Clinical Efficiency Testing of Extracorporeal Radial and Focused Shock Wave Therapy in Patients With Mild to Moderate Carpal Tunnel Syndrome

Официальное название

Efficacy of Radial and Focused Extracorporeal Shockwave Therapy in Patients Wirh Carpal Tunnel Syndrom. a Multicentric, Randomised Observer-blinded Trial

Обзор

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.

Вмешательства

• Устройство radial shock wave therapy
  treatment of the nervus medianus on the level of the carpal tunnel with radial shock wave therapy with 1500 impulses, 5 Hz and 1,5 bar
• Устройство focused shock wave therapy
  treatment of the nervus medianus on the level of the carpal tunnel with focused shock wave therapy with 1500 impulses, 5 Hz and 0,05 mJ/mm²

Первичные конечные точки

• Numeric Rating Scale [Срок оценки: from enrollment until 32 weeks after first shockwave session]
• Boston Carpal Tunnel Questionnaire [Срок оценки: from enrollment until 32 weeks after first shockwave session]

Вторичные конечные точки (3)

• Nerve conduction study parameters [Срок оценки: from enrollment until 32 weeks after first shockwave session]
• Neurosonography of median nerve [Срок оценки: from enrollment until 32 weeks after first shockwave session]
• Nerve conduction study parameters [Срок оценки: from enrollment until 32 weeks after first shockwave session]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06912893 · GS3-EK-1/222-2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