NCT06982573

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 21, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

August 6, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2026

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

7 months

First QC Date

May 11, 2025

Last Update Submit

September 15, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Short Physical Performance Battery (SPPB)

    7 days before intervention/1 day after intervention/1 month after intervention

  • The World Health Organization (WHOQOL-BREF)

    7 days before intervention/1 day after intervention/1 month after intervention

  • 3D Motion Capture

    7 days before intervention/1 day after intervention/1 month after intervention

  • Dual Energy X-ray Absorptionmetry (DEXA)

    7 days before intervention/1 day after intervention/1 month after intervention

Study Arms (1)

End-Stage Renal Disease patients

EXPERIMENTAL
Device: Effects of applying magnetic stimulation

Interventions

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

End-Stage Renal Disease patients

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHA Bundang Medical Center, CHA University

Seongnam-si, Gyeonggi-do, 463-712, South Korea

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kim Minyoung, M.D., Ph.D

    Bundang CHA Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chung Eun Hye, M.S

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

May 11, 2025

First Posted

May 21, 2025

Study Start

August 6, 2025

Primary Completion

February 19, 2026

Study Completion

February 19, 2026

Last Updated

September 19, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations