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NCT Number: NCT06578442

Effectiveness of Electromagnetic Field Therapy in Chronic Constipation

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.

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Key information

Conditions

Constipation Electrotherapy Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University

Istanbul, Beykoz, 34100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Standard Care Group

Other

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

Sham (No Treatment)

Other

The sham group underwent the same procedure without active stimulation.

Primary outcomes

  1. Constipation Severity Instrument (CSI)

    Time frame: Eight weeks

    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.

Secondary outcomes

  1. Patient Assessment of Constipation Quality of Life (PAC-QOL)

    Time frame: Eight weeks

    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.

  2. Bristol Stool Scale

    Time frame: Eight weeks

    This is a scale that evaluates stool consistency. A high score indicates a more liquid stool consistency. Type 3-4 indicates normal stool.

  3. Complete spontaneous bowel movements (CSBM)

    Time frame: Eight weeks

    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.

  4. Defecation time

    Time frame: Eight weeks

    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.

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Aug 29, 2024
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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