The Effects of Connective Tissue Manipulation and Abdominal Massage in Patients With Chronic Constipation

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02373488
• Date of registration: 23/02/2015
• Prospective Registration: No
• Primary sponsor: Hacettepe University
• Public title: The Effects of Connective Tissue Manipulation and Abdominal Massage in Patients With Chronic Constipation
• Date of first enrolment: November 2014
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02373488
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Turkey

Key inclusion & exclusion criteria

Inclusion Criteria:

- Participants will be recruited if they were over 18 years of age and had a diagnosis
of chronic constipation according to Rome III criteria. Rome III classification system
is widely use and standardized symptom-based diagnostic criteria for functional
gastrointestinal disorders, including chronic constipation. Rome III criteria include
that having at least 2 of the following: 1) straining; 2) lumpy and hard stool; 3)
sensation of incomplete evacuation; 4) sensation of anorectal obstruction/blockage; 5)
need for manual maneuvers 6) fewer than three defecation during = 25% defecations.
Also, symptoms should begin at least six months prior the diagnosis and they should be
seen intermittently or continuously for three months.

Exclusion Criteria:

- comorbid neurological, anatomical, or metabolic condition, pregnancy, mental problems
preventing cooperation, history of colostomy surgery, history of gastrointestinal,
spinal, or pelvic surgery except cholecystectomy, appendectomy, or hysterectomy,
comorbid various colonic conditions (intestinal obstruction, peritonitis, bowel
perforation, peptic ulcer, gastrointestinal bleeding, or acute inflammation of
abdominal organs), history of intestinal cancer, existence of open sore or tumor at
the massage region, and abdominal hernia.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Constipation

Intervention(s)

Other: connective tissue manipulation

Other: lifestyle advice

Other: abdominal massage

Primary Outcome(s)

severity of constipation [Time Frame: change from baseline severity of constipation at 4 weeks]

Secondary Outcome(s)

Stool consistency [Time Frame: change from baseline stool consistency at 4 weeks]

symptoms of constipation [Time Frame: change from baseline symptoms of constipation at 4 weeks]

Secondary ID(s)

GO 14/480

Source(s) of Monetary Support

Please refer to primary and secondary sponsors