A Comparative Evaluation of the Effectiveness of Kinesiotaping and Peloidotherapy in Patients With Idiopathic Carpal Tunnel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- VAS pain
研究概览
简要总结
Patients diagnosed with mild and moderate idiopathic CTS will be randomly divided into three groups. Patients who received 15 sessions of peloid therapy along with a home exercise program will constitute the first group. The second group will consist of patients who received a total of 6 sessions of kinesiotaping twice a week along with a home exercise program. Patients who were given only a home exercise program will be included in the third group. "Patients will be evaluated in detail in terms of clinical examination and outcomes three weeks after the end of treatment and again at three months.
详细描述
Carpal tunnel syndrome (CTS) is the most common compression neuropathy caused by entrapment of the median nerve in the carpal tunnel. There are 2 methods for the treatment of CTS: conservative and surgical. Conservative treatment is mostly applied in patients with mild and moderate CTS. In this study, the investigators aim to evaluate the efficacy of peloid therapy and kinesiobanding technique, which are conservative treatment methods. Patients will be evaluated in terms of pain, functional/symptom status, hand-finger strength, median nerve ultrasonography measurements.
Patients who were evaluated by detailed clinical examination and medical history according to the inclusion and exclusion criteria were given written informed consent and assigned to one of the three treatment groups using block randomization. Basic sociodemographic information (age, gender, body mass index, employment status, education level, marital status,etc) and clinical data (dominant hand, duration of symptoms, comorbidities, hand to be treated, Tinel/Phalen sign, pain intensity, baseline electrophysiological parameters) will be recorded. The first group will consist of patients who have received peloid therapy at 45 degrees for a total of 15 sessions of 20 minutes, 5 days a week for 3 weeks with a home-based exercise program. The second group will consist of patients who received a home-based exercise program with kinesiotaping for a total of 6 sessions 2 times a week. Patients who only received home-based exercise program will be included in the 3rd group. During the treatment period, patients will be allowed to take only paracetamol for pain, if necessary, except for the medications they use continuously for comorbid reasons.
All groups were evaluated by a blinded assessor based on examination findings (Tinel/Phalen tests), pain intensity (VAS), hand grip strength (HGS), finger pinch strength (FGS), the Turkish version of the Boston Carpal Tunnel Questionnaire, the 4-Question Neuropathic Pain Questionnaire (DN4), and ultrasound measurements (median nerve cross-sectional areas [CSA]) at the proximal insertion of the carpal tunnel (at the level of the scaphoid and pisiform bones and the distal wrist crease), both after treatment (three weeks/W3) and at three months post-treatment (W12).
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Months 至 65 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being between the ages of 18-65
- •Agreeing to participate voluntarily in the study
- •Being diagnosed with mild or moderate idiopathic chronic CTS as a result of anamnesis, clinical examination and nerve conduction study
排除标准
- •Presence of predisposing etiological factors for CTS such as diabetes mellitus, chronic kidney and liver disease, acromegaly, rheumatological diseases, acute trauma, hypothyroidism, etc.
- •Being diagnosed with severe CTS
- •Having a history of previous wrist surgery or trauma
- •Having atrophy in the thenar region or weakness in the thenar muscles
- •Having cervical radiculopathy, thoracic outlet syndrome, polyneuropathy, brachial neuropathy or proximal median nerve neuropathy
- •Having had steroid injections in the last 3 months and taking oral steroid medications
- •Being pregnant
- •Having an open wound or rash in the wrist and its surroundings that would prevent treatment
- •Patients who are receiving or will receive another/additional treatment for CTS
- •Patients with a bifid median nerve, persistent median artery, ganglion cyst, tenosynovitis, or tendinitis in the wrist.
研究组 & 干预措施
Kinesiotaping
This group will be given a home exercise program along with a total of 6 sessions of kinesiotaping twice a week.
干预措施: Kinesiotaping (Other)
Kinesiotaping
This group will be given a home exercise program along with a total of 6 sessions of kinesiotaping twice a week.
干预措施: Home exercise (Other)
Peloidotherapy
This group will consist of patients who have received peloid therapy for a total of 15 sessions of 20 minutes at 45 degrees for 3 weeks, 5 days a week, along with a home exercise program.
干预措施: Peloidotherapy (Other)
Peloidotherapy
This group will consist of patients who have received peloid therapy for a total of 15 sessions of 20 minutes at 45 degrees for 3 weeks, 5 days a week, along with a home exercise program.
干预措施: Home exercise (Other)
Home exercise
This group will consist of patients who have only been given a home exercise program. Flexor tendon gliding exercises, median nerve gliding exercises, and isometric wrist strengthening exercises will be given as exercises.
干预措施: Home exercise (Other)
结局指标
主要结局
VAS pain
时间窗: baseline, week 3 and week 12
A 10 cm long line is drawn, this line is divided into 10 intervals of 10 mm width, 0: no pain and 10: the most severe pain is explained, and the patient is asked to mark the value corresponding to the resting pain and the pain during movement on the scale.
The Boston Carpal Tunnel Syndrome Questionnaire
时间窗: baseline, week 3 and week 12
The Turkish version of the Boston Carpal Tunnel Questionnaire score. It is used to evaluate the symptom severity and functionality of the patients. BCTQ is a questionnaire consisting of 2 parts: symptom severity scale (SSS) and functional status scale (FSS). Each item in both sections has 5 different answers that score between 1 and 5. The mean score is obtained by dividing the total score by the number of questions and ranges from 1 to 5, with a higher score indicating severe symptom.
次要结局
- Finger pinch strength(baseline, week 3 and week 12)
- Hand grip strength(baseline, week 3 and week 12)
- Ultrasonographic evaluation of the median nerve(baseline, week 3 and week 12)
- Douleur Neuropathique 4(baseline, week 3 and week 12)
研究者
Ayşe Güleç
MD
Konya Beyhekim Training and Research Hospital