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Implementation of Physical Therapy Protocol for Functional Constipation

21 luglio 2026 aggiornato da: Abanob William Makram Fourtaneeh, Cairo University

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

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Control group (A)
Participants in this arm will receive medication prescribed by an internal medicine physician as the standard medical treatment for functional constipation. No physiotherapy intervention will be administered during the 6-week study period.
Droga: Standard medical treatment
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.
Sperimentale: Study group (B)
Participants in this arm will receive medication prescribed by an internal medicine physician in addition to Maitland Orthopedic Manual Therapy (MOMT), Electrical Russian Stimulation (ERS), passive peristalsis motion techniques, Isometric Abdominal Muscle Exercises (IAME), and hot packs as a home program. The physiotherapy interventions will be administered three sessions per week for six weeks.
Droga: Standard medical treatment
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.
Procedura: Maitland orthopedic manual therapy (MOMT)
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.
Dispositivo: Russian current stimulation (ERS)
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.
Procedura: Passive peristalsis motion techniques
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.
Comportamentale: Isometric abdominal muscle exercises (IAME)
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.
Dispositivo: Hot pack application
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.
Sperimentale: Study group (C)
Participants in this arm will receive medication prescribed by an internal medicine physician in addition to Maitland Orthopedic Manual Therapy (MOMT), passive peristalsis motion techniques, Isometric Abdominal Muscle Exercises (IAME), and hot packs as a home program, administered three sessions per week for six weeks. Osteopathic Visceral Manipulation (OVM) will be administered once weekly for six weeks.
Droga: Standard medical treatment
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.
Procedura: Maitland orthopedic manual therapy (MOMT)
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.
Procedura: Passive peristalsis motion techniques
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.
Comportamentale: Isometric abdominal muscle exercises (IAME)
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.
Dispositivo: Hot pack application
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.
Procedura: Osteopathic visceral manipulation (OVM)
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.
Sperimentale: Study group (D)
Participants in this arm will receive medication prescribed by an internal medicine physician in addition to Maitland Orthopedic Manual Therapy (MOMT), Electrical Russian Stimulation (ERS), passive peristalsis motion techniques, Isometric Abdominal Muscle Exercises (IAME), and hot packs as a home program, administered three sessions per week for six weeks. Osteopathic Visceral Manipulation (OVM) will be administered once weekly for six weeks.
Droga: Standard medical treatment
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.
Procedura: Maitland orthopedic manual therapy (MOMT)
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.
Dispositivo: Russian current stimulation (ERS)
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.
Procedura: Passive peristalsis motion techniques
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.
Comportamentale: Isometric abdominal muscle exercises (IAME)
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.
Dispositivo: Hot pack application
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.
Procedura: Osteopathic visceral manipulation (OVM)
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Constipation Severity
Lasso di tempo: 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.
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).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Constipation-Related Quality of Life
Lasso di tempo: 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.
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.
Abdominal Circumference
Lasso di tempo: 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.
Baseline (pre-test) and after completion of the 6-week intervention (post-test).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Cairo University

Pubblicazioni e link utili

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Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

1 ottobre 2026

Completamento dello studio (Stimato)

1 febbraio 2027

Date di iscrizione allo studio

Primo inviato

18 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

18 luglio 2026

Primo Inserito (Effettivo)

22 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

23 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • P.T.REC/012/006547

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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