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Effects of Different Physiotherapy Programs on Functional Constipation

M

Muş Alparlan University

Status

Completed

Conditions

Functional Constipation

Treatments

Other: exercise program
Other: behavioural therapy
Other: Interferential current stimulation (100 Hz frequency)
Other: connective tissue manipulation
Other: Interferential current stimulation (0-100 Hz frequency)

Study type

Interventional

Funder types

Other

Identifiers

NCT04710654
01.12.2020-E.13987

Details and patient eligibility

About

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.

Full description

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.

Enrollment

52 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

52 participants in 4 patient groups

Control
Other group
Description:
1. Behavioural therapy 2. Exercise program
Treatment:
Other: behavioural therapy
Other: exercise program
connective tissue manipulation
Active Comparator group
Treatment:
Other: behavioural therapy
Other: exercise program
Other: connective tissue manipulation
Interferential current stimulation (100 Hz frequency)
Active Comparator group
Treatment:
Other: behavioural therapy
Other: exercise program
Other: Interferential current stimulation (100 Hz frequency)
Interferential current stimulation (0-100 Hz frequency)
Active Comparator group
Treatment:
Other: Interferential current stimulation (0-100 Hz frequency)
Other: behavioural therapy
Other: exercise program

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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