ConstipationNCT03764995
The Effects of Abdominal Massage on Functional (Primary) Chronic Constipation
A study testing Standard bowel management and Abdominal massage in people with Constipation, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the present study is to investigate the efficacy of abdominal massage in patients with functional (primary) chronic constipation. The present study is designed as a randomized placebo controlled. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Constipation
- What is being tested?
- Standard bowel management and Abdominal massage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2018to 16 May 2019
- 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
- Age between 18 and 65 years.
- Diagnosed with chronic constipation according to Rome IV criteria
Who cannot join
- A recent history of abdominal surgery
- Intestinal obstruction, ileus, colon cancer
- Enteric neuropathic patients: Diabetic intestinal neuropathy, Hirschsprung's disease, Megacolon, Megarectum
- Umbilical hernia
- Metabolic diseases: Cancer, Chronic renal failure, Severe cardiovascular disease, Hepatic failure, Hepatosplenomegaly, Abdominal aortic aneurysm
- Neurological diseases: Parkinson, Spinal cord injury, Multiple sclerosis, Cerebro-vascular event,
- Paraplegia Mental problem to prevent co-operative treatment
- Pregnancy and lactation
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the present study is to investigate the efficacy of abdominal massage in patients with functional (primary) chronic constipation. The present study is designed as a randomized placebo controlled. Since the placebo group is included in the research design, if there is a greater improvement of symptoms of constipation and quality of life in the massage group when compared to the control group, it will be determined that this effect is not related to a placebo effect. If the efficacy of Abdominal Massage is revealed with a placebo controlled design, the therapist effect will be eliminated and further evidence on a well-known massage technique in functional (primary) chronic constipation, a common gastrointestinal problem, will be provided. The results of the present placebo controlled randomized trial will indicate that the need for pharmacological agents and the side effects associated with these agents will be reduced. According to the literature, there are studies that investigate the effects of abdominal massage on symptoms of constipation and quality of life. However, it has generally been used for secondary constipation or two applications have been compared. In addition, there is no randomized placebo-controlled study investigating the effect of abdominal massage on severity of chronic constipation and quality of life.
Read the detailed description
Constipation is a subjective symptom that defines as inadequate defecation including several symptoms as follows: the sensation of incomplete bowel evacuation, hard stool, straining, and difficulty in defecation. The general prevalence of constipation in adults is 16%. The pre-defined risk factors are women gender, advanced age, non-white ethnicity, low socio-economic level, decreased physical activity underlying diseases, and medications. Chronic constipation affects quality of life and causes problems such as anxiety, depression, somatization, sleep disorders, sexual dysfunctions, school/work absenteeism. In the following periods, it causes serious comorbidities including dyspnea, gastro-esophageal reflux, hypertension, thyroid diseases, vaginitis, dyspareunia, diabetes, and fibromyalgia.
In the treatment of chronic constipation, conservative approaches (lifestyle change and physiotherapy applications) are used at the first phase. If conservative approaches are not helpful for patients pharmacological and surgical treatment can be performed based on the characteristics of patients, respectively. Pharmacological treatments aim to increase the frequency of spontaneous bowel movements, to reduce abdominal pain and swelling, and to improve stool consistency. However, side effects such as abdominal bloating, abdominal cramping, abdominal pain, stomach gas, nausea, diarrhea, headache and dyspnea are reported by patients in the following period. Furthermore, medications for constipation management are not cost-effective. Therefore, the level of evidence on conservative approaches with low cost, non-invasive and no-side effects in constipation treatment should be increased.
Physiotherapy approaches to alleviate chronic constipation symptoms include such as defecation training, abdominal massage, connective tissue massage, electrical stimulation, Kinesio-taping, anorectal biofeedback, and exercise training. Abdominal massage application in constipation is used in constipation management since the early 1870s and it is popular in recent years. The benefits of abdominal massage are known as follows: reduction in the abdominal muscle tension, improvement of local circulation, and stimulation of peristaltic movements. The technique of abdominal massage consists of 5 stages as follows: abdominal muscle stroking, colon stroking, colon kneading, colon stroking, and abdominal muscle stroking.
