Pulsed Ultrasound Versus Pulsed Shortwave Diathermy in Mild-to-Moderate Carpal Tunnel Syndrome: A Randomized Controlled Trial
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
- Change in Median Nerve Cross-Sectional Area (MNCSA)
研究概览
简要总结
The goal of this clinical trial is to compare two physical therapy treatments in people with mild-to-moderate carpal tunnel syndrome (CTS). CTS is a condition that causes pain, numbness, and weakness in the hand.
The main question this study aims to answer is:
Does pulsed ultrasound or pulsed shortwave diathermy lead to greater improvement in symptoms and nerve swelling when added to standard treatment?
All participants will receive standard conservative treatment, including a wrist splint and nerve and tendon gliding exercises for three weeks. In addition, participants will be randomly assigned to receive one of the following treatments:
Pulsed therapeutic ultrasound (US) Pulsed shortwave diathermy (SWD) Researchers will measure changes in hand symptoms, pain levels, grip strength, and the size of the median nerve using ultrasound imaging. Assessments will be performed before treatment, and at 1 month and 3 months after treatment.
The primary outcome of the study is the change in median nerve cross-sectional area at 3 months.
详细描述
Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy of the upper extremity and is characterized by pain, numbness, and hand weakness. Conservative treatment is recommended as first-line therapy in patients with mild-to-moderate CTS and commonly includes wrist splinting and nerve and tendon gliding exercises. Physical therapy modalities are frequently added to improve clinical outcomes.
This randomized, assessor-blinded, parallel-group clinical trial was conducted between March 2025 and Sep 2025. Forty participants with electrophysiologically confirmed mild-to-moderate CTS were randomly assigned to one of two intervention groups. All participants received standard conservative treatment consisting of neutral-position wrist splinting and tendon-nerve gliding exercises for three weeks.
In addition to standard treatment, one group received pulsed therapeutic ultrasound (US) and the other group received pulsed shortwave diathermy (SWD), administered in 15 sessions over three weeks.
Outcome measures were assessed at baseline, 1 month, and 3 months. The primary outcome was the change in median nerve cross-sectional area measured by ultrasonography at 3 months. Secondary outcomes included symptom severity and functional status assessed by the Boston Carpal Tunnel Questionnaire (BCTQ), pain intensity measured by the Visual Analog Scale (VAS), neuropathic pain assessed using the DN4 questionnaire, and hand grip strength measured with a dynamometer.
The study was designed to compare the clinical and structural effects of pulsed US and pulsed SWD when added to standard conservative treatment in mild-to-moderate CTS.
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
- Single (Outcomes Assessor)
盲法说明
Outcome assessments, including ultrasonographic measurements and clinical questionnaires, were performed by an assessor blinded to group allocation. Participants and treatment providers were not blinded due to the nature of the interventions.
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
- •Age between 18 and 65 years
- •Symptom duration of at least 4 weeks
- •Diagnosis of mild-to-moderate carpal tunnel syndrome confirmed by electromyography
排除标准
- •Cervical radiculopathy
- •Brachial plexopathy
- •Thoracic outlet syndrome
- •Previous carpal tunnel surgery
- •Severe carpal tunnel syndrome
- •Pregnancy
- •Malignancy
- •Coagulation disorders
- •Cardiac pacemaker
- •Physical therapy for carpal tunnel syndrome within the previous 6 months
研究组 & 干预措施
Short Wave Diathermy Group
Participants in this group received pulsed shortwave diathermy in addition to standard conservative treatment, including wrist splinting and tendon-nerve gliding exercises for three weeks.
干预措施: Pulsed Shortwave Diathermy (Device)
Ultrasound Therapy Group
Participants in this group received pulsed therapeutic ultrasound in addition to standard conservative treatment, including wrist splinting and tendon-nerve gliding exercises for three weeks.
干预措施: Pulsed Therapeutic Ultrasound (Device)
结局指标
主要结局
Change in Median Nerve Cross-Sectional Area (MNCSA)
时间窗: Baseline and 3 months
Change in ultrasonographically measured median nerve cross-sectional area (mm²) from baseline to 3 months after treatment.
次要结局
- Change in Boston Carpal Tunnel Questionnaire Score(Baseline, 1 month, and 3 months)
- Change in Pain Intensity (VAS)(Baseline, 1 month, and 3 months)
- Change in Neuropathic Pain Score (DN4)(Baseline, 1 month, and 3 months)
- Change in Grip Strength(Baseline, 1 month, and 3 months)
研究者
MD.Bilgehan Kolutek Ay
Assistant Professor
Kahramanmaras Sutcu Imam University