Effects of Different Physiotherapy Programs on Functional Constipation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2022-08-16

Brief Summary

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This study compares the effectiveness of a more comprehensive behavioral treatment, physical activity and exercise program, as well as CTM and IF current stimulation approaches at different frequencies on functional constipation symptoms and quality of life, compared to their counterparts in the literature.

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Detailed Description

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Functional constipation (FC), which is characterized by conditions such as excessive straining and difficulty in defecation, infrequent bowel movements, and incomplete defecation, is a common bowel disease that causes activity limitation and decrease in quality of life in children and adults, regardless of an organic etiology.

In the literature, there are studies showing the effectiveness of different physiotherapy approaches such as behavioral therapy, exercise, neuromodulation applications, kinesiotape, abdominal massage in FC, and investigate and compare the effectiveness of connective tissue manipulation (CTM) and interferential (IF) current stimulation applied in addition to behavioral therapy and exercise program. But there was any study which compare the effectiveness of these physiotherapy methods with each other and IF current stimulation at different frequencies (100 Hz and 0-100 Hz). In addition, there are no randomized controlled studies comparing the current effects of IF applied at 100 Hz and 0-100 Hz in individuals with FC.

The treatment methods to be applied in this study are behavioral therapy, physical activity and exercise program, CTM and IF current stimulation applied at a frequency of 100 Hz and 0-100 Hz.

The diagnostic method to be used is based on the Rome IV FC Criteria and the Bristol Stool Form Scale.

Conditions

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Functional Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control

1. Behavioural therapy
2. Exercise program

Group Type OTHER

behavioural therapy

Intervention Type OTHER

The behavioral therapy includes patient education (description of the disease, symptoms, risk factors, treatment, defecation mechanism and informing about negative attitudes and behaviors towards defecation), lifestyle advices (diet, water consumption, fiber food, etc.), teaching effective defecation posture, timed toilet training, self-abdominal massage.

"Constipation Behavioral Therapy Booklet" will be prepared within the scope of behavioral therapy.

exercise program

Intervention Type OTHER

Exercise program consisting of physical activity, core stabilization exercises and pelvic floor muscle exercises.

"Exercise Program Booklet" will be prepared within the exercise training.

connective tissue manipulation

Group Type ACTIVE_COMPARATOR

connective tissue manipulation

Intervention Type OTHER

Individuals in CTM group, will sit on a stool with hips and knees flexed at 90° and their hands free on the thighs. The application will start from the basic area in the first session, and in the other sessions, the lower thoracic, scapular, inter-scapular and cervical regions will be included in the treatment as soon as possible according to the state of the vascular reaction. CTM will be applied three days a week, for four weeks.

behavioural therapy

Intervention Type OTHER

The behavioral therapy includes patient education (description of the disease, symptoms, risk factors, treatment, defecation mechanism and informing about negative attitudes and behaviors towards defecation), lifestyle advices (diet, water consumption, fiber food, etc.), teaching effective defecation posture, timed toilet training, self-abdominal massage.

"Constipation Behavioral Therapy Booklet" will be prepared within the scope of behavioral therapy.

exercise program

Intervention Type OTHER

Exercise program consisting of physical activity, core stabilization exercises and pelvic floor muscle exercises.

"Exercise Program Booklet" will be prepared within the exercise training.

Interferential current stimulation (100 Hz frequency)

Group Type ACTIVE_COMPARATOR

Interferential current stimulation (100 Hz frequency)

Intervention Type OTHER

The four electrodes (superficial, self-adhesive, 5x9 cm rectangular) coming out of the two channels will be used. Two of the electrodes will be placed bilaterally at the level of the spinal segment, T9-L2, where the sympathetic fibers of the gastrointestinal tract are innervated, in the posterior region, and the other two will be placed anteriorly on the umbilicus lateral to the abdomen. The current will be applied at the sensory level, increasing to the extent that the patient feels the current effectively but does not reveal pain, discomfort and visible muscle contractions. The application will be made to the individuals at 100 Hz frequency three days a week, for four weeks.

behavioural therapy

Intervention Type OTHER

The behavioral therapy includes patient education (description of the disease, symptoms, risk factors, treatment, defecation mechanism and informing about negative attitudes and behaviors towards defecation), lifestyle advices (diet, water consumption, fiber food, etc.), teaching effective defecation posture, timed toilet training, self-abdominal massage.

"Constipation Behavioral Therapy Booklet" will be prepared within the scope of behavioral therapy.

exercise program

Intervention Type OTHER

Exercise program consisting of physical activity, core stabilization exercises and pelvic floor muscle exercises.

"Exercise Program Booklet" will be prepared within the exercise training.

