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NCT Number: NCT07719504

Implementation of Physical Therapy Protocol for Functional Constipation

The goal of this randomized controlled trial is to investigate the effects of standard medical treatment alone and the effects of adding different physiotherapy protocols to standard medical treatment on constipation severity, abdominal circumference, and quality of life in adults with functional constipation.

Researchers will compare four groups to investigate the effects of standard medical treatment alone and the effects of adding different physiotherapy protocols to standard medical treatment. The physiotherapy protocols will include maitland orthopedic manual therapy, electrical russian stimulation, osteopathic visceral manipulation, passive peristalsis motion techniques, and a home program including isometric abdominal muscle exercises and hot packs.

Participants will be randomly assigned to one of four groups. The control group will receive standard medical treatment alone. The three intervention groups will receive standard medical treatment combined with different physiotherapy protocols. The treatment program will last six weeks. Constipation severity and quality of life will be assessed at baseline, after the first two weeks, after the second two-week period, and after the final two weeks. Abdominal circumference will be measured before the start of treatment and after completion of the intervention

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Key information

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Functional constipation is a common gastrointestinal disorder characterized by infrequent bowel movements, straining during defecation, and hard or lumpy stools. Despite the use of pharmacological treatments, some patients continue to experience persistent symptoms and reduced quality of life. Previous studies have investigated individual physiotherapy techniques, including manual therapy, visceral manipulation, and electrical stimulation, but limited evidence is available regarding the combined effects of different physiotherapy approaches alongside standard medical treatment in adults with functional constipation.

This study will be conducted as a randomized controlled trial with a pre-test and post-test design. Sixty adults aged 20 to 40 years with functional constipation will be randomly allocated into four equal groups of 15 participants. The study will compare standard medical treatment alone with different combinations of physiotherapy interventions added to standard medical treatment.

The study will investigate whether the addition of different physiotherapy protocols to standard medical treatment can improve constipation severity, constipation-related quality of life, and abdominal circumference. The treatment program will be conducted over a six-week period, and the outcomes will be assessed according to the predefined assessment schedule.

The findings of this study may help clarify the effects of combining different physiotherapy approaches with standard medical treatment and may contribute to the development of more comprehensive physiotherapy management strategies for adults with functional constipation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients had functional constipation.
  • All patients will be diagnosed and referred by physicians.
  • Their ages will range from 20 to 40 years old .
  • Both genders will be in study.
  • Patients with low physical activity or sedentary life
  • All understand the purpose of the session

Exclusion criteria

  • Pregnancy.
  • Recent abdominal surgery.
  • Patients with acute ischemic bowel disease.
  • Intestinal obstruction.
  • Patients with Celiac Disease.
  • Patients with Crohn's disease.
  • Endocrine and metabolic causes of chronic constipation.
  • Neurological causes of chronic constipation.

Treatment and study plan

Standard Medical Treatment

Drug

Participants will receive standard medical treatment for functional constipation as prescribed and managed by an internal medicine physician according to the participant's clinical condition. The specific medication, dosage, and duration will be determined by the treating physician.

Maitland orthopedic manual therapy (MOMT)

Procedure

Maitland orthopedic manual therapy will be applied to the T9-L2 spinal segments using facet joint mobilization techniques, corresponding to the gastrointestinal tract. Mobilization will be performed at a frequency of 2-3 oscillations per second, with 3-4 mobilizations applied to each joint. Each mobilization will last approximately 30 seconds, with a 1-minute rest interval between mobilizations. The intervention will be administered three sessions per week for six weeks.

Russian current stimulation (ERS)

Device

Russian current stimulation will be applied to the abdominal muscles for 10 minutes in the supine lying position. The stimulation will be delivered in repeated cycles of 10 seconds of stimulation followed by 50 seconds of rest throughout the 10-minute treatment period. Four electrodes will be placed over the abdominal muscles, including the rectus abdominis and transversus abdominis muscles: two electrodes above the umbilicus and two below the umbilicus, positioned paramedian to the umbilicus. The stimulation intensity will be adjusted according to the participant's tolerance. The intervention will be administered three sessions per week for six weeks.

Passive peristalsis motion techniques

Procedure

Passive peristalsis motion techniques will be performed using a Swedish technique combining abdominal and colonic massage. Participants will be positioned supine, with thin pillows under the head and knees. Massage oil will be used to reduce friction. The technique will be performed in five phases, with three repetitions: abdominal stroking, colon stroking, colon kneading using deep circular/frictional movements at seven points approximately 5 cm apart along the descending, transverse, and ascending colon, followed by colon stroking and abdominal stroking. Light-to-medium pressure will be used for abdominal stroking, while firm pressure will be applied during colon stroking and kneading. Colon strokes will be performed clockwise, following the direction of the colon. Treatment will be provided three times weekly, with each session lasting approximately 10 minutes, for six weeks.

Osteopathic visceral manipulation (OVM)

Procedure

Osteopathic visceral manipulation (OVM) will be performed with participants in a hook-lying position, with the head supported by a pillow to reduce tension on the abdominal wall. A physiotherapist will apply OVM to eight abdominal sites: the cardia, pylorus, sphincter of Oddi, duodenojejunal valve, ileocecal valve, sigmoid colon, liver (global manipulation), and global hemodynamic manipulation. Each of the first six techniques will be performed for 1 minute. The last two techniques will be performed 10 times each in association with respiratory inspiration and expiration. Deep pressure will be applied using the lower palm over the targeted sites. OVM will be administered once weekly for six weeks.

Isometric abdominal muscle exercises (IAME)

Behavioral

Participants will perform the exercises at home as part of the home program. The participant will lie supine with the hips and knees flexed to 90°. Training will begin with two sets of eight contractions and relaxations, continuing until the end of the third week. From the fourth week onward, the protocol will progress to two sets of 12 contractions and relaxations. The exercise will be considered successful when protrusion of the lower abdomen is observed, indicating simultaneous relaxation of the lower abdominal muscles and pelvic floor.

Hot pack application

Device

Participants will apply a hot pack at home as part of the home program for six weeks. The hot pack will be wrapped in a cotton towel and applied to the abdominal region for 10-15 minutes per session.

Primary outcomes

  1. Constipation Severity

    Time frame: Baseline (pre-test), after the first 2 weeks of intervention, after the second 2-week period, and after the final 2 weeks at the end of the 6-week treatment program (post-test).

    Constipation severity will be assessed using the Constipation Scoring System (CSS), also known as the Cleveland Clinic Constipation Score. The CSS assesses constipation severity on a 0-30 point scale, with higher scores indicating greater constipation severity.

Secondary outcomes

  1. Constipation-Related Quality of Life

    Time frame: The PAC-QOL will be assessed at baseline, after the first 2 weeks of intervention, after the second 2-week period, and after the final 2 weeks at the end of the 6-week treatment program.

    Constipation-related quality of life will be assessed using the Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL). The Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) consists of 28 items rated on a five-point Likert scale ranging from 0 to 4. It assesses four subscales: physical discomfort, psychosocial discomfort, worries and concerns, and satisfaction. Higher scores indicate worse quality of life in the physical discomfort, psychosocial discomfort, and worries and concerns subscales. The total score for these subscales ranges from 0 to 96. The satisfaction subscale is reverse-coded, with scores ranging from 0 to 16, where higher scores indicate greater satisfaction and better quality of life.

  2. Abdominal Circumference

    Time frame: Baseline (pre-test) and after completion of the 6-week intervention (post-test).

    Abdominal circumference will be measured using a non-stretchable measuring tape at the level of the umbilicus with the participant in a standing position, feet slightly apart, and arms relaxed at the sides. Measurements were taken at the end of a normal expiration to minimize variability. Each measurement was repeated twice, and the mean value was recorded. Abdominal circumference was used as an objective indicator of abdominal distension associated with functional constipation.

Study contacts

Contact information is provided by the study sponsor or research team.

Abanob W. M. Fourtaneeh, Master

CONTACT

[email protected]

+201220017321

Mariam O. Grace, Assistant Professor

CONTACT

[email protected]

+201281940603

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 22, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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