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

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

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

Study Overview

• Status: Recruiting
• Conditions: End-Stage Renal Disease
• Intervention / Treatment: Device: Effects of applying magnetic stimulation

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chung Eun Hye, M.S; Phone Number: 8867 +821032657071; Email: a230419@chamc.co.kr

Study Locations

• South Korea
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, South Korea, 463-712
      • Recruiting
      • CHA Bundang Medical Center, CHA University
      • Contact: Minyoung Kim, M.D., Ph.D.; Phone Number: 82-31-780-1872; Email: kmin@cha.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: End-Stage Renal Disease patients	Device: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Sclae (VAS)	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.	7 days before intervention/1 day after intervention/1 month after intervention

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bundang CHA Hospital
• Investigators: Principal Investigator: Kim Minyoung, M.D., Ph.D, Bundang CHA Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2025
• Primary Completion (Estimated): February 19, 2026
• Study Completion (Estimated): February 19, 2026

Study Registration Dates

• First Submitted: May 11, 2025
• First Submitted That Met QC Criteria: May 18, 2025
• First Posted (Actual): May 21, 2025

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 15, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Pathological Conditions, Signs and Symptoms; Kidney Failure, Chronic
• Other Study ID Numbers: 2025-01-031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No