Effectiveness of Electromagnetic Field Therapy in Chronic Constipation

NCT06578442 | Completed

• 1 other identifier: E-10840098-50.04-2843
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This study was a prospective randomise controlled study. The aim of this study was to determine the effect of transabdominal magnetic field therapy on constipation severity in patients with chronic functional constipation. After eligibility assessment and baseline measurements, participants were randomly allocated into three groups: the transabdominal magnetic field therapy group, the sham group, and the standard care group. All groups received Constipation Management Education. The education program, developed based on the literature, covered the definition, causes, risk factors, medication use, and lifestyle-related factors associated with constipation. In addition, behavioral recommendations were provided, including maintaining regular bowel habits, adopting an appropriate defecation posture, avoiding delayed defecation and excessive straining, and optimizing diet, fluid intake, and physical activity. The MFT group received active transabdominal magnetic field therapy twice weekly for 8 weeks. The sham group underwent the same device placement and session protocol; however, the device was used without delivering an active magnetic field. The standard care group received only Constipation Management Education. Participants were followed face to face for 8 weeks, and individual counseling was provided when needed to answer their questions. The primary outcome measure was the Constipation Severity Instrument (CSI). Secondary outcomes were the CSI subscales, the Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL), the Bristol Stool Form Scale, complete spontaneous bowel movements (CSBM), and defecation time.

Conditions

Constipation; Electrotherapy

Keywords

Quality of Life; Magnetic Fields

Outcome Measures

Primary Outcomes (1)

• Constipation Severity Instrument (CSI)

  It is a scale that reveals the symptoms of constipation in people. It makes an evaluation to determine the problems experienced by individuals in defecation. The scale includes 16 questions. The lowest total score that can be obtained from the scale is 0 and the highest is 73. A high score indicates that the symptoms are serious.

  Eight weeks

Secondary Outcomes (4)

• Patient Assessment of Constipation Quality of Life (PAC-QOL)

  Eight weeks

• Bristol Stool Scale

  Eight weeks

• Complete spontaneous bowel movements (CSBM)

  Eight weeks

• Defecation time

  Eight weeks

Study Arms (3)

Treatment group

EXPERIMENTAL

Magnetic Field Treatment was applied to the participants for 30 minutes a day, twice a week for 8 weeks, using an electromagnetic field therapy device, in a supine position, by placing circular magnetotherapy electrodes in the abdominal area, at 25 Hz and 30 Gauss power.

Other: Magnetic Field Treatment; Other: Standard Care Group

Standard Care Group

ACTIVE COMPARATOR

Standard Care Group group was given "constipation coping training".

Other: Standard Care Group

Sham

SHAM COMPARATOR

The sham group underwent the same procedure without active magnetic stimulation. Magnetic Field Therapy was administered to participants in a supine position, with circular magnetotherapy electrodes placed on the abdominal area using an electromagnetic field therapy device. The treatment lasted 30 minutes twice a week for 8 weeks, with no current flowing through the device during the sham application.

Other: Standard Care Group; Other: Sham (No Treatment)

Interventions

Magnetic Field Treatment OTHER

Magnetic Field Treatment was applied to the participants for 30 minutes a day, twice a week for 8 weeks, using an electromagnetic field therapy device, in a supine position, by placing circular magnetotherapy electrodes in the abdominal area, at 25 Hz and 30 Gauss power.

Treatment group

Sham (No Treatment) OTHER

The sham group underwent the same procedure without active stimulation.

Sham

Standard Care Group OTHER

The standard care group received "training on how to manage constipation".

Sham; Standard Care Group; Treatment group

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of chronic constipation according to Rome III criteria
• Ages of 18-68
• Indicate magnetotherapy treatment,
• Not having used any medication for constipation during the treatment
• Fully cooperative

You may not qualify if:

• Severely obese patients
• Electrical implants in their body
• First trimester of pregnancy
• Implanted inner ear implants
• Small implants that may be affected by the magnetic field
• Epilepsy
• Untreated hypertoid
• High fever

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, Beykoz, 34100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Constipation

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Esra Atilgan, PhD

  Medipol University

  PRINCIPAL INVESTIGATOR

• Gizem Boztas Elverisli, PhD

  Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This was a three-arm, parallel-group interventional study. Participants were randomly assigned to active transabdominal magnetic field therapy, sham intervention, or standard care.

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: August 29, 2024
• Study Start: February 1, 2019
• Primary Completion: April 28, 2026
• Study Completion: April 28, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)