Clinical trial NCT06982573: The Effect of Magnetic Stimulation on Low Back Pain Relief and Muscle Mass Maintenance in Patients With ESRD
Official title: The Effect of Magnetic Stimulation on Low Back Pain Relief and Muscle Mass Maintenance in Patients With End-Stage Renal Disease (ESRD)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: End-Stage Renal Disease
Lead sponsor: Bundang CHA Hospital
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 18
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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


Eligibility criteria: Inclusion Criteria:

1. Adults aged 19 years or older
2. Patients diagnosed with end-stage renal failure and receiving dialysis treatment more than three times a week
3. Back pain intensity of 4 points or higher on the visual analogue scale (VAS)
4. 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) \[14\]
5. 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

Exclusion Criteria:

1. If the pain is due to trauma
2. If it is difficult to participate in the study due to serious mental illness (e.g. schizophrenia, bipolar disorder, etc.) or psychological instability.
3. Patients with severe neurological illness (e.g. stroke, severe dementia, etc.).
4. Those with poor general condition due to unstable cardiovascular, digestive, respiratory, or endocrine systems, or severe internal medical illness such as systemic infection
5. 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)
6. 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

Primary outcomes:
measure: Visual Analogue Sclae (VAS)
timeFrame: 7 days before intervention/1 day after intervention/1 month after intervention
Secondary outcomes:
measure: Short Physical Performance Battery (SPPB)
timeFrame: 7 days before intervention/1 day after intervention/1 month after intervention
measure: The World Health Organization (WHOQOL-BREF)
timeFrame: 7 days before intervention/1 day after intervention/1 month after intervention
measure: 3D Motion Capture
timeFrame: 7 days before intervention/1 day after intervention/1 month after intervention
measure: Dual Energy X-ray Absorptionmetry (DEXA)
timeFrame: 7 days before intervention/1 day after intervention/1 month after intervention
Other outcomes:
Locations:
Study officials:
affiliation: Bundang CHA Hospital
name: Kim Minyoung, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: