Clinical trial NCT04710654: 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
Overall status: COMPLETED
Phase: NA
Conditions: Functional Constipation
Keywords: functional constipation
connective tissue manipulation
interferential current stimulation
exercise
behavioural therapy
conservative treatment
Lead sponsor: Muş Alparslan University
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: change in severity and symptoms of constipation
timeFrame: 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.
measure: change in quality of life
timeFrame: 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 outcomes:
measure: bowel diary
timeFrame: 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.
measure: physical activity level
timeFrame: 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.
measure: treatment satisfaction
timeFrame: The end of the four-week intervention program
measure: stool consistency
timeFrame: At the baseline, the end of the four-week intervention program and after one month intervention period.
Other outcomes:
Locations:
city: Muş
country: Turkey
facility: Semiha Yenişehir
Study officials:
affiliation: Muş Alparslan University
name: SEMİHA YENİŞEHİR
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.