- Conditions
- Constipation
- Being tested
- Standard bowel management, Abdominal massage, Placebo Ultrasound
- Keywords
- massage, abdominal massage, chronic constipation, primary constipation, functional constipation, defecation
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard bowel managementOther
Lifestyle advices such as increasing fluid and fibre intake, improving physical activity level, and taking the ideal posture for defecation (squatting position) with a two-pages document.
Abdominal massageOther
Abdominal massage will be performed three days a week for four weeks. Each session will last around 15-20 minutes.
Placebo UltrasoundOther
Placebo ultrasound (US) will be applied to the abdominal region for four weeks, 2 days of the week and 15 minutes per day.
| Study group | Role | What they receive |
|---|---|---|
| Abdominal Massage | Experimental | Not described Receives: Other: Standard bowel management; Other: Abdominal massage |
| Placebo Ultrasound | Placebo comparator | Not described Receives: Other: Standard bowel management; Other: Placebo Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of constipation
Constipation Severity Instrument (CSI) will be used to evaluate the severity of the constipation. CSI was designed to evaluate defecation frequency and consistency as well as the level of straining experienced by individuals during bowel movement. There are three subscales of CSI, obstructive defecation (OT), colonic inertia (CI), and pain. Higher scores of CSI indicate more severe constipation.
Measured: Change in severity of constipation from baseline at 4 weeks
Secondary outcomes (6)
Patient Assessment of Constipation Quality of life
Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) will be used to evaluate quality of life. This questionnaire includes a total of 28 items in 4 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: Change in quality of life from baseline at 4 weeks
Stool consistency
The stool consistency will be evaluated using the Bristol Stool Scale (BSS), quick and useful indicator of the colonic transit time , a seven-point scale (from 1 to 7), type 1=separate hard lumps, like nuts; 2=sausage shaped but lumpy; 3=like a sausage or snake, but with cracks on its surface; 4=like a sausage or snake, smooth and soft; 5=soft blobs with clear cut edges; 6=pieces with ragged edges, a mushy stool; 7=water, no solid pieces. While type 1 and 2 indicate hard stool, type 3,4 and 5 show looser (ideal) stool.
Measured: Change from baseline stool consistency at 4 weeks
Symptoms of constipation
In order to gather information regarding the participants' symptoms of constipation, they will be asked to complete a 7-day bowel diary during the treatment period. This diary includes items regarding the frequency of bowel movement, stool consistency, defecation time, feeling of incomplete evacuation, and changes in food and liquid consumption.
Measured: Change from baseline symptoms of constipation at 4 weeks
Abdominal pain, abdominal bloating severity and the effect of life
Visual Analogue Scale (VAS): This scale is a 10 cm horizontal line. 0 = no pain / bloating / meaning no effect, 10 = unbearable pain / bloating / experiencing
Measured: Change from baseline symptoms of constipation at 4 weeks
Physical activity levels
The physical activity levels of the individuals in the last seven days are evaluated under 4 headings (severe activities, moderate activity, walking and sitting). While calculating the total score, the MET-min scores of the patients are obtained by multiplying the duration of activity and frequency of activities (number of days) by the BAT values given to activities (severe activity = 8 MET, moderate activity = 4 MET, walking = 3.3 MET)
Measured: Change from baseline symptoms of constipation at 4 weeks
Patient global change scale
It is a 7-item scale that evaluates the perception of the change in the effect of constipation and related complaints on the life of the patient compared to the study. The options on this scale are ''much much better'', ''much better'', 'a little better'', ''no change", ''a little worse'', ''much worse'', ''much much worse''
Measured: Change from baseline patient global change at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start10 Dec 2018
- Primary completion16 May 2019
- Study completion16 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SERAP ÖZGÜL, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03764995
- Sponsor's protocol ID
- 2018-261/2018-32
- Status last verified
- Oct 2021
- First submitted
- 3 Dec 2018
- Last updated
- 12 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lamas K, Lindholm L, Stenlund H, Engstrom B, Jacobsson C. Effects of abdominal massage in management of constipation--a randomized controlled trial. Int J Nurs Stud. 2009 Jun;46(6):759-67. doi: 10.1016/j.ijnurstu.2009.01.007. Epub 2009 Feb 12.
PubMed 19217105Sinclair M. The use of abdominal massage to treat chronic constipation. J Bodyw Mov Ther. 2011 Oct;15(4):436-45. doi: 10.1016/j.jbmt.2010.07.007. Epub 2010 Aug 25.
PubMed 21943617Lamas K, Graneheim UH, Jacobsson C. Experiences of abdominal massage for constipation. J Clin Nurs. 2012 Mar;21(5-6):757-65. doi: 10.1111/j.1365-2702.2011.03946.x. Epub 2011 Nov 21.
PubMed 22098585Dogan IG, Gursen C, Akbayrak T, Balaban YH, Vahabov C, Uzelpasaci E, Ozgul S. Abdominal Massage in Functional Chronic Constipation: A Randomized Placebo-Controlled Trial. Phys Ther. 2022 Jul 4;102(7):pzac058. doi: 10.1093/ptj/pzac058.
PubMed 35554601
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Abdominal Massage on Functional (Primary) Chronic Constipation
- ClinicalTrials.gov ID
- NCT03764995
- Acronym / sponsor ID
- 2018-261/2018-32
- Conditions
- Constipation
- Keywords
- massage, abdominal massage, chronic constipation, primary constipation, functional constipation, defecation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 16 May 2019 (actual)
- Study completion
- 16 May 2019 (actual)
- First posted
- 5 Dec 2018 (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.
The aim of the present study is to investigate the efficacy of abdominal massage in patients with functional (primary) chronic constipation. The present study is designed as a randomized placebo controlled. Since the placebo group is included in the research design, if there is a greater improvement of symptoms of constipation and quality of life in the massage group when compared to the control group, it will be determined that this effect is not related to a placebo effect. If the efficacy of Abdominal Massage is revealed with a placebo controlled design, the therapist effect will be eliminated and further evidence on a well-known massage technique in functional (primary) chronic constipation, a common gastrointestinal problem, will be provided. The results of the present placebo controlled randomized trial will indicate that the need for pharmacological agents and the side effects associated with these agents will be reduced. According to the literature, there are studies that investigate the effects of abdominal massage on symptoms of constipation and quality of life. However, it has generally been used for secondary constipation or two applications have been compared. In addition, there is no randomized placebo-controlled study investigating the effect of abdominal massage on severity of chronic constipation and quality of life.
Detailed description
Constipation is a subjective symptom that defines as inadequate defecation including several symptoms as follows: the sensation of incomplete bowel evacuation, hard stool, straining, and difficulty in defecation. The general prevalence of constipation in adults is 16%. The pre-defined risk factors are women gender, advanced age, non-white ethnicity, low socio-economic level, decreased physical activity underlying diseases, and medications. Chronic constipation affects quality of life and causes problems such as anxiety, depression, somatization, sleep disorders, sexual dysfunctions, school/work absenteeism. In the following periods, it causes serious comorbidities including dyspnea, gastro-esophageal reflux, hypertension, thyroid diseases, vaginitis, dyspareunia, diabetes, and fibromyalgia.
In the treatment of chronic constipation, conservative approaches (lifestyle change and physiotherapy applications) are used at the first phase. If conservative approaches are not helpful for patients pharmacological and surgical treatment can be performed based on the characteristics of patients, respectively. Pharmacological treatments aim to increase the frequency of spontaneous bowel movements, to reduce abdominal pain and swelling, and to improve stool consistency. However, side effects such as abdominal bloating, abdominal cramping, abdominal pain, stomach gas, nausea, diarrhea, headache and dyspnea are reported by patients in the following period. Furthermore, medications for constipation management are not cost-effective. Therefore, the level of evidence on conservative approaches with low cost, non-invasive and no-side effects in constipation treatment should be increased.
Physiotherapy approaches to alleviate chronic constipation symptoms include such as defecation training, abdominal massage, connective tissue massage, electrical stimulation, Kinesio-taping, anorectal biofeedback, and exercise training. Abdominal massage application in constipation is used in constipation management since the early 1870s and it is popular in recent years. The benefits of abdominal massage are known as follows: reduction in the abdominal muscle tension, improvement of local circulation, and stimulation of peristaltic movements. The technique of abdominal massage consists of 5 stages as follows: abdominal muscle stroking, colon stroking, colon kneading, colon stroking, and abdominal muscle stroking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abdominal Massage | Experimental | Other: Standard bowel management, Other: Abdominal massage |
| Placebo Ultrasound | Placebo comparator | Other: Standard bowel management, Other: Placebo Ultrasound |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 18 and 65 years.
