Effectiveness of Electromagnetic Field Therapy in Chronic Constipation

Effects of Transabdominal Magnetic Field Therapy on Constipation Severity in Chronic Functional Constipation: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Constipation; Electrotherapy
• Intervention / Treatment: Other: Magnetic Field Treatment; Other: Standard Care Group; Other: Sham (No Treatment)

Detailed Description

This study was carried out in the laboratory of Istanbul Medipol University Physiotherapy and Rehabilitation department on participants between February 2019 and January 2020 and were diagnosed with chronic constipation.

This study was conducted in accordance with the principles of human experimentation specified in the Declaration of Helsinki and with ethics committee approval. Informed consent forms were obtained from the participants.

52 participants were included in our study. The study was completed with 40 participants. Evaluations were made twice, before and after treatment. Magnetic field treatmentwas 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 magnetic field treatment electrodes in the abdominal area, at a power of 25 Hz and 30 Gauss. Participants were informed about the things to consider in magnetic field treatment. To determine the effectiveness of the treatment, evaluations were made before and after the treatment using the Constipation Severity Scale, Constipation Quality of Life Scale, International Physical Activity Questionnaire.

Magnetic field therapy provided improvement in subparameters such as difficulty in defecation, slowing of colon movements, pain due to constipation and increased quality of life due to constipation.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Beykoz
    • Istanbul, Beykoz, Turkey (Türkiye), 34100
      • İstanbul Medipol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; 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; 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: Standard Care Group; The standard care group received "training on how to manage constipation".
Active Comparator: Standard Care Group; Standard Care Group group was given "constipation coping training".	Other: Standard Care Group; The standard care group received "training on how to manage constipation".
Sham Comparator: Sham; 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; The standard care group received "training on how to manage constipation".; Other: Sham (No Treatment); The sham group underwent the same procedure without active stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Assessment of Constipation Quality of Life (PAC-QOL)	Quality of life was assessed using the Turkish adaptation of the Patient Assessment of Constipation Quality of Life(PAC-QOL). The PAC-QOL consists of 28 questions, including subscales for "physical discomfort," "psychosocial discomfort," "concerns/worries," and "satisfaction." The highest possible score is 140, and the lowest is 28. Higher scores indicate that constipation negatively impacts quality of life more significantly.	Eight weeks
Bristol Stool Scale	This is a scale that evaluates stool consistency. A high score indicates a more liquid stool consistency. Type 3-4 indicates normal stool.	Eight weeks
Complete spontaneous bowel movements (CSBM)	This is a medical term referring to bowel movements that occur naturally without medication, and without straining, pain, or a feeling of incomplete emptying during defecation.	Eight weeks
Defecation time	It describes the frequency of bowel movements, the consistency of the stool, and the degree of difficulty a person experiences during defecation. It is recorded in minutes. A longer duration indicates difficulty in defecation.	Eight weeks

Collaborators and Investigators

• Sponsor: Medipol University
• Investigators: Principal Investigator: Esra Atilgan, PhD, Medipol University; Principal Investigator: Gizem Boztas Elverisli, PhD, Medipol University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): April 28, 2026
• Study Completion (Actual): April 28, 2026

Study Registration Dates

• First Submitted: March 12, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Quality of Life; Magnetic Fields
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Constipation; salicylhydroxamic acid
• Other Study ID Numbers: E-10840098-50.04-2843

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
• product manufactured in and exported from the U.S.: No