Functional Constipation (FC)NCT07719504
Implementation of Physical Therapy Protocol for Functional Constipation
A study testing Standard medical treatment, Maitland orthopedic manual therapy (MOMT) and Russian current stimulation (ERS) in people with Functional Constipation (FC), run by Cairo University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Functional Constipation (FC)
- What is being tested?
- Standard medical treatment, Maitland orthopedic manual therapy (MOMT) and Russian current stimulation (ERS)
- Type of treatment
- Medical device, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
Read the detailed description
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.
- Conditions
- Functional Constipation (FC)
- Being tested
- Standard medical treatment, Maitland orthopedic manual therapy (MOMT), Russian current stimulation (ERS), Passive peristalsis motion techniques, Osteopathic visceral manipulation (OVM)
- Keywords
- Habitual Constipation, Constipation Severity, Functional Constipation, Constipation-Related Quality of Life, Maitland Orthopedic Manual Therapy, Electrical Russian Stimulation, Osteopathic Visceral Manipulation, Passive Peristalsis Motion Techniques, Isometric Abdominal Muscle Exercises, Abdominal Massage, Abdominal Circumference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard medical treatmentDrug
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 or surgery
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 techniquesProcedure or surgery
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 or surgery
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)Behavioural
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 applicationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group (A) | Active comparator | 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. Receives: Drug: Standard medical treatment |
| Study group (B) | Experimental | 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. Receives: Drug: Standard medical treatment; Procedure: Maitland orthopedic manual therapy (MOMT); Device: Russian current stimulation (ERS); Procedure: Passive peristalsis motion techniques; Behavioral: Isometric abdominal muscle exercises (IAME); Device: Hot pack application |
| Study group (C) | Experimental | 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. Receives: Drug: Standard medical treatment; Procedure: Maitland orthopedic manual therapy (MOMT); Procedure: Passive peristalsis motion techniques; Procedure: Osteopathic visceral manipulation (OVM); Behavioral: Isometric abdominal muscle exercises (IAME); Device: Hot pack application |
| Study group (D) | Experimental | 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. Receives: Drug: Standard medical treatment; Procedure: Maitland orthopedic manual therapy (MOMT); Device: Russian current stimulation (ERS); Procedure: Passive peristalsis motion techniques; Procedure: Osteopathic visceral manipulation (OVM); Behavioral: Isometric abdominal muscle exercises (IAME); Device: Hot pack application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constipation Severity
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.
Measured: 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).
Secondary outcomes (2)
Constipation-Related Quality of Life
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.
Measured: 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
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.
Measured: Baseline (pre-test) and after completion of the 6-week intervention (post-test).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Functional Constipation (FC)Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a four groups , parallel-group, randomized controlled trial with a pre-test/post-test design. Sixty participants will be randomly allocated into four equal groups (15 participants per group) and will remain in their assigned group throughout the 6-week intervention period. Group A (control) will receive medication prescribed by an internal medicine physician only. Group B will receive medication plus 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. Group C will receive medication plus MOMT, Osteopathic Visceral Manipulation (OVM), passive peristalsis motion techniques, IAME and hot packs as a home program. Group D will receive medication plus MOMT, ERS, OVM, passive peristalsis motion techniques, IAME and hot packs as a home program. Physiotherapy interventions will be provided three times weekly for six weeks.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abanob William Makram Fourtaneeh, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719504
- Sponsor's protocol ID
- P.T.REC/012/006547
- Status last verified
- Jul 2026
- First submitted
- 18 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gallo, A., Pellegrino, S., Pero, E., Agnitelli, M. C., Parlangeli, C., Landi, F., & Montalto, M. (2024). Main Disorders of Gastrointestinal Tract in Older People: An Overview. Gastrointestinal Disorders 2024, Vol. 6, Pages 313-336, 6(1), 313-336. https://doi.org/10.3390/GIDISORD6010022
Wang JK, Yao SK. Roles of Gut Microbiota and Metabolites in Pathogenesis of Functional Constipation. Evid Based Complement Alternat Med. 2021 Sep 21;2021:5560310. doi: 10.1155/2021/5560310. eCollection 2021.
PubMed 34603471Ghosh, J., Sanyal, P., Singh, K., Choudhury, S. R., & Koner, S. (2023). Prevalence of Constipation and its Relationship with Dietary Habits Among College Going Girls in the Age Group of 18-25 Years of Kolkata, West Bengal, India. Acta Scientific Gastrointestinal Disorders, 6(3), 03-13. https://doi.org/10.31080/ASGIS.2023.06.0516
Syam AF, Utari AP, Hasanah NH, Rizky A, Abdullah M. Prevalence and factors associated with celiac disease in high-risk patients with functional gastrointestinal disorders. PLoS One. 2024 Jun 7;19(6):e0297605. doi: 10.1371/journal.pone.0297605. eCollection 2024.
PubMed 38848393Camilleri M. Gastrointestinal motility disorders in neurologic disease. J Clin Invest. 2021 Feb 15;131(4):e143771. doi: 10.1172/JCI143771.
PubMed 33586685Camilleri M, Brandler J. Refractory Constipation: How to Evaluate and Treat. Gastroenterol Clin North Am. 2020 Sep;49(3):623-642. doi: 10.1016/j.gtc.2020.05.002. Epub 2020 Jun 14.
PubMed 32718574Salari N, Mohamadi S, Hemmati M, Fallahi A, Rasoulpoor S, Zarei H, Shohaimi S, Mohammadi M. Global prevalence of constipation during pregnancy: a systematic review and meta-analysis. BMC Pregnancy Childbirth. 2024 Dec 20;24(1):836. doi: 10.1186/s12884-024-07057-y.
