Constipation, Electrotherapy
Conditions
Keywords
Quality of Life, Magnetic Fields
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.
Interventions
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.
OTHERStandard Care Group
The standard care group received "training on how to manage constipation".
OTHERSham (No Treatment)
The sham group underwent the same procedure without active stimulation.
Sponsors
Medipol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This was a three-arm, parallel-group interventional study. Participants were randomly assigned to active transabdominal magnetic field therapy, sham intervention, or standard care.
Eligibility
Sex/Gender
ALL
Age
18 Years to 68 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Constipation Severity Instrument (CSI) | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient Assessment of Constipation Quality of Life (PAC-QOL) | 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. |
| Bristol Stool Scale | 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. |
| Complete spontaneous bowel movements (CSBM) | 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. |
| Defecation time | 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. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATOREsra Atilgan, PhD
Medipol University
PRINCIPAL_INVESTIGATORGizem Boztas Elverisli, PhD
Medipol University
Outcome results
None listed