Comparison of the Effects of Rest Splints and High-Intensity Laser Therapy on Pain, Function, Nerve Conduction Studies, and Grip Strength in Patients With Carpal Tunnel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Visual Analog Scale (VAS):
研究概览
简要总结
The aim of this study is to compare the effectiveness of rest splints and high-intensity laser therapy(HILT) added to physical therapy programs for patients with carpal tunnel syndrome in terms of pain, function, nerve conduction studies, and grip strength.
详细描述
Carpal tunnel syndrome (CTS) is the most common entrapment nerve compression, causing numbness and tingling in the hand, atrophy and muscle weakness in advanced stages. Any condition that increases the volume of the carpal tunnel and narrows the diameter of the tunnel can increase the compression of the median nerve under the transverse carpal ligament and cause symptoms. The use of a wrist splint or wrist brace is a common method of non-surgical treatment of carpal tunnel syndrome. The wrist splint is designed to allow rotation and supination, while eliminating the possibility of extension, flexion and radial-ulnar deviation.High-intensity laser therapy is used to provide symptomatic relief and reduce pain-related inflammation. The soothing effect of the laser is remarkable, especially in acute cases, but in the case of chronic disorders, the pain may be aggravated after the first treatments and is continued only if it decreases.
This study was designed as a prospective randomised controlled trial. Participants were randomised into 3 groups. The 1st group will receive wrist range of motion exercises, isometric strengthening, intrinsic muscle strengthening, wrist stretching, desensitization exercises, tendon sliding exercises, median nerve sliding exercises, wrist flexion and extension exercises, grip strengthening exercises and resting splint application for 6 weeks, 5 days a week, 30 sessions in total. The 2nd group (HILT group) will be given high intensity laser therapy 5 days a week for 6 weeks (30 sessions in total) in addition to the physical therapy program. The 3rd group will be the sham HILT group and physical therapy exercises will be applied like the other groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-75 years who have been diagnosed with carpal tunnel syndrome based on their medical history, physical examination, clinical findings, and electromyography(EMG) results, who have applied to the outpatient clinic for physical therapy, and who have no contraindications for treatment will be included in the study after obtaining their consent.
排除标准
- •Diabetes Mellitus
- •Hypothyroidism
- •Acromegaly
- •Rheumatic Diseases
- •Polyneuropathy
- •Ipsilateral brachial plexopathy and traumatic nerve injury in the upper extremity
- •Previous injection into the carpal tunnel within the last 6 months and physical therapy
- •Pregnancy
- •History of malignant tumors
- •Patients with cochlear implants
- •Acquired Immunodeficiency Syndrome
- •History of neck and/or shoulder surgery
- •Corticosteroid consumption, analgesic medication use
- •Skin lesion
研究组 & 干预措施
Experimental: 1. Group (rest splint group)
The physical therapy program we routinely provide to patients with carpal tunnel syndrome in our physical therapy unit (wrist ROM isometric strengthening, intrinsic muscle strengthening, wrist stretching, desensitization exercises, tendon gliding exercises, median nerve gliding exercises, wrist flexion and extension exercises, grip strengthening exercises) will be provided to patients with carpal tunnel syndrome in our physical therapy unit. Patients will be instructed to use a splint for rest as much as possible during the day and for as long as possible at night for a period of 6 weeks.
干预措施: Rest splint group (Device)
Experimental: Group 2 (high-intensity laser therapy (HILT))
This group will receive high-intensity laser therapy applied over the carpal tunnel region. HILT delivers deep tissue photothermal and photomechanical effects, promoting tissue repair and reducing inflammation. The treatment is expected to decrease pain and improve nerve conduction and grip strength.
干预措施: high-intensity laser therapy (HILT) (Device)
Sham Comparator: Group 3 (sham high-intensity laser therapy (HILT) )
Participants in this group will undergo a placebo laser treatment using the same device without active laser emission. The procedure will mimic the real HILT application to ensure blinding. This group will help distinguish the true therapeutic effects of HILT from placebo responses.
干预措施: sham high-intensity laser therapy (HILT) (Device)
结局指标
主要结局
Visual Analog Scale (VAS):
时间窗: Baseline(pre-treatment,after 6 weeks(post treatment)-after 12 weeks(post treatment)
Patients' musculoskeletal pain intensity was assessed using the visual analog scale (VAS). The meanings of the numbers placed on a 10 cm line from 0 to 10 were explained to the patients. It was explained that no pain was 0, the most severe pain ever experienced was 10, and moderate pain was 5 points. Based on these explanations, patients were asked to rate their pain levels for the past week.
次要结局
- Boston Carpal Tunnel Questionnaire:(Baseline(pre-treatment,after 6 weeks(post treatment)-after 12 weeks(post treatment))
- LANSS neuropathic pain assessment scale(Baseline(pre-treatment,after 6 weeks(post treatment)-after 12 weeks(post treatment))
- Quick DASH Questionnaire(Baseline(pre-treatment,after 6 weeks(post treatment)-after 12 weeks(post treatment))
- Median nerve compound muscle action potential amplitude (CMAP)(Baseline(pre-treatment,after 6 weeks(post treatment)-after 12 weeks(post treatment))
- Motor nerve conduction velocity(Baseline(pre-treatment,after 6 weeks(post treatment)-after 12 weeks(post treatment))
- Median nerve distal sensory latency(Baseline(pre-treatment,after 6 weeks(post treatment)-after 12 weeks(post treatment))
- Pinchmeter(Baseline(pre-treatment,after 6 weeks(post treatment)-after 12 weeks(post treatment))
- Pittsburgh Sleep Quality Index (PSQI)(Baseline(pre-treatment,after 6 weeks(post treatment)-after 12 weeks(post treatment))
- Median nerve distal motor latency(Baseline(pre-treatment,after 6 weeks(post treatment)-after 12 weeks(post treatment))
- Second finger sensory nerve action potential amplitude(Baseline(pre-treatment,after 6 weeks(post treatment)-after 12 weeks(post treatment))
- )Sensory nerve conduction velocity(Baseline(pre-treatment,after 6 weeks(post treatment)-after 12 weeks(post treatment))
- Grip strength(Baseline(pre-treatment,after 6 weeks(post treatment)-after 12 weeks(post treatment))
研究者
Ramazan Tuncer
med.doctor
Afyonkarahisar Health Sciences University