Hyperthermia As A Conservative Treatment For Carpal Tunnel Syndrome. A Randomized "Sham" Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Primary outcome is visual analogic scale for pain (VAS)
研究概览
简要总结
The purpose of this study is to verify the short-term effects of hyperthermia (HT) in pain relief and in functional impairment in patients affected by mild to moderate idiopathic carpal tunnel syndrome.
A single blind randomized sham-controlled trial was performed. A 23 patients were affected by idiopathic CTS, 11 of them were affected by bilateral CTS.
the intervention consists of Hyperthermia device treatment, treated for 20 minutes per session, a total of 8 sessions. Primary outcome is pain (Visual analogic scale).
详细描述
Background: Non-surgical treatment is generally administered to patients with mild to moderate symptoms. Many of these treatments used heat modality. Hyperthermia is a relative recent device which produces deep heating.
Objective
The purpose of this study is to verify the short-term effects of hyperthermia (HT) in pain relief and in functional impairment in patients affected by mild to moderate idiopathic carpal tunnel syndrome.
Design: A double blind randomized sham-controlled trial. Setting: Outpatient physical therapy, institutional clinic. Participants: 23 patients were affected by idiopathic CTS, 11 of them were affected by bilateral CTS.
Intervention: Hyperthermia (HT) device treatment, treated for 20 minutes per session, a total of 8 sessions.
Measurement: Primary outcome is pain (Visual analogic scale). Secondary outcomes were self-reported pain intensity and physical functioning questionnaire (Levine/Boston), ultrasonographic (median nerve cross sectional area mnCSA) and neurophysiological data.
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
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bilateral or unilateral mild to moderate carpal tunnel syndrome confirmed by clinical and neurophysiological tests, with no indication to surgical intervention.
- •All patients were grouped into first, second and third classes according to Historic and Objective (Hi-Ob)15 scale of CTS and minimum, mild CTS according to the neurophysiological classification of Padua1
排除标准
- •Secondary entrapment neuropathies (diabetes, systemic disease)
- •Cancer, pregnancy
- •Electroneurographic and clinical signs of axonal degeneration of the median nerve.
结局指标
主要结局
Primary outcome is visual analogic scale for pain (VAS)
时间窗: 4 weeks
次要结局
- Secondary outcomes were self-reported pain intensity and physical functioning questionnaire (Levine/Boston), ultrasonographic (median nerve cross sectional area (mnCSA) and neurophysiological data(4 weeks)