The Effects of Connective Tissue Manipulation and Abdominal Massage in Patients With Chronic Constipation

NCT02373488 | Completed

• 1 other identifier: GO 14/480
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation

Keywords

Constipation; connective tissue manipulation; abdominal massage; bowel movements; quality of life

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 from baseline severity of constipation at 4 weeks

Secondary Outcomes (2)

• Stool consistency

  change from baseline stool consistency at 4 weeks

• symptoms of constipation

  change from baseline symptoms of constipation at 4 weeks

Study Arms (3)

control

OTHER

lifestyle advice

Other: lifestyle advice

intervention-1

ACTIVE COMPARATOR

connective tissue manipulation

Other: lifestyle advice; Other: connective tissue manipulation

intervention-2

ACTIVE COMPARATOR

abdominal massage

Other: lifestyle advice; Other: abdominal massage

Interventions

lifestyle advice 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.

control; intervention-1; intervention-2

connective tissue manipulation OTHER

CTM wil be applied five days per week, a total of 20 sessions for 4 weeks. Each session lasted around 15-20 minutes. While patients are in a sitting position, starting from the lumbosacral region, lower thoracic, scapular, inter-scapular and cervical regions will be included in the treatment, respectively.

intervention-1

abdominal massage OTHER

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

intervention-2

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

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

• 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.

  PMID: 21875520 BACKGROUND

• 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.

  PMID: 24411158 BACKGROUND

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: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: February 23, 2015
• First Posted: February 27, 2015
• Study Start: November 1, 2014
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: October 9, 2018

Record last verified: 2018-10

Locations

TU (1)