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Effects of Different Physiotherapy Programs on Functional Constipation

Primary Purpose

Functional Constipation

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

connective tissue manipulation

Interferential current stimulation (100 Hz frequency)

Interferential current stimulation (0-100 Hz frequency)

behavioural therapy

exercise program

About this trial

This is an interventional treatment trial for Functional Constipation focused on measuring functional constipation, connective tissue manipulation, interferential current stimulation, exercise, behavioural therapy, conservative treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

Semiha Yenişehir

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Active Comparator

Arm Label

Control

connective tissue manipulation

Interferential current stimulation (100 Hz frequency)

Interferential current stimulation (0-100 Hz frequency)

Arm Description

Behavioural therapy Exercise program

Outcomes

Primary Outcome Measures

change in severity and symptoms of constipation

Turkish version of Constipation Severity Instrument (CSI) will be used to evaluate the severity of the constipation. The Constipation Severity Instrument is a 16-item patient-reported outcome measure that investigates symptoms of constipation based on frequency, severity, and bother of symptoms. CSI consists of three subscales: obstructive defecation, colonic inertia and pain. Higher scores of CSI indicate more severe constipation.

change in quality of life

Turkish version of Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) will be used to evaluate quality of life. PAC-QOL consists a total of 28 items in four subscales: worries and concerns (11 items), physical discomfort (4 items), psychosocial discomfort (8 items), and satisfaction (5 items). Higher scores of PAC-QOL indicate more negative effects of constipation on the quality of life.

Secondary Outcome Measures

bowel diary

Before and after treatment, bowel habits will be evaluated with a seven-day Bowel Diary. Intestinal diary with date and time, food/drink consumed, medication (type + amount), bowel urgency? (Rate 1 mild - 3 strong), pain and discomfort (1: mild, 3: strong), voiding time, Bristol Stool Scale Type will be recorded if there is any accident / leak.

physical activity level

Turkish-International Physical Activity Questionnaire-Short Form (IPAQ-SF) will be used to evaluate level of physcial activity of participants. The IPAQ-SF is a self-reported measure consists of seven items. It asks four intensity levels: vigorous-intensity activities, moderate-intensity activities, walking and sitting. The total score is the summation of the duration and frequency of walking, moderate-intensity, and vigorous-intensity activity. The total score was reported as "Metabolic Equivalent of Task-min/week." The sitting time is reported separately as "h/day."

treatment satisfaction

The level of satisfaction with the treatment will be evaluated with the Visual Analogue Scale (VAS). On the 10 cm long line, the starting point will be determined as 0 cm "not at all satisfied" and 10 cm poin indicated "very satisfied". The distances of the points marked on the VAS to the 0 cm point will be measured and recorded with a ruler.

stool consistency

The Bristol Stool Scale (BGS) will be used evaluate stool consistency. The stool form is sensitive to the change in transit time. Type 1=separate hard lumps, like nuts; Type 2= gnarled, hard sausage but lumpy; Type 3=cracks on the surface like sausage; Type 4=Soft, smooth, sausage-like; Type 5=separate soft parts; Type 7=classified as liquid without solid particles. While Types 1 and 2 indicate constipation, Types 6 and 7 inflammation, Type 3 and Type 4 are considered normal.

Full Information

NCT ID

NCT04710654

First Posted

January 9, 2021

Last Updated

August 23, 2022

Sponsor

Muş Alparlan University

1. Study Identification

Unique Protocol Identification Number

NCT04710654

Brief Title

Effects of Different Physiotherapy Programs on Functional Constipation

Official Title

Effects of Different Physiotherapy Programs on Symptoms and Quality of Life in Individuals With Functional Constipation

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

May 1, 2021 (Actual)

Primary Completion Date

July 16, 2022 (Actual)

Study Completion Date

August 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Muş Alparlan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Functional Constipation

Keywords

functional constipation, connective tissue manipulation, interferential current stimulation, exercise, behavioural therapy, conservative treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Other

Arm Description

Behavioural therapy Exercise program

Arm Title

connective tissue manipulation

Arm Type

Active Comparator

Arm Title

Interferential current stimulation (100 Hz frequency)

