The Effects of Abdominal Massage on Functional (Primary) Chronic Constipation

NCT03764995 | Completed

• 1 other identifier: 2018-261/2018-32
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Constipation

Keywords

massage; abdominal massage; chronic constipation; primary constipation; functional constipation; defecation

Outcome Measures

Primary Outcomes (1)

• 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.

  Change in severity of constipation from baseline at 4 weeks

Secondary Outcomes (6)

• Patient Assessment of Constipation Quality of life

  Change in quality of life from baseline at 4 weeks

• Stool consistency

  Change from baseline stool consistency at 4 weeks

• Symptoms of constipation

  Change from baseline symptoms of constipation at 4 weeks

• Abdominal pain, abdominal bloating severity and the effect of life

  Change from baseline symptoms of constipation at 4 weeks

• Physical activity levels

  Change from baseline symptoms of constipation at 4 weeks

Study Arms (2)

Abdominal Massage

EXPERIMENTAL

Other: Standard bowel management; Other: Abdominal massage

Placebo Ultrasound

PLACEBO COMPARATOR

Other: Standard bowel management; Other: Placebo Ultrasound

Interventions

Standard bowel management OTHER

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 Massage; Placebo Ultrasound

Abdominal massage OTHER

Abdominal massage will be performed three days a week for four weeks. Each session will last around 15-20 minutes.

Abdominal Massage

Placebo Ultrasound OTHER

Placebo ultrasound (US) will be applied to the abdominal region for four weeks, 2 days of the week and 15 minutes per day.

Placebo Ultrasound

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65 years.
• Diagnosed with chronic constipation according to Rome IV criteria

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Ceren Gursen

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 19217105 BACKGROUND

• 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.

  PMID: 21943617 BACKGROUND

• Lamas 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.

  PMID: 22098585 BACKGROUND

• Dogan 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.

  PMID: 35554601 DERIVED

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doc. Dr.

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 5, 2018
• Study Start: December 10, 2018
• Primary Completion: May 16, 2019
• Study Completion: May 16, 2019
• Last Updated: October 12, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)