Functional ConstipationNCT04710654
Effects of Different Physiotherapy Programs on Functional Constipation
A study testing connective tissue manipulation, Interferential current stimulation (100 Hz frequency) and Interferential current stimulation (0-100 Hz frequency) in people with Functional Constipation, run by Muş Alparslan University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Functional Constipation
- What is being tested?
- connective tissue manipulation, Interferential current stimulation (100 Hz frequency) and Interferential current stimulation (0-100 Hz frequency)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2021to 16 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Different Physiotherapy Programs on Symptoms and Quality of Life in Individuals With Functional Constipation
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.
Read the 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.
- Conditions
- Functional Constipation
- Being tested
- connective tissue manipulation, Interferential current stimulation (100 Hz frequency), Interferential current stimulation (0-100 Hz frequency), behavioural therapy, exercise program
- Keywords
- functional constipation, connective tissue manipulation, interferential current stimulation, exercise, behavioural therapy, conservative treatment
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
connective tissue manipulationOther
Also called behavioural therapy, exercise program
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.
Interferential current stimulation (100 Hz frequency)Other
Also called behavioural therapy, exercise program
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.
Interferential current stimulation (0-100 Hz frequency)Other
Also called behavioural therapy, exercise program
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 therapyOther
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 programOther
Exercise program consisting of physical activity, core stabilization exercises and pelvic floor muscle exercises.
"Exercise Program Booklet" will be prepared within the exercise training.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | 1. Behavioural therapy
2. Exercise program Receives: Other: behavioural therapy; Other: exercise program |
| connective tissue manipulation | Active comparator | Not described Receives: Other: connective tissue manipulation; Other: behavioural therapy; Other: exercise program |
| Interferential current stimulation (100 Hz frequency) | Active comparator | Not described Receives: Other: Interferential current stimulation (100 Hz frequency); Other: behavioural therapy; Other: exercise program |
| Interferential current stimulation (0-100 Hz frequency) | Active comparator | Not described Receives: Other: Interferential current stimulation (0-100 Hz frequency); Other: behavioural therapy; Other: exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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 (4)
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.
Measured: 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.
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."
Measured: 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.
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.
Measured: The end of the four-week intervention program
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.
Measured: At the baseline, the end of the four-week intervention program and after one month intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start1 May 2021
- Primary completion16 Jul 2022
- Study completion16 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Functional ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muş Alparslan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Semiha Yenişehir, Muş Alparslan University
- Investigators
- SEMİHA YENİŞEHİR, Principal investigator, Muş Alparslan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04710654
- Sponsor's protocol ID
- 01.12.2020-E.13987
- Status last verified
- Aug 2022
- First submitted
- 9 Jan 2021
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31690829Moore 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.
PubMed 32128859Sharifi-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.
PubMed 29257143Gursen 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.
PubMed 26099205Silva 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.
PubMed 23375005
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Physiotherapy Programs on Symptoms and Quality of Life in Individuals With Functional Constipation
- ClinicalTrials.gov ID
- NCT04710654
- Acronym / sponsor ID
- 01.12.2020-E.13987
- Conditions
- Functional Constipation
- Keywords
- functional constipation, connective tissue manipulation, interferential current stimulation, exercise, behavioural therapy, conservative treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Muş Alparslan UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 16 Jul 2022 (actual)
- Study completion
- 16 Aug 2022 (actual)
- First posted
- 15 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: behavioural therapy, Other: exercise program1. Behavioural therapy 2. Exercise program |
| connective tissue manipulation | Active comparator | Other: connective tissue manipulation, Other: behavioural therapy, Other: exercise program |
| Interferential current stimulation (100 Hz frequency) | Active comparator | Other: Interferential current stimulation (100 Hz frequency), Other: behavioural therapy, Other: exercise program |
| Interferential current stimulation (0-100 Hz frequency) | Active comparator | Other: Interferential current stimulation (0-100 Hz frequency), Other: behavioural therapy, Other: exercise program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| connective tissue manipulationAlso: behavioural therapy, exercise programIndividuals 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. | Other | connective tissue manipulation |
| Interferential current stimulation (100 Hz frequency)Also: behavioural therapy, exercise programThe 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. | Other | Interferential current stimulation (100 Hz frequency) |
| Interferential current stimulation (0-100 Hz frequency)Also: behavioural therapy, exercise programThe 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. | Other | Interferential current stimulation (0-100 Hz frequency) |
| behavioural therapyThe 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. | Other | Control, Interferential current stimulation (0-100 Hz frequency), Interferential current stimulation (100 Hz frequency), connective tissue manipulation |
| exercise programExercise program consisting of physical activity, core stabilization exercises and pelvic floor muscle exercises. "Exercise Program Booklet" will be prepared within the exercise training. | Other | Control, Interferential current stimulation (0-100 Hz frequency), Interferential current stimulation (100 Hz frequency), connective tissue manipulation |
Primary outcome
change in severity and symptoms of constipation
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.
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
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.
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.
4 secondary outcomes
bowel diary
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.
physical activity level
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.
treatment satisfaction
Time frame: The end of the four-week intervention program
stool consistency
Time frame: At the baseline, the end of the four-week intervention program and after one month intervention period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Background: PubMed 31690829Vriesman 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.
- Background: PubMed 32128859Moore 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.
- Background: PubMed 29257143Sharifi-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.
- Background: PubMed 26099205Gursen 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.
- Background: PubMed 23375005Silva 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SEMİHA YENİŞEHİR principal investigator
Muş Alparslan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing connective tissue manipulation, Interferential current stimulation (100 Hz frequency) and Interferential current stimulation (0-100 Hz frequency) in people with Functional Constipation, run by Muş Alparslan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in severity and symptoms of constipation (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04710654, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2022.