NCT01354080

Brief Summary

The purpose of this study is to compare the effectiveness of massage based on the tensegrity rule and classical abdominal massage in persons with constipation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 15, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 16, 2011

Completed
Last Updated

May 16, 2011

Status Verified

March 1, 2010

Enrollment Period

2.7 years

First QC Date

April 15, 2011

Last Update Submit

May 13, 2011

Conditions

Keywords

constipationmassagetensegrity

Outcome Measures

Primary Outcomes (1)

  • Patient Questionnaire (including Rome Test)

    The aims of the Patient Questionnaire were to proof constipation presence and supply evidence of the frequency and the quality of bowel movements, and to compare them with the state from Diary

    baseline (immediately before the first massage session)

Secondary Outcomes (1)

  • Diary of Bowel Movements

    on 7th day and 21st day from the 1st massage session

Study Arms (2)

tensegrity massage

EXPERIMENTAL

In this group of patients massage sessions based on the tensegrity method were applied.

Other: massage based on the tensegrity rule

classical massage

ACTIVE COMPARATOR

In this group of patients classical massage sessions were applied

Other: massage - classical abdominal

Interventions

The massage consist of brushing the skin, stroking of the lower abdominal integuments. Elastic deformation of the thoracolumbar fascia. Then the abdominal integuments were elastically deformed by kneading to normalize the rest tension of the muscles of the abdominal integuments as well as, indirectly, the myofascial apparatus of the pelvic floor and in this way improve venous blood and lymph outflow from the large intestine and the sigmoid colon area. The next treatment stage - performing circular movements within the limits of the skin's mobility at 1/3 of the medial part of the thigh. By stroking movements in the direction of the armpit in accordance with the run of the thoracoepigastric and costalaxillary veins. Then the intercostal muscles were deformed.

tensegrity massage

The classical abdominal massage consisted of circular movements performed on the abdominal integuments by superficial and deep stroking techniques according to the colonic route (clockwise)

classical massage

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age from 18 to 70 years old
  • after therapy with Vermoks 2\*1/ 3 regardless of body weight
  • negative Elis test for lambliasis
  • proper laboratory tests results: bilirubin, FA, GGTP, AspAT, AlAT
  • ultrasound scan of the abdominal cavity
  • positive interview based on questionnaire

You may not qualify if:

  • present cancer or prior cancer treatment, if there is no clear agreement of the involved oncologist
  • renal insufficiency \> II NYHA
  • cardiovascular problems
  • respiratory insufficiency \> II degree GOLD
  • unstable coronary disease
  • hypertensive crisis
  • liver insufficiency
  • prior liver transplant
  • prior or active hepatitis
  • jaundice
  • prior surgical treatments except: appendectomy \>5 years before, cholecystectomy 5 years before
  • unequalized endocrinopathies
  • metabolic storage diseases
  • diabetes
  • nephrolithiasis
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University School of Physical Education in Wrocław

Wroclaw, Wroclaw Destrict, 51-612, Poland

Location

Related Publications (16)

  • Ingber DE. The architecture of life. Sci Am. 1998 Jan;278(1):48-57. doi: 10.1038/scientificamerican0198-48.

    PMID: 11536845BACKGROUND
  • Kalish VB, Loven B, Sehgal M. Clinical inquiries. What is the best treatment for chronic constipation in the elderly? J Fam Pract. 2007 Dec;56(12):1050-2. No abstract available.

    PMID: 18053448BACKGROUND
  • Kassolik K, Andrzejewski W, Trzęsicka E, Charlton G. Anatomical Grounds for the Use of the Tensegrity Principle in Massage. Fizjoterapia Polska 3(4) vol. 7: 332-343, 2007.

    BACKGROUND
  • 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: 19217105BACKGROUND
  • Leung FW. Etiologic factors of chronic constipation: review of the scientific evidence. Dig Dis Sci. 2007 Feb;52(2):313-6. doi: 10.1007/s10620-006-9298-7. Epub 2007 Jan 12.

    PMID: 17219073BACKGROUND
  • Stark ME. Challenging problems presenting as constipation. Am J Gastroenterol. 1999 Mar;94(3):567-74. doi: 10.1111/j.1572-0241.1999.00917.x.

    PMID: 10086634BACKGROUND
  • Tariq SH. Constipation in long-term care. J Am Med Dir Assoc. 2007 May;8(4):209-18. doi: 10.1016/j.jamda.2007.02.009.

    PMID: 17498603BACKGROUND
  • Ayas S, Leblebici B, Sozay S, Bayramoglu M, Niron EA. The effect of abdominal massage on bowel function in patients with spinal cord injury. Am J Phys Med Rehabil. 2006 Dec;85(12):951-5. doi: 10.1097/01.phm.0000247649.00219.c0.

  • Lacy BE. Defining and treating constipation in older adults. Am Fam Physician. 2006 Sep 1;74(5):715-6; author reply 716. No abstract available.

  • Bharucha AE. Constipation. Best Pract Res Clin Gastroenterol. 2007;21(4):709-31. doi: 10.1016/j.bpg.2007.07.001.

  • Chitkara DK, Talley NJ, Locke GR 3rd, Weaver AL, Katusic SK, De Schepper H, Rucker MJ. Medical presentation of constipation from childhood to early adulthood: a population-based cohort study. Clin Gastroenterol Hepatol. 2007 Sep;5(9):1059-64. doi: 10.1016/j.cgh.2007.04.028. Epub 2007 Jul 13.

  • Emly M. Abdominal massage. Nurs Times. 1993 Jan 20-26;89(3):34-6. No abstract available.

  • Harrington KL, Haskvitz EM. Managing a patient's constipation with physical therapy. Phys Ther. 2006 Nov;86(11):1511-9. doi: 10.2522/ptj.20050347.

  • Kassolik K, Andrzejewski W, Trzęsicka E. Role of the Tensegrity Rule in Theoretical Basis of Massage Therapy. Journal of Back and Musculoskeletal Rehabilitation 20(1):1053-8127, 2007.

    RESULT
  • Kassolik K, Jaskolska A, Kisiel-Sajewicz K, Marusiak J, Kawczynski A, Jaskolski A. Tensegrity principle in massage demonstrated by electro- and mechanomyography. J Bodyw Mov Ther. 2009 Apr;13(2):164-70. doi: 10.1016/j.jbmt.2007.11.002. Epub 2007 Dec 21.

  • Klauser AG, Flaschentrager J, Gehrke A, Muller-Lissner SA. Abdominal wall massage: effect on colonic function in healthy volunteers and in patients with chronic constipation. Z Gastroenterol. 1992 Apr;30(4):247-51.

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Krzysztof Kassolik, PhD

    University School of Physical Education in Wrocław

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 15, 2011

First Posted

May 16, 2011

Study Start

June 1, 2007

Primary Completion

February 1, 2010

Study Completion

March 1, 2010

Last Updated

May 16, 2011

Record last verified: 2010-03

Locations