Clinical trial NCT02373488: The Effects of Connective Tissue Manipulation and Abdominal Massage in Patients With Chronic Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Keywords: Constipation
connective tissue manipulation
abdominal massage
bowel movements
quality of life
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2015-02-27
Enrollment: 60
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: The aim of this study is to investigate the effect of connective tissue manipulation and abdominal massage on severity of constipation and health related quality of life in patients with chronic constipation. According to literature, there are studies that investigate the effects of abdominal massage on bowel movements. But there is no randomized controlled trial, explore the short and long-term effects of different massage technics on chronic constipation. Hypothesis of this study is that connective tissue manipulation and abdominal massage improves symptoms of constipation and health related quality of life in patients suffering with constipation.

Detailed description: Chronic constipation is not a disease but a symptom of a condition involving insufficient defecation and whose definition varies from person to person. Health professionals define constipation as 3 times or less per week defecation and the patients define it as the sensation of incomplete bowel evacuation, hard stool, straining, and difficulty in defecation. Chronic constipation is a common condition experienced by the general public, and it reduces the health related quality of life (HRQOL) by negatively affecting the physical, mental, and social well being of individuals. In a recent meta-analysis, the global prevalence rate of chronic constipation was reported to be 14%; it was also reported that its incidence rate is correlated with increasing age and low-income level, and it is more common among females.

Because the underlying pathophysiology of chronic constipation has not been clearly identified, its treatment has been difficult for both healthcare professionals and patients. Following the elimination of pathological and secondary causes, the treatment of chronic constipation is initiated by non-pharmacological treatment methods, such as lifestyle modifications (increased dietary fiber and water intake as well as increased physical activity), defecation training, and physiotherapy approaches. If lifestyle modification and conservative treatment methods do not help the patient, pharmacological treatment methods, such as osmotic laxatives, stimulant laxatives, stool softeners, lubricants, chloride channel activators, and serotonin agents, may be used. At the final stage, if the pharmacological treatment is not successful in patients with slow-transit constipation, surgical treatment options, such as segmental, subtotal, or total colectomy, are considered. Conservative treatment methods used in patients with chronic constipation may include abdominal massage, connective tissue manipulation (CTM), chiropractic treatment, electrical stimulation, anorectal biofeedback and exercise.

CTM, one of the conservative treatment methods for chronic constipation, generates local mechanical effects on mast cells in the connective tissue by short and long tractions and thus creates vasodilation by reducing the sympathetic activity. Subsequently, parasympathetic effect increases and the improvement in the circulation promotes healing process. But there is very little research that examine its effectiveness on constipation and bowel function. In the case report of Holey et al., it was reported that CTM was better than abdominal massage in improving symptoms of constipation. Also, another study revealed that combination of pelvic exercises and CTM played a role in healing bowel functions in women immediately after the post cesarean delivery.

Abdominal massage is another treatment approach using the management of chronic constipation. The benefits of physiotherapy in treatment of constipation include mechanical and neurological effects. Mechanical effects include accelerating colonic motility, improving colonic transit time, coordinating the muscles and increasing abdominal muscle tone. The neurological effect is to enhance the activity of the parasympathetic nervous system.

Eligibility criteria: Inclusion Criteria:

* Participants will be recruited if they were over 18 years of age and had a diagnosis of chronic constipation according to Rome III criteria. Rome III classification system is widely use and standardized symptom-based diagnostic criteria for functional gastrointestinal disorders, including chronic constipation. Rome III criteria include that having at least 2 of the following: 1) straining; 2) lumpy and hard stool; 3) sensation of incomplete evacuation; 4) sensation of anorectal obstruction/blockage; 5) need for manual maneuvers 6) fewer than three defecation during ≥ 25% defecations. Also, symptoms should begin at least six months prior the diagnosis and they should be seen intermittently or continuously for three months.

Exclusion Criteria:

* comorbid neurological, anatomical, or metabolic condition, pregnancy, mental problems preventing cooperation, history of colostomy surgery, history of gastrointestinal, spinal, or pelvic surgery except cholecystectomy, appendectomy, or hysterectomy, comorbid various colonic conditions (intestinal obstruction, peritonitis, bowel perforation, peptic ulcer, gastrointestinal bleeding, or acute inflammation of abdominal organs), history of intestinal cancer, existence of open sore or tumor at the massage region, and abdominal hernia.

Primary outcomes:
measure: severity of constipation
timeFrame: change from baseline severity of constipation at 4 weeks
Secondary outcomes:
measure: Stool consistency
timeFrame: change from baseline stool consistency at 4 weeks
measure: symptoms of constipation
timeFrame: change from baseline symptoms of constipation at 4 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
citation: 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.
citation: Sinclair 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.
citation: Holey LA, Dixon J, Selfe J. An exploratory thermographic investigation of the effects of connective tissue massage on autonomic function. J Manipulative Physiol Ther. 2011 Sep;34(7):457-62. doi: 10.1016/j.jmpt.2011.05.012. Epub 2011 Jul 23.
citation: Holey LA, Dixon J. Connective tissue manipulation: a review of theory and clinical evidence. J Bodyw Mov Ther. 2014 Jan;18(1):112-8. doi: 10.1016/j.jbmt.2013.08.003. Epub 2013 Sep 8.