Radiotherapy Compared to Corticosteroid Injection for Treatment of Hand Osteoarthritis

Официальное название

Low-Dose Radiotherapy Compared to Corticosteroid Injection for Treatment of Hand Osteoarthritis

Обзор

The purpose of this research is to compare low-dose radiotherapy to corticosteroid injection for treatment of hand/wrist osteoarthritis.

Вмешательства

• Препарат Corticosteroid injection (CSI)
  A maximum of 3 joints will be treated with standard a standard combination of methylprednisolone and lidocaine: * 1st Carpometacarpal (CMC) joint - 20 mg methylprednisolone/0.5 mL 1% lidocaine\* * Radiocarpal (RC) joint - 40 mg methylprednisolone/1 mL 1% lidocaine\* * Scaphotrapeziotrapezoidal (STT) joint - 20 mg methylprednisolone/0.5 mL 1% lidocaine\* * Metacarpophalangeal (MCP) joint - 20 mg methylprednisolone/0.5 mL 1% lidocaine * Interphalangeal (IP) joint - 10 mg methylprednisolone/0.25 m
• Лучевая терапия Low-dose radiotherapy (LDRT)
  Subjects will be treated with low-dose radiotherapy of 300cGy in 6 fractions, 2-3 times per week on non-consecutive days. Non-responders to the initial LDRT treatment will receive a second treatment course of 300cGy in 6 fractions to be given 2-3 times per week on non-consecutive days.

Первичные конечные точки

• Change in Visual Analog Scale (VAS) score [Срок оценки: Baseline, monthly for 6 months post-intervention, 9 months post-intervention, 12 months post-intervention]

Вторичные конечные точки (3)

• Change in Cochin Hand Function Scale scores [Срок оценки: Baseline, monthly for 6 months post-intervention, 9 months post-intervention, 12 months post-intervention]
• Change in analgesic medication use [Срок оценки: Baseline, monthly for 6 months post-intervention, 9 months post-intervention, 12 months post-intervention]
• Patient experience, as measured by Was It Worth It questionnaire [Срок оценки: 6 months and 12 months post-intervention]

Критерии участия

Критерии включения

• Patient at Mayo Clinic, Rochester, MN
• Age 50 years or older
• Mild, moderate, or severe hand OA (Kellgren and Lawrence classification grade 2, 3, or 4) on hand radiographs within the last 24 months
• Hand OA pain with a minimum VAS score relating to hand pain of ≥40 (on a 100-point scale) when using the affected hand
• Ability to complete study questionnaires

Критерии исключения

• History of previous surgery to the affected hand(s)
• Autoimmune joint disease such as rheumatoid arthritis or psoriatic arthritis
• Active confounding hand condition such as stenosing tenosynovitis or Dupuytren's contracture
• Recent injury (within last 1 month) to the affected hand causing current pain
• History of crystalline arthritis (gout or pseudogout) flare in the affected hand(s)
• Active use of opioid pain medication(s) or oral steroids within the last 3 months
• Fibromyalgia or central sensitization syndrome
• Hand CSI or other hand injection within the past 3 months
• History of hand LDRT within the past 3 months
• Poorly controlled diabetes (HbA1c > 10%)
• Active infection
• Current pregnancy

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

США · 1 центр

• Mayo Clinic in Rochester — Rochester

Идентификаторы

NCT: NCT07217405 · 24-010252

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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