Arm Type

Active Comparator

Arm Title

Interferential current stimulation (0-100 Hz frequency)

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

connective tissue manipulation

Other Intervention Name(s)

behavioural therapy, exercise program

Intervention Description

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

Intervention Name(s)

Interferential current stimulation (100 Hz frequency)

Other Intervention Name(s)

behavioural therapy, exercise program

Intervention Description

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

Intervention Name(s)

Interferential current stimulation (0-100 Hz frequency)

Other Intervention Name(s)

behavioural therapy, exercise program

Intervention Description

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

Intervention Name(s)

behavioural therapy

Intervention Description

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

Intervention Name(s)

exercise program

Intervention Description

Exercise program consisting of physical activity, core stabilization exercises and pelvic floor muscle exercises. "Exercise Program Booklet" will be prepared within the exercise training.

Primary Outcome Measure Information:

Title

change in severity and symptoms of constipation

Description

Time Frame

Participants will be applied intervention program for four weeks. Change in severity and symptoms of constipation will be assessed at the baseline, the end of the four-week intervention program and after one month intervention period.

Title

change in quality of life

Description

Time Frame

Participants will be applied intervention program for four weeks. Change in quality of life will be assessed at the baseline, the end of the four-week intervention program and after one month intervention period.

Secondary Outcome Measure Information:

Title

bowel diary

Description

Time Frame

Participants will be applied intervention program for four weeks. Bowel diary will be assessed at the baseline, the end of the four-week intervention program and after one month intervention period.

Title

physical activity level

Description

Time Frame

Participants will be applied intervention program for four weeks. The physical activity level will be assessed at the baseline, the end of the four-week intervention program and after one month intervention period.

Title

treatment satisfaction

Description

Time Frame

The end of the four-week intervention program

Title

stool consistency

Description

Time Frame

At the baseline, the end of the four-week intervention program and after one month intervention period.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

SEMİHA YENİŞEHİR

Organizational Affiliation

Muş Alparslan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Semiha Yenişehir

City

Muş

ZIP/Postal Code

49000

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31690829

Citation

Vriesman MH, Koppen IJN, Camilleri M, Di Lorenzo C, Benninga MA. Management of functional constipation in children and adults. Nat Rev Gastroenterol Hepatol. 2020 Jan;17(1):21-39. doi: 10.1038/s41575-019-0222-y. Epub 2019 Nov 5.

Results Reference

background

PubMed Identifier

32128859

Citation

Moore JS, Gibson PR, Burgell RE. Randomised clinical trial: transabdominal interferential electrical stimulation vs sham stimulation in women with functional constipation. Aliment Pharmacol Ther. 2020 Apr;51(8):760-769. doi: 10.1111/apt.15642. Epub 2020 Mar 3.

Results Reference

background

PubMed Identifier

29257143

Citation

Sharifi-Rad L, Ladi-Seyedian SS, Manouchehri N, Alimadadi H, Allahverdi B, Motamed F, Fallahi GH. Effects of Interferential Electrical Stimulation Plus Pelvic Floor Muscles Exercises on Functional Constipation in Children: A Randomized Clinical Trial. Am J Gastroenterol. 2018 Feb;113(2):295-302. doi: 10.1038/ajg.2017.459. Epub 2017 Dec 19.

Results Reference

background

PubMed Identifier

26099205

Citation

Gursen C, Kerem Gunel M, Kaya S, Kav T, Akbayrak T. Effect of Connective Tissue Manipulation on Symptoms and Quality of Life in Patients With Chronic Constipation: A Randomized Controlled Trial. J Manipulative Physiol Ther. 2015 Jun;38(5):335-43. doi: 10.1016/j.jmpt.2015.06.003. Epub 2015 Jun 20.

Results Reference

background

PubMed Identifier

23375005

Citation

Silva CA, Motta ME. The use of abdominal muscle training, breathing exercises and abdominal massage to treat paediatric chronic functional constipation. Colorectal Dis. 2013 May;15(5):e250-5. doi: 10.1111/codi.12160.

Results Reference

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Effects of Different Physiotherapy Programs on Functional Constipation

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