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The Effects of Abdominal Massage on Functional (Primary) Chronic Constipation

H

Hacettepe University

Status

Completed

Conditions

Constipation

Treatments

Other: Abdominal massage
Other: Standard bowel management
Other: Placebo Ultrasound

Study type

Interventional

Funder types

Other

Identifiers

NCT03764995
2018-261/2018-32

Details and patient eligibility

About

The aim of the present study is to investigate the efficacy of abdominal massage in patients with functional (primary) chronic constipation. The present study is designed as a randomized placebo controlled. Since the placebo group is included in the research design, if there is a greater improvement of symptoms of constipation and quality of life in the massage group when compared to the control group, it will be determined that this effect is not related to a placebo effect. If the efficacy of Abdominal Massage is revealed with a placebo controlled design, the therapist effect will be eliminated and further evidence on a well-known massage technique in functional (primary) chronic constipation, a common gastrointestinal problem, will be provided. The results of the present placebo controlled randomized trial will indicate that the need for pharmacological agents and the side effects associated with these agents will be reduced. According to the literature, there are studies that investigate the effects of abdominal massage on symptoms of constipation and quality of life. However, it has generally been used for secondary constipation or two applications have been compared. In addition, there is no randomized placebo-controlled study investigating the effect of abdominal massage on severity of chronic constipation and quality of life.

Full description

Constipation is a subjective symptom that defines as inadequate defecation including several symptoms as follows: the sensation of incomplete bowel evacuation, hard stool, straining, and difficulty in defecation. The general prevalence of constipation in adults is 16%. The pre-defined risk factors are women gender, advanced age, non-white ethnicity, low socio-economic level, decreased physical activity underlying diseases, and medications. Chronic constipation affects quality of life and causes problems such as anxiety, depression, somatization, sleep disorders, sexual dysfunctions, school/work absenteeism. In the following periods, it causes serious comorbidities including dyspnea, gastro-esophageal reflux, hypertension, thyroid diseases, vaginitis, dyspareunia, diabetes, and fibromyalgia.

In the treatment of chronic constipation, conservative approaches (lifestyle change and physiotherapy applications) are used at the first phase. If conservative approaches are not helpful for patients pharmacological and surgical treatment can be performed based on the characteristics of patients, respectively. Pharmacological treatments aim to increase the frequency of spontaneous bowel movements, to reduce abdominal pain and swelling, and to improve stool consistency. However, side effects such as abdominal bloating, abdominal cramping, abdominal pain, stomach gas, nausea, diarrhea, headache and dyspnea are reported by patients in the following period. Furthermore, medications for constipation management are not cost-effective. Therefore, the level of evidence on conservative approaches with low cost, non-invasive and no-side effects in constipation treatment should be increased.

Physiotherapy approaches to alleviate chronic constipation symptoms include such as defecation training, abdominal massage, connective tissue massage, electrical stimulation, Kinesio-taping, anorectal biofeedback, and exercise training. Abdominal massage application in constipation is used in constipation management since the early 1870s and it is popular in recent years. The benefits of abdominal massage are known as follows: reduction in the abdominal muscle tension, improvement of local circulation, and stimulation of peristaltic movements. The technique of abdominal massage consists of 5 stages as follows: abdominal muscle stroking, colon stroking, colon kneading, colon stroking, and abdominal muscle stroking.

Enrollment

74 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age between 18 and 65 years.
  • Diagnosed with chronic constipation according to Rome IV criteria

Exclusion criteria

  • A recent history of abdominal surgery
  • Intestinal obstruction, ileus, colon cancer
  • Enteric neuropathic patients: Diabetic intestinal neuropathy, Hirschsprung's disease, Megacolon, Megarectum
  • Umbilical hernia
  • Metabolic diseases: Cancer, Chronic renal failure, Severe cardiovascular disease, Hepatic failure, Hepatosplenomegaly, Abdominal aortic aneurysm
  • Neurological diseases: Parkinson, Spinal cord injury, Multiple sclerosis, Cerebro-vascular event,
  • Paraplegia Mental problem to prevent co-operative treatment
  • Pregnancy and lactation

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

74 participants in 2 patient groups, including a placebo group

Abdominal Massage
Experimental group
Treatment:
Other: Standard bowel management
Other: Abdominal massage
Placebo Ultrasound
Placebo Comparator group
Treatment:
Other: Standard bowel management
Other: Placebo Ultrasound

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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