Clinical trial NCT06578442: Effectiveness of Electromagnetic Field Therapy in Chronic Constipation
Official title: Determining the Effect of Electromagnetic Field Treatment on Individuals With Chronic Constipation: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Electrotherapy
Keywords: Quality of Life
Magnetic Fields
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups with a conventional therapy
Primary purpose: TREATMENT

Brief summary: The aim of the study is to examine the effects of magnetic field therapy on individuals with chronic constipation. 40 individuals with chronic constipation between the ages of 18-68 who met the inclusion criteria were included in the study. Participants were divided into two groups: treatment group (n=20) and control group (n=2O). The control group was given "constipation coping training" and asked to perform the taught methods every day for 8 weeks. Whether the individuals applied the methods was checked via telehabilitation. Participants in the treatment group received magnetic field therapy twice a week for 8 weeks. Participants were evaluated with the Constipation Severity Scale, Constipation Quality of Life Scale and International Physical Activity Questionnaire before and after the treatment.

Magnetic field therapy provides improvement in sub-parameters such as difficulty in defecation, slowing down of colon movements, and pain due to constipation. It has provided an increase in the quality of life due to constipation. Magnetic field therapy can be applied as an alternative treatment method for the treatment of individuals with chronic constipation problems.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Constipation Severity Scale (CSS)
timeFrame: Four weeks
measure: Constipation Quality of Life Scale
timeFrame: Four weeks
Secondary outcomes:
measure: International Physical Activity Survey-Short Form (IPAQ-SF)
timeFrame: Four weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
state: Beykoz
Study officials:
affiliation: Medipol University
name: Esra Atilgan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medipol University
name: Gizem Boztas Elverisli, PhD
role: PRINCIPAL_INVESTIGATOR
References: