory and motor nerve conduction studies of both median and ulnar nerve
Clinical improvement measured by change in Numeric Rating Scale
时间窗: Baseline, 2nd week, 4th week, 12th week
A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. Scale ranges from '0' representing "no pain" to '10' representing "pain as bad as you can imagine" or "worst pain imaginable". Higher scores related to worse outcome.
Functional and clinical improvement measured by change in Quick- Disabilities of Arm, Shoulder and Hand Questionnaire (Q-DASH) Scores
时间窗: Baseline, 2nd week, 4th week, 12th week
The Q-DASH questionnaire, which is a shortened version of the DASH questionnaire, consists of 11 items to measure physical functions and symptoms of the upper extremity. In order for the Q-DASH score to be calculated, at least 10 of the 11 topics must be answered. All items are scored between 1-5. In this scoring, 1 point indicates not having any difficulty during the activity, while 5 points indicates not being able to do the activity at all. Calculating the total score as 0 (zero) indicates no disability, while the highest score of 100 indicates the highest disability. In our study, the investigator will use the Turkish form of the Q-DASH questionnaire, whose validity and reliability has been demonstrated.
Change in median nerve distal motor latency (DML) values from the electrophysiological study
时间窗: Baseline, 12th week
Electrophysiological Study: Sensory and motor nerve conduction studies of both median and ulnar nerve
Change in median nerve compound muscle action potential (CMAP) values from the electrophysiological study
时间窗: Baseline, 12th week
Electrophysiological Study: Sensory and motor nerve conduction studies of both median and ulnar nerve
Change in 6-item CTS symptoms scale scores
时间窗: Baseline, 2nd week, 4th week, 12th week
It consists of 6 items. A special score was created for each item. The score of each item is calculated by addition. Minimum score is 0 (zero), maximum score is 26 (twenty six). Patients who score 12 points or more in total are highly expected to have CTS.
次要结局
- Change in two point discrimination test values(Baseline, 2nd week, 4th week, 12th week)
- Change in hand grip strength values(Baseline, 2nd week, 4th week, 12th week)
研究者
Sevgi Selin Kurtoglu
Residency doctor
Istanbul University - Cerrahpasa