PubMed 39707279Rahmy, A. F., Ibrahim, E. M., & Youssef, S. M. (2021). Effect of Interferential Therapy versus Aerobic Exercise on Chronic Constipation. International Journal of Recent Advances in Multidisciplinary Research. Published June 26, 2021. Paper No. 3620.
Eshaghi, A., Norouzadeh, R., & Jadid-Milini, M. (2024). The effect of abdominal heat therapy on constipation. Gastrointestinal Nursing, 22(3), 160-165. https://doi.org/10.12968/gasn.2024.22.3.160
Bharucha AE, Lacy BE. Mechanisms, Evaluation, and Management of Chronic Constipation. Gastroenterology. 2020 Apr;158(5):1232-1249.e3. doi: 10.1053/j.gastro.2019.12.034. Epub 2020 Jan 13.
PubMed 31945360Barberio B, Judge C, Savarino EV, Ford AC. Global prevalence of functional constipation according to the Rome criteria: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2021 Aug;6(8):638-648. doi: 10.1016/S2468-1253(21)00111-4. Epub 2021 Jun 4.
PubMed 34090581Song BK, Han D, Brellenthin AG, Kim YS. Effects of core strengthening exercise on colon transit time in young adult women. J Exerc Sci Fit. 2021 Jul;19(3):158-165. doi: 10.1016/j.jesf.2021.02.001. Epub 2021 Feb 20.
PubMed 33737952Dogan IG, Gursen C, Akbayrak T, Balaban YH, Vahabov C, Uzelpasaci E, Ozgul S. Abdominal Massage in Functional Chronic Constipation: A Randomized Placebo-Controlled Trial. Phys Ther. 2022 Jul 4;102(7):pzac058. doi: 10.1093/ptj/pzac058.
PubMed 35554601Morisawa T, Takahashi T, Nishi S. The effect of a physiotherapy intervention on intestinal motility. J Phys Ther Sci. 2015 Jan;27(1):165-8. doi: 10.1589/jpts.27.165. Epub 2015 Jan 9.
PubMed 25642064Villalta Santos L, Lisboa Cordoba L, Benite Palma Lopes J, Santos Oliveira C, Andre Collange Grecco L, Bovi Nunes Andrade AC, Pasin Neto H. Active Visceral Manipulation Associated With Conventional Physiotherapy in People With Chronic Low Back Pain and Visceral Dysfunction: A Preliminary, Randomized, Controlled, Double-Blind Clinical Trial. J Chiropr Med. 2019 Jun;18(2):79-89. doi: 10.1016/j.jcm.2018.11.005. Epub 2019 Jun 27.
PubMed 31372099
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Physical Therapy Protocol for Functional Constipation
- ClinicalTrials.gov ID
- NCT07719504
- Acronym / sponsor ID
- P.T.REC/012/006547
- Conditions
- Functional Constipation (FC)
- Keywords
- Habitual Constipation, Constipation Severity, Functional Constipation, Constipation-Related Quality of Life, Maitland Orthopedic Manual Therapy, Electrical Russian Stimulation, Osteopathic Visceral Manipulation, Passive Peristalsis Motion Techniques
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- This study is a four groups , parallel-group, randomized controlled trial with a pre-test/post-test design. Sixty participants will be randomly allocated into four equal groups (15 participants per group) and will remain in their assigned group throughout the 6-week intervention period. Group A (control) will receive medication prescribed by an internal medicine physician only. Group B will receive medication plus 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. Group C will receive medication plus MOMT, Osteopathic Visceral Manipulation (OVM), passive peristalsis motion techniques, IAME and hot packs as a home program. Group D will receive medication plus MOMT, ERS, OVM, passive peristalsis motion techniques, IAME and hot packs as a home program. Physiotherapy interventions will be provided three times weekly for six weeks.
| Arm | Type | Receives |
|---|---|---|
| Control group (A) | Active comparator | Drug: Standard medical treatmentParticipants 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. |
| Study group (B) | Experimental | Drug: Standard medical treatment, Procedure: Maitland orthopedic manual therapy (MOMT), Device: Russian current stimulation (ERS), Procedure: Passive peristalsis motion techniques, Behavioral: Isometric abdominal muscle exercises (IAME), Device: Hot pack applicationParticipants 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. |
| Study group (C) | Experimental | Drug: Standard medical treatment, Procedure: Maitland orthopedic manual therapy (MOMT), Procedure: Passive peristalsis motion techniques, Procedure: Osteopathic visceral manipulation (OVM), Behavioral: Isometric abdominal muscle exercises (IAME), Device: Hot pack applicationParticipants 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. |
| Study group (D) | Experimental | Drug: Standard medical treatment, Procedure: Maitland orthopedic manual therapy (MOMT), Device: Russian current stimulation (ERS), Procedure: Passive peristalsis motion techniques, Procedure: Osteopathic visceral manipulation (OVM), Behavioral: Isometric abdominal muscle exercises (IAME), Device: Hot pack applicationParticipants 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- Pregnancy.
- Recent abdominal surgery.
- Patients with acute ischemic bowel disease.
- Intestinal obstruction.
- Patients with Celiac Disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard medical treatmentParticipants 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. | Drug | Control group (A), Study group (B), Study group (C), Study group (D) |
| 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. | Procedure or surgery | Study group (B), Study group (C), Study group (D) |
| 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. | Device | Study group (B), Study group (D) |
| Passive peristalsis motion techniquesPassive 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. | Procedure or surgery | Study group (B), Study group (C), Study group (D) |
| 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. | Procedure or surgery | Study group (C), Study group (D) |
| 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. | Behavioural | Study group (B), Study group (C), Study group (D) |
| Hot pack applicationParticipants 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. | Device | Study group (B), Study group (C), Study group (D) |
Primary outcome
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.
2 secondary outcