Connective Tissue Manipulation Improves Symptoms and Quality of Life in Patients With Chronic Constipation

NCT02321124 | Completed

• 1 other identifier: Hacettepe University
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Connective tissue manipulation (CTM) is a manual reflex therapy, which increases intestinal motility by stimulating autonomic nervous system to re-balance the parasympathetic and sympathetic functions. However, there is no randomized controlled trial (RCT) regarding the efficacy of CTM on constipation. This study was planned to investigate the effects of CTM in patients with chronic constipation. Patients who have diagnosis of chronic constipation according to Rome III criteria were recruited and randomized to intervention and control group. The intervention group received CTM in addition to the lifestyle advice, while the control group was given only lifestyle advice for constipation. All assessments were performed at baseline and at the end of 4 weeks. The primary outcome measure was the Constipation Severity Instrument (CSI). Secondary outcomes included Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL), Bristol Stool Scale (BSS) and 7-day bowel diary. Differences between groups were analyzed with t-tests, Mann-Whitney U test and Chi-square test.

Conditions

Chronic Constipation

Keywords

Constipation; connective tissue manipulation; conservative therapy; massage; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Constipation Severity Instrument (CSI)

  Constipation Severity Instrument was designed to evaluate individuals' 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.

  Participants will be followed for four weeks. Change from baseline severity of constipation at 4 weeks will be evaluated.

Secondary Outcomes (5)

• Patient-Assessment of Quality of Life Questionnaire (PAC-QOL)

  Participants will be followed for four weeks. Change from baseline quality of life at 4 weeks will be assessed.

• Bristol Stool Scale

  Participants will be followed for four weeks. Change from baseline stool consistency at 4 weeks will be assessed.

• 7-day bowel diary

  Participants will be followed for four weeks. Change from baseline symptoms of constipation at 4 weeks will be evaluated.

• perception of subjective change

  Participants will be followed for four weeks. Change of subjective change from baseline after 4 week treatment will be assessed.

• compliance with advice

  Participants will be followed for four weeks. Change of compliance with advice from baseline after 4 week treatment will be assessed.

Study Arms (2)

intervention

ACTIVE COMPARATOR

we will apply connective tissue manipulation and life style advice.

Other: connective tissue manipulation; Behavioral: life style advice

control group

OTHER

We will apply only life style advice.

Behavioral: life style advice

Interventions

connective tissue manipulation OTHER

We will apply connective tissue manipulation 5 days a week for four weeks.

intervention

life style advice BEHAVIORAL

We will apply life style advice for four weeks.

control group; intervention

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 were recruited if they were over 18 years of age and had a diagnosis of chronic constipation according to Rome III criteria.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (4)

• Holey EA, Lawler HL. The effects of classical massage and connective tissue manipulation on bowel function. Br J Ther Rehabil 1995;211:627-31.

  BACKGROUND

• Quist DM, Duray SM. Resolution of symptoms of chronic constipation in an 8-year-old male after chiropractic treatment. J Manipulative Physiol Ther. 2007 Jan;30(1):65-8. doi: 10.1016/j.jmpt.2006.11.005.

  PMID: 17224358 BACKGROUND

• Simmons SF, Schnelle JF. Effects of an exercise and scheduled-toileting intervention on appetite and constipation in nursing home residents. J Nutr Health Aging. 2004;8(2):116-21.

  PMID: 14978607 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

Related Links

• rome foundation

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

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

Study Officials

• Ceren Gursen

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Mintaze Kerem Gunel

  Hacettepe University

  STUDY DIRECTOR

• Serap Kaya

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Taylan Kav

  Hacettepe University

  STUDY DIRECTOR

• Türkan Akbayrak

  Hacettepe University

  STUDY CHAIR

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: Research Assistant

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: December 22, 2014
• Study Start: August 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 9, 2018

Record last verified: 2018-10

Locations

TU (1)