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

Not Applicable

Not yet recruiting

• Conditions: End-Stage Renal Disease

• Registration Number: NCT06982573
• Lead Sponsor: Bundang CHA Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-11
• Study First Submitted QC: 2025-05-18
• Last Update Submitted: 2025-05-18
• Study Start: 2025-05-20
• Study First Posted: 2025-05-21
• Last Update Posted: 2025-05-21
• Primary Completion: 2026-02-19
• Study Completion: 2026-02-19

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Visual Analogue Sclae (VAS)	7 days before intervention/1 day after intervention/1 month after intervention	An assessment in which the subject quantifies the level of pain numerically from 0 to 10. The higher the number, the more intense the pain.

Secondary Outcome Measures

Name	Time	Method
Short Physical Performance Battery (SPPB)	7 days before intervention/1 day after intervention/1 month after intervention	Measures balance, lower extremity strength, and functional ability on a scale of 0 to 16. Higher scores indicate better function.
The World Health Organization (WHOQOL-BREF)	7 days before intervention/1 day after intervention/1 month after intervention	The WHOQOL-BREF consists of 26 items, with scores ranging from 1 to 5. A higher score indicates a higher quality of life.
3D Motion Capture	7 days before intervention/1 day after intervention/1 month after intervention	Collecting human body movement data using a 3D infrared camera and ground reaction force device
Dual Energy X-ray Absorptionmetry (DEXA)	7 days before intervention/1 day after intervention/1 month after intervention	A test that measures muscle mass by utilizing the energy absorption properties of high-energy and low-energy X-rays.