The Effect of Magnetic Stimulation on Low Back Pain Relief and Muscle Mass Maintenance in Patients With ESRD

Официальное название

The Effect of Magnetic Stimulation on Low Back Pain Relief and Muscle Mass Maintenance in Patients With End-Stage Renal Disease (ESRD)

Обзор

To determine the effectiveness of magnetic stimulation application on alleviating back pain and maintaining muscle mass in patients with end-stage renal disease.

Вмешательства

• Устройство Effects of applying magnetic stimulation
  The Effect of Magnetic Stimulation on Low Back Pain Relief and Muscle Mass Maintenance in Patients with End-Stage Renal Disease (ESRD)

Первичные конечные точки

• Visual Analogue Sclae (VAS) [Срок оценки: 7 days before intervention/1 day after intervention/1 month after intervention]

Вторичные конечные точки (4)

• Short Physical Performance Battery (SPPB) [Срок оценки: 7 days before intervention/1 day after intervention/1 month after intervention]
• The World Health Organization (WHOQOL-BREF) [Срок оценки: 7 days before intervention/1 day after intervention/1 month after intervention]
• 3D Motion Capture [Срок оценки: 7 days before intervention/1 day after intervention/1 month after intervention]
• Dual Energy X-ray Absorptionmetry (DEXA) [Срок оценки: 7 days before intervention/1 day after intervention/1 month after intervention]

Критерии участия

Критерии включения

• Adults aged 19 years or older
• Patients diagnosed with end-stage renal failure and receiving dialysis treatment more than three times a week
• Back pain intensity of 4 points or higher on the visual analogue scale (VAS)
• Those with cognitive function that can clearly indicate NRS with a score of 23 points or higher, the criterion for determining cognitive impairment on the Mini Mental State Examination (MMSE) \[14\]
• Those who voluntarily decided to participate in this clinical trial after receiving a detailed explanation and fully understanding it and gave written consent to comply with the precautions

Критерии исключения

• If the pain is due to trauma
• If it is difficult to participate in the study due to serious mental illness (e.g. schizophrenia, bipolar disorder, etc.) or psychological instability.
• Patients with severe neurological illness (e.g. stroke, severe dementia, etc.).
• Those with poor general condition due to unstable cardiovascular, digestive, respiratory, or endocrine systems, or severe internal medical illness such as systemic infection
• Patients participating in other therapeutic clinical trials or those who have participated in other therapeutic clinical trials within the past 30 days (observational studies are not relevant)
• If there are contraindications to magnetic stimulation

• Patients with implanted medical devices (e.g. pacemakers)
• Metal objects are inserted into the skull
• A wound on the skin at the attachment site
• History of epilepsy
• Cervical pain or musculoskeletal disease
• Pregnant and lactating women

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

South Korea · 1 центр

• CHA Bundang Medical Center, CHA University — Seongnam-si

Идентификаторы

NCT: NCT06982573 · 2025-01-031

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