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The Effectiveness of Massage in Treating Constipation

Primary Purpose

Constipation

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
massage based on the tensegrity rule
massage - classical abdominal
Sponsored by
Wroclaw University of Health and Sport Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation focused on measuring constipation, massage, tensegrity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University School of Physical Education in Wrocław

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

tensegrity massage

classical massage

Arm Description

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

In this group of patients classical massage sessions were applied

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).

Full Information

First Posted
April 15, 2011
Last Updated
May 13, 2011
Sponsor
Wroclaw University of Health and Sport Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01354080
Brief Title
The Effectiveness of Massage in Treating Constipation
Official Title
Comparison of the Effectiveness of Massage Based on the Tensegrity Rule and Classical Abdominal Massage in Persons With Constipation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Wroclaw University of Health and Sport Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
constipation, massage, tensegrity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tensegrity massage
Arm Type
Experimental
Arm Description
In this group of patients massage sessions based on the tensegrity method were applied.
Arm Title
classical massage
Arm Type
Active Comparator
Arm Description
In this group of patients classical massage sessions were applied
Intervention Type
Other
Intervention Name(s)
massage based on the tensegrity rule
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
massage - classical abdominal
Intervention Description
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)
Primary Outcome Measure Information:
Title
Patient Questionnaire (including Rome Test)
Description
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
Time Frame
baseline (immediately before the first massage session)
Secondary Outcome Measure Information:
Title
Diary of Bowel Movements
Description
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).
Time Frame
on 7th day and 21st day from the 1st massage session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Krzysztof Kassolik, PhD
Organizational Affiliation
University School of Physical Education in Wrocław
Official's Role
Study Chair
Facility Information:
Facility Name
University School of Physical Education in Wrocław
City
Wrocław
State/Province
Wroclaw destrict
ZIP/Postal Code
51-612
Country
Poland

12. IPD Sharing Statement

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The Effectiveness of Massage in Treating Constipation

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