Efficacy of Radial and Focused Extracorporeal Shockwave Therapy in Patients Wirh Carpal Tunnel Syndrom. a Multicentric, Randomised Observer-blinded Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Numeric Rating Scale
研究概览
简要总结
The aim of the project is to test the efficacy of extracorporeal shock wave therapy (radial + focused) on clinical outcomes in patients with carpal tunnel syndrome (CTS). Shock wave therapy has already been shown to be potentially effective in the literature. However, no studies are known to date that test both shock wave types in one protocol, and the follow-up period in the previous studies was set at a maximum of 24 weeks.
Consequently, this study is planned as a multicenter, prospective, randomized, investigator-blinded study. 60 subjects will be assigned to the two shock wave types, and the follow-up period is scheduled for 32 weeks.
The study will be conducted at the Institute for Physical Medicine and Rehabilitation at the University Hospital Krems and St. Pölten. Recruitment will take place through the respective CTS outpatient clinics of the departments, as well as through private practice (orthopedists, general practitioners, neurologists, etc.). The inclusion and exclusion criteria are checked before the subject is included in the study, with nerve conduction velocity (NCV) being emphasized as a diagnostic method.
After the patient is included in the study or signs the consent form, the relevant demographic, medical, and personal data are collected (pseudonymized procedure). Study-related measurements are then performed (nerve sonography, Boston Carpal Tunnel Questionnaire, Visual Analog Scale). The baseline examinations and follow-up examinations are each performed by the same physician (blinded), while the subsequent shock wave therapy is performed by a second physician.
After the baseline examinations, the patient is randomly assigned to one of the two shock wave groups and receives five shock wave therapy sessions one week apart. The pulses and frequency of both treatments are identical (2000 and 5 Hz, respectively). The intensity is xx bar in the radial group and 0.05 mj/mm² in the focused group.
Detailed follow-up assessments, including all baseline measurements, will be conducted 16 and 32 weeks after the first shock wave therapy. At weeks 8 and 24, a questionnaire (Boston Carpal Tunnel Questionnaire; VAS) will also be sent to the patient.
Patients with bilateral clinical CTS will serve as the control group. In this case, the more symptomatic hand will be assigned to a shock wave treatment group, while the other hand will serve as a control. This means no treatment, but all measurements will be performed in the same way as in the study groups.
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 (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of all genders
- •aged above 18 years
- •suffering from mild to moderate carpal tunnel syndrome with typical symptoms like pain, paresthesia, or fine motoric disorders:
- •very mild (grade 1): sensory nerve conduction velocity mildly reduced orslowercompared to the contralateral side.
- •mild (grade 2): distal motor latency <4,5ms and sensory nerve conduction velocity < 40 m/s
- •moderate (grade 3): distal motor latency between 4,5 and 6,5 ms and preserved sensory nerve amplitude.
- •Patients with bilateral CTS also will be included, whereas the less symptomatic hand will be assessed as well, but receive no therapy.
排除标准
- •Patients with severe CTS (distal motor latency above 6,5ms or absent sensory potentials);
- •Prior therapy (even night splints) for CTS within the last six months
- •The presence of common systemic diseases, that have known influence on the peripheral nerve system, like diabetes mellitus, polyneuropathy orabusive C2 consumption
- •Postsurgical CTS
- •Patients with serious injury of the wrist in medical history (e.g. radius fracture) or previous damage to median nerve and more proximal located compression syndrome of median nerve
- •Patients with implanted electronic devices like defibrillators or pacemakers
- •Pregnant women
- •bifid median nerve;
研究组 & 干预措施
focused shockwave therapy
this arm includes 30 patients with mild to moderate carpal tunnel syndrom who will receive therapy with focused shockwave therapy
干预措施: focused shock wave therapy (Device)
radial shockwave therapy
this arm includes 30 patients with mild to moderate carpal tunnel syndrom who will receive therapy with radial shockwave therapy
干预措施: radial shock wave therapy (Device)
结局指标
主要结局
Numeric Rating Scale
时间窗: from enrollment until 32 weeks after first shockwave session
The patient will be asked to categorize his pain and paresthesia on a numeric scale between 0 and 10.
Boston Carpal Tunnel Questionnaire
时间窗: from enrollment until 32 weeks after first shockwave session
Questionnaire to evaluate symptoms and functional restriction in daily activities in patients with CTS
次要结局
- Nerve conduction study parameters(from enrollment until 32 weeks after first shockwave session)
- Neurosonography of median nerve(from enrollment until 32 weeks after first shockwave session)
研究者
Dr. Constantin Dolle
Dr. med. univ.
University Hospital St. Polten