Comparison of Initial Treatment for Carpal Tunnel Syndrome Related to Rheumatic Diseases: Corticosteroid Injection Versus Nighttime Splinting

Официальное название

Comparison of Initial Treatment for Carpal Tunnel Syndrome Related to Rheumatic Diseases: Corticosteroid Injection Versus Nighttime Splinting - A Pragmatic, Open-Label, Multicenter, Randomized Clinical Trial

Обзор

The aim of this study is to evaluate the effects of corticosteroid injection verses nighttime splinting as initial treatments on wrist function, quality of life, and sleep quality in patients with rheumatoid disease-related carpal tunnel syndrome. Participants will be randomly assigned to two groups and will receive the following interventions: one group will wear a neutral position night splint for 6 weeks, and the other group will receive a single local injection of methylprednisolone 40 mg as the initial treatment. Follow-up evaluations will be conducted at 6, 12, and 18 weeks to assess wrist function, sleep quality, and quality of life, and to dynamically adjust the treatment plan.

Вмешательства

• Устройство Nighttime Splinting
  Nighttime splinting for 6 weeks.
• Препарат Corticosteroid Injection
  Local corticosteroid injection (triamcinolone acetonide 40mg). A single injection of triamcinolone acetonide 40mg mixed with an equal volume of 1% lidocaine is administered. The injection is performed under ultrasound guidance and anatomical landmarks to target the proximal carpal tunnel. With the wrist extended, the needle is typically inserted on the ulnar side of the palmaris longus tendon, approximately 1 cm proximal to the wrist crease. If blood is aspirated or the patient reports paresthes
• Другое Evaluation and Dynamic Adjustment
  6 weeks later, all patients will undergo evaluation of their initial treatment. Further therapeutic decisions will be made based on physician assessment, including: continuing nighttime splinting, administering corticosteroid injections to patients who initially received only the splint, adding nighttime splinting for patients initially received only corticosteroid injections, and transitioning from nighttime splint use to continuous wear. Subsequently, evaluations will be conducted every 6 week

Первичные конечные точки

• Change from baseline in BCTQ function status subscale at 6 weeks [Срок оценки: 0,6 weeks]
• Change from baseline in BCTQ symptom severity subscale at 6 weeks [Срок оценки: 0,6 weeks]

Вторичные конечные точки (6)

• Change from baseline in BCTQ symptom severity subscale [Срок оценки: 0,12,18 weeks]
• Change from baseline in BCTQ function status subscale [Срок оценки: 0,12,18 weeks]
• Change from baseline of EQ-VAS [Срок оценки: 0,6,12,18 weeks]
• Change from baseline of PSQI [Срок оценки: 0,6,12,18 weeks]
• Change from baseline of the cross-sectional area of the median nerve [Срок оценки: 0,18 weeks]
• Surgical rate within 18 weeks [Срок оценки: 18 weeks]

Критерии участия

Критерии включения

• Patients aged no less than 18 years old with unilateral or bilateral carpal tunnel syndrome diagnosed by a specialist according to the Katz diagnostic criteria, and with at least one associated rheumatic disease;
• Patients have had symptoms of CTS for at least six weeks, and the side with more severe symptoms is designated as the target side for the study.
• During the current episode, the target side has not been treated.

Критерии исключения

• Patients who have plan for surgical treatment on his or her CTS within the following 6 months;
• Received corticosteroid injections in the wrist within the past 6 months;
• Patients who are unable to wear a splint due to trauma or other reasons;
• Patients with clinical manifestations or electrophysiological changes indicative of significant axonal loss or denervation, including thenar muscle atrophy, sensory loss (two-point discrimination greater than 8 mm), absence of SNAP (sensory nerve action potential), absence of CMAP (compound muscle action potential) in the thenar muscles, etc.;
• Patients who require long-term use of any form of opioids.
• Patients who have used opioids (e.g., tramadol) or neuropathic pain medications (gabapentin, pregabalin, etc.) within the past 2 weeks;
• Patients who have received non-recommended wrist injection treatments (e.g., 5% glucose, platelet-rich plasma, ozone, chitosan, hyaluronic acid, etc.) within the past 6 months;
• Patients who have undergone non-recommended physical therapies (e.g., electrotherapy, magnetotherapy, laser therapy, etc.) within the past 6 months;
• Patients who are pregnant or plan to become pregnant within the next 6 months.

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

Открытое

Основная цель

Лечение

Центры проведения

Китай · 3 центра

• Jinjiang Municipal Hospital(Shanghai Sixth People's Hospital Fujian Campus) — Jinjiang
• Yancheng Third People's Hospital — Yancheng
• Shanghai Sixth People's Hospital — Шанхай

Идентификаторы

NCT: NCT07042282 · 2025-KY-096

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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