Interferential current stimulation (0-100 Hz frequency)

Group Type ACTIVE_COMPARATOR

Interferential current stimulation (0-100 Hz frequency)

Intervention Type OTHER

The four electrodes (superficial, self-adhesive, 5x9 cm rectangular) coming out of the two channels will be used. Two of the electrodes will be placed bilaterally at the level of the spinal segment, T9-L2, where the sympathetic fibers of the gastrointestinal tract are innervated, in the posterior region, and the other two will be placed anteriorly on the umbilicus lateral to the abdomen. The current will be applied at the sensory level, increasing to the extent that the patient feels the current effectively but does not reveal pain, discomfort and visible muscle contractions. The application will be made to the individuals at 0-100 Hz frequency three days a week, for four weeks.

behavioural therapy

Intervention Type OTHER

The behavioral therapy includes patient education (description of the disease, symptoms, risk factors, treatment, defecation mechanism and informing about negative attitudes and behaviors towards defecation), lifestyle advices (diet, water consumption, fiber food, etc.), teaching effective defecation posture, timed toilet training, self-abdominal massage.

"Constipation Behavioral Therapy Booklet" will be prepared within the scope of behavioral therapy.

exercise program

Intervention Type OTHER

Exercise program consisting of physical activity, core stabilization exercises and pelvic floor muscle exercises.

"Exercise Program Booklet" will be prepared within the exercise training.

Interventions

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connective tissue manipulation

Individuals in CTM group, will sit on a stool with hips and knees flexed at 90° and their hands free on the thighs. The application will start from the basic area in the first session, and in the other sessions, the lower thoracic, scapular, inter-scapular and cervical regions will be included in the treatment as soon as possible according to the state of the vascular reaction. CTM will be applied three days a week, for four weeks.

Intervention Type OTHER

Interferential current stimulation (100 Hz frequency)

The four electrodes (superficial, self-adhesive, 5x9 cm rectangular) coming out of the two channels will be used. Two of the electrodes will be placed bilaterally at the level of the spinal segment, T9-L2, where the sympathetic fibers of the gastrointestinal tract are innervated, in the posterior region, and the other two will be placed anteriorly on the umbilicus lateral to the abdomen. The current will be applied at the sensory level, increasing to the extent that the patient feels the current effectively but does not reveal pain, discomfort and visible muscle contractions. The application will be made to the individuals at 100 Hz frequency three days a week, for four weeks.

Intervention Type OTHER

Interferential current stimulation (0-100 Hz frequency)

The four electrodes (superficial, self-adhesive, 5x9 cm rectangular) coming out of the two channels will be used. Two of the electrodes will be placed bilaterally at the level of the spinal segment, T9-L2, where the sympathetic fibers of the gastrointestinal tract are innervated, in the posterior region, and the other two will be placed anteriorly on the umbilicus lateral to the abdomen. The current will be applied at the sensory level, increasing to the extent that the patient feels the current effectively but does not reveal pain, discomfort and visible muscle contractions. The application will be made to the individuals at 0-100 Hz frequency three days a week, for four weeks.

Intervention Type OTHER

behavioural therapy

The behavioral therapy includes patient education (description of the disease, symptoms, risk factors, treatment, defecation mechanism and informing about negative attitudes and behaviors towards defecation), lifestyle advices (diet, water consumption, fiber food, etc.), teaching effective defecation posture, timed toilet training, self-abdominal massage.

"Constipation Behavioral Therapy Booklet" will be prepared within the scope of behavioral therapy.

Intervention Type OTHER

exercise program

Exercise program consisting of physical activity, core stabilization exercises and pelvic floor muscle exercises.

"Exercise Program Booklet" will be prepared within the exercise training.

Intervention Type OTHER

Other Intervention Names

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behavioural therapy exercise program behavioural therapy exercise program behavioural therapy exercise program

Eligibility Criteria

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Inclusion Criteria

* being able to read and write in Turkish,
* being between 18 and 65 years of age
* having a diagnosis of functional constipation according to Rome IV criteria
* having body mass index \<35 kg/m2

Exclusion Criteria

* being pregnant
* having comorbidities (chronic pelvic pain, neurological (Parkinson's, Multiple sclerosis, Spinal cord lesion, etc.), metabolic / endocrine (Diabetes Mellitus, hypercalcemia, hypothyroid, etc.), cardiorespiratory diseases
* health problems which may prevent standing from sitting, walking (orthopedic, neurological, cardiorespiratory, etc.)
* malignancy, acute inflammation, intestinal tumor
* history of gastrointestinal and pelvic surgery or spinal surgery other than cholecystectomy, appendectomy, or hysterectomy
* contraindications to Interferential Current (thrombosis, pacemaker, metal implant etc.)
* visual, auditory or cognitive problems which may prevent participation to the study
* tumor, presence of skin problems in the application area
* presence of laxative use for functional constipation in the last four weeks
* alarm symptoms (unexplained, more than 10% weight loss in 3 months, hemorrhoids and anal fissures, rectal bleeding, family history of colon cancer)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No