- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01354080
The Effectiveness of Massage in Treating Constipation
May 13, 2011 updated by: University School of Physical Education in Wroclaw
Comparison of the Effectiveness of Massage Based on the Tensegrity Rule and Classical Abdominal Massage in Persons With Constipation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Wroclaw destrict
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Wrocław, Wroclaw destrict, Poland, 51-612
- University School of Physical Education in Wrocław
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 66 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- cholelithiasis
- pancreatitis
- chronic diseases of the intestines
- diseases of the muscles
- pregnancy
- parasite infections of the digestive system (infection with human roundworm, lambliasis)
- age above 18 years old
- BMI> 33
- improper ultrasound scan result or laboratory tests results
- blood presence in feces
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: tensegrity massage
In this group of patients massage sessions based on the tensegrity method were applied.
|
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.
|
|
Active Comparator: classical massage
In this group of patients classical massage sessions were applied
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Questionnaire (including Rome Test)
Time Frame: baseline (immediately before the first massage session)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diary of Bowel Movements
Time Frame: on 7th day and 21st day from the 1st massage session
|
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).
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on 7th day and 21st day from the 1st massage session
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Krzysztof Kassolik, PhD, University School of Physical Education in Wrocław
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Ingber DE. The architecture of life. Sci Am. 1998 Jan;278(1):48-57. doi: 10.1038/scientificamerican0198-48.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
February 1, 2010
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
April 15, 2011
First Submitted That Met QC Criteria
May 13, 2011
First Posted (Estimate)
May 16, 2011
Study Record Updates
Last Update Posted (Estimate)
May 16, 2011
Last Update Submitted That Met QC Criteria
May 13, 2011
Last Verified
March 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03constip2011KASS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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