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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01354080
Other study ID # 03constip2011KASS
Secondary ID
Status Completed
Phase N/A
First received April 15, 2011
Last updated May 13, 2011
Start date June 2007
Est. completion date March 2010

Study information

Verified date March 2010
Source University School of Physical Education in Wroclaw
Contact n/a
Is FDA regulated No
Health authority Poland: Ethics Committee
Study type Interventional

Clinical Trial 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.


Description:

Constipation can be defined as "an embarrassing ailment of the 21st century". It affects about 20-25% of the population, women as well as men, but occurs more frequently in women (female:male ratio of 2.2:1). Persons of different age suffer from it. Constipation is a bothersome ailment which negatively affects the general physical and mental state, lowers physical and mental fitness, significantly hinders professional work, and decreases life comfort As the factors which contribute to the occurrence of constipation are very diverse and complex, the treatment is a long-term and slow process. There are numerous conservative treatment methods for constipation, such as physical treatments, reflexotherapy, biofeedback, pharmacotherapy, and modification of lifestyle. There is also a possibility of applying classical massage in persons with constipation. However, observations of the authors suggest it is not a therapy commonly applied.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date March 2010
Est. primary completion date February 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

1. age from 18 to 70 years old

2. after therapy with Vermoks 2*1/ 3 regardless of body weight

3. negative Elis test for lambliasis

4. proper laboratory tests results: bilirubin, FA, GGTP, AspAT, AlAT

5. ultrasound scan of the abdominal cavity

6. positive interview based on questionnaire

Exclusion Criteria:

1. present cancer or prior cancer treatment, if there is no clear agreement of the involved oncologist

2. renal insufficiency > II NYHA

3. cardiovascular problems

4. respiratory insufficiency > II degree GOLD

5. unstable coronary disease

6. hypertensive crisis

7. liver insufficiency

8. prior liver transplant

9. prior or active hepatitis

10. jaundice

11. prior surgical treatments except: appendectomy >5 years before, cholecystectomy 5 years before

12. unequalized endocrinopathies

13. metabolic storage diseases

14. diabetes

15. nephrolithiasis

16. cholelithiasis

17. pancreatitis

18. chronic diseases of the intestines

19. diseases of the muscles

20. pregnancy

21. parasite infections of the digestive system (infection with human roundworm, lambliasis)

22. age above 18 years old

23. BMI> 33

24. improper ultrasound scan result or laboratory tests results

25. blood presence in feces

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
massage based on the tensegrity rule
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.
massage - classical abdominal
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)

Locations

Country Name City State
Poland University School of Physical Education in Wroclaw Wroclaw Wroclaw destrict

Sponsors (1)

Lead Sponsor Collaborator
University School of Physical Education in Wroclaw

Country where clinical trial is conducted

Poland, 

References & Publications (16)

Ayas S, Leblebici B, Sözay 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. — View Citation

Bharucha AE. Constipation. Best Pract Res Clin Gastroenterol. 2007;21(4):709-31. Review. — View Citation

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. Epub 2007 Ju — View Citation

Emly M. Abdominal massage. Nurs Times. 1993 Jan 20-26;89(3):34-6. — View Citation

Harrington KL, Haskvitz EM. Managing a patient's constipation with physical therapy. Phys Ther. 2006 Nov;86(11):1511-9. — View Citation

Ingber DE. The architecture of life. Sci Am. 1998 Jan;278(1):48-57. — View Citation

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. Review. — View Citation

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

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

Kassolik K, Jaskólska A, Kisiel-Sajewicz K, Marusiak J, Kawczynski A, Jaskólski 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. — View Citation

Klauser AG, Flaschenträger J, Gehrke A, Müller-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. — View Citation

Lacy BE. Defining and treating constipation in older adults. Am Fam Physician. 2006 Sep 1;74(5):715-6; author reply 716. — View Citation

Lämås K, Lindholm L, Stenlund H, Engström 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. — View Citation

Leung FW. Etiologic factors of chronic constipation: review of the scientific evidence. Dig Dis Sci. 2007 Feb;52(2):313-6. Epub 2007 Jan 12. Review. — View Citation

Stark ME. Challenging problems presenting as constipation. Am J Gastroenterol. 1999 Mar;94(3):567-74. Review. — View Citation

Tariq SH. Constipation in long-term care. J Am Med Dir Assoc. 2007 May;8(4):209-18. Review. — View Citation

* Note: There are 16 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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) No
Secondary Diary of Bowel Movements The aims of the Diary were to supply documentary evidence of the frequency and the quality of bowel movements, and to compare them with the state from before the experiment (the Patient Questionnaire). on 7th day and 21st day from the 1st massage session No
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