- Diagnosed with chronic constipation according to Rome IV criteria
Key exclusion criteria (8 listed)
- A recent history of abdominal surgery
- Intestinal obstruction, ileus, colon cancer
- Enteric neuropathic patients: Diabetic intestinal neuropathy, Hirschsprung's disease, Megacolon, Megarectum
- Umbilical hernia
- Metabolic diseases: Cancer, Chronic renal failure, Severe cardiovascular disease, Hepatic failure, Hepatosplenomegaly, Abdominal aortic aneurysm
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 |
|---|---|---|
| Standard bowel managementLifestyle advices such as increasing fluid and fibre intake, improving physical activity level, and taking the ideal posture for defecation (squatting position) with a two-pages document. | Other | Abdominal Massage, Placebo Ultrasound |
| Abdominal massageAbdominal massage will be performed three days a week for four weeks. Each session will last around 15-20 minutes. | Other | Abdominal Massage |
| Placebo UltrasoundPlacebo ultrasound (US) will be applied to the abdominal region for four weeks, 2 days of the week and 15 minutes per day. | Other | Placebo Ultrasound |
Primary outcome
Severity of constipation
Time frame: Change in severity of constipation from baseline at 4 weeks
Constipation Severity Instrument (CSI) will be used to evaluate the severity of the constipation. CSI was designed to evaluate defecation frequency and consistency as well as the level of straining experienced by individuals during bowel movement. There are three subscales of CSI, obstructive defecation (OT), colonic inertia (CI), and pain. Higher scores of CSI indicate more severe constipation.
6 secondary outcomes
Patient Assessment of Constipation Quality of life
Time frame: Change in quality of life from baseline at 4 weeks
Stool consistency
Time frame: Change from baseline stool consistency at 4 weeks
Symptoms of constipation
Time frame: Change from baseline symptoms of constipation at 4 weeks
Abdominal pain, abdominal bloating severity and the effect of life
Time frame: Change from baseline symptoms of constipation at 4 weeks
Physical activity levels
Time frame: Change from baseline symptoms of constipation at 4 weeks
Patient global change scale
Time frame: Change from baseline patient global change at 4 weeks
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 12 Oct 2021.
- Background: PubMed 19217105Lamas K, Lindholm L, Stenlund H, Engstrom B, Jacobsson C. Effects of abdominal massage in management of constipation--a randomized controlled trial. Int J Nurs Stud. 2009 Jun;46(6):759-67. doi: 10.1016/j.ijnurstu.2009.01.007. Epub 2009 Feb 12.
- Background: PubMed 21943617Sinclair M. The use of abdominal massage to treat chronic constipation. J Bodyw Mov Ther. 2011 Oct;15(4):436-45. doi: 10.1016/j.jbmt.2010.07.007. Epub 2010 Aug 25.
- Background: PubMed 22098585Lamas K, Graneheim UH, Jacobsson C. Experiences of abdominal massage for constipation. J Clin Nurs. 2012 Mar;21(5-6):757-65. doi: 10.1111/j.1365-2702.2011.03946.x. Epub 2011 Nov 21.
- Derived from this study: PubMed 35554601Dogan IG, Gursen C, Akbayrak T, Balaban YH, Vahabov C, Uzelpasaci E, Ozgul S. Abdominal Massage in Functional Chronic Constipation: A Randomized Placebo-Controlled Trial. Phys Ther. 2022 Jul 4;102(7):pzac058. doi: 10.1093/ptj/pzac058.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard bowel management and Abdominal massage in people with Constipation, run by Hacettepe 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 2 inclusion and 8 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 12 Oct 2021. 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. Some participants in this study may receive a placebo. 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?
Severity of constipation (time frame: Change in severity of constipation from baseline at 4 weeks). 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 NCT03764995, which also lists 4 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 12 Oct 2021.