Comparison of the Efficacy of Different Treatment Approaches in Carpal Tunnel Syndrome: Randomized Controlled Double-Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Visuai Analog Scale (VAS)
研究概览
简要总结
The effectiveness of various external applications (strapping and splinting) on grip strength, pain intensity, symptom level, and functional status in carpal tunnel syndrome (CTS) has been compared in this study. Comparative testing was conducted with exercise and mobilization applications (carpal bone mobilization, yoga, tendon and nerve gliding exercises, neurodynamic mobilization, instrument-assisted soft tissue massage, and standard soft tissue massage) in control groups, placebo groups, and groups undergoing other non-surgical treatments (orthotic application, steroid injections, and other physical agents). Criticisms regarding these studies include bias, lack of blinding, and small intergroup differences. In the literature, evidence supporting the beneficial effects of splinting and strapping applications on CTS is reported to be of low quality, emphasizing the need for higher-quality studies. In light of the information obtained, this study aims to compare the effects of different external applications (strapping and splinting) on grip strength, pain intensity, symptom level, and functional status in CTS.
详细描述
The inclusion of 40 volunteers is planned for the study. Participants will be divided into four groups, namely control, splint, rigid strapping, and kinesiotape, with the intention of having 10 participants in each group using the closed envelope method.
In the control group (CG), a conventional physiotherapy program will be implemented for 2 weeks. A 10-session treatment will be completed using thermal and electrical agents specified in the program prescribed by the physiotherapist.
In the Splint (SP) group, in addition to the 10-session conventional physiotherapy program, individuals will be instructed to use the splint prescribed by the physician for 2 weeks.
In the Rigid Strapping (RB) group, along with the 10-session conventional physiotherapy program, a rigid strapping application will be performed by an experienced researcher at the end of each physiotherapy session, five days a week.
In the Kinesiotape (KT) group, in addition to the 10-session conventional physiotherapy program, kinesiotape application will be carried out by a certified researcher. To ensure homogeneity, individuals in both strapping groups will be asked to remove the tape before coming to treatment and reapply it at the end of the session. All participants included in the study will be evaluated twice, before and after treatment.
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 (Participant, Outcomes Assessor)
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
- •To be volunteered
- •To be in the age range of 18-65
- •To be diagnosed with mild to moderate carpal tunnel syndrome (CTS) through median nerve conduction velocity studies
- •To have experienced paresthesia, pain, and vasomotor symptoms in the area associated with the N. medianus for more than six weeks, as determined by studies on median nerve conduction.
- •To test positive in Phalen, Tinel, or carpal compression tests
- •To have been recommended splint therapy for CTS
排除标准
- •Having a distal motor latency of the median nerve of less than 4.2 milliseconds and/or a distal sensory latency of less than 3.2 milliseconds as a result of electrodiagnostic studies on nerve conduction velocity
- •History of malignant tumor
- •Use of a pacemaker
- •Presence of severe electrodiagnostic findings (fibrotic changes in the median nerve)
- •Another inflammatory condition (rheumatoid arthritis, tendinitis, etc.)
- •Osteoarthritis in the hand/wrist
- •Any musculoskeletal conditions affecting the hand, elbow, or wrist
- •Yhyroid dysfunction
- •Diagnosis of chronic kidney failure and undergoing treatment for it
- •History of carpal tunnel surgery, upper extremity, and neck surgery and trauma
- •Diagnosis of carpal tunnel syndrome associated with pregnancy or diabetes
- •Having received any treatment for carpal tunnel syndrome (splint therapy, physical agents, exercise, local corticosteroid injection) up to 3 months before the tests
- •Hypersensitivity (allergy to Kinesiotape or rigid strapping)
结局指标
主要结局
Visuai Analog Scale (VAS)
时间窗: Baseline- after two weeks
Pain
Boston Carpal Tunnel Syndrome Questionnaire
时间窗: Baseline- after two weeks
Symptom and Function
Handgrip Dynamometer
时间窗: Baseline- after two weeks
Grip
次要结局
未报告次要终点
研究者
Banu BAYAR
Professor
Muğla Sıtkı Koçman University