Effectiveness of a Multimodal Telerehabilitation Program Combining Pain Neuroscience Education and Therapeutic Exercise for Patients With 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
- 30
- 试验地点
- 1
- 主要终点
- Change from Baseline Tampa Scale for Kinesiophobia-11 (TSK-11) at 6 and 12 weeks
研究概览
简要总结
Carpal tunnel syndrome (CTS) is a compressive peripheral neuropathy characterized by pain, tingling sensation and paresthesia in the territory of the median nerve. These symptoms cause significant functional impairment that affects patients' quality of life. Pain neuroscience education (PNE) combined with therapeutic exercise (TE) has shown good results in patients with chronic pain, but the effects of this multimodal treatment via telerehabilitation have not been studied in patients with CTS. Telerehabilitation has demonstrated clinical and functional outcomes as effective as face-to-face interventions, being a good alternative to improve accessibility to rehabilitation care in a context of pandemic and social distancing. The purpose of this study is to provide coordinated, patient-centered care by implementing a Telerehabilitation model for patients with severe CTS. The objective of this study was to compare the effectiveness of a multimodal therapy program (TE plus PNE) versus a unimodal treatment (TE) in patients with CTS.
A Randomized Controlled Trial, simple-blind and multicenter study will be conducted. Patients will be randomly assigned to the multimodal treatment group (TE plus PNE) or to the unimodal treatment group (TE). At admission, an investigator blinded to treatment assignment will conduct data collection. The measurements will be the following outcomes: a) Pain Catastrophizing Scale; b) Tampa Scale for Kinesiophobia-11; c) Numerical Rating Scale (NRS); d) Boston Carpal Tunnel Questionnaire; e) Hospital Anxiety and Depression Scale; f) Quality of Life, using the EQ-5D instrument; g) Patient's global impression of change; h) Katz Diagram; These evaluations will be performed again at week 6 and 12.
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
The investigator at each center responsible for conducting the study evaluations will be blinded to group assignment. A second investigator will be responsible for generating randomization, sequencing, enrolling participants, and assigning participants to treatment. Patients will be blinded to the assigned group
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 20 years of age, severe CTS medical diagnosis, duration of symptoms for more than three months, access to a smartphone with internet, and acceptance to participate in the study.
排除标准
- •Inability to understand instructions, non-controlled mental health pathology, cognitive problems and previous surgery in the upper limb.
结局指标
主要结局
Change from Baseline Tampa Scale for Kinesiophobia-11 (TSK-11) at 6 and 12 weeks
时间窗: Baseline (0 weeks), 6 weeks and 12 week
Kinesiophobia will be evaluated by Tampa Scale for Kinesiophobia (TSK-11SV) (Spanish adaptation. Gómez-Pérez, López-Martínez y Ruiz-Párraga, 2011). Scoring: Items are summed, with a total score from 11-44 and higher values represent a worse outcome (more pain interference in behavior).
Change from Baseline Numerical rating scale (NRS) at 6 and 12 weeks
时间窗: Baseline (0 weeks), 6 weeks and 12 week
The patient must rate his or her pain on a defined scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.
Change from Baseline Pain Catastrophizing Scale (PCS) at 6 and 12 weeks
时间窗: Baseline (0 weeks), 6 weeks and 12 week
To assess catastrophic thinking as a response to pain through 13 statements with 4 possible options from 1 "not at all" to 4 "all the time". a higher score indicates a higher catastrophic thinking
次要结局
- Change from Baseline Hospital Anxiety and Depression Scale (HAD) at 6 and 12 weeks(Baseline (0 weeks), 6 weeks and 12 week)
- Change from Baseline EQ-5D at 6 and 12 weeks(Baseline (0 weeks), 6 weeks and 12 week)
- Change from Baseline Boston Carpal Tunnel Questionnaire (BCTQ) at 6 and 12 weeks(Baseline (0 weeks), 6 weeks and 12 week)
- Change from Baseline Muscular endurance at 6 and 12 weeks(Baseline (0 weeks), 6 weeks and 12 week)
- Hand diagrams(Baseline (0 weeks))
- Patient Global Impression of Change Scale (PGICS)(12 weeks)
研究者
Rodrigo Ignacio Nunez Cortes
Principal Investigator
Hospital Clínico La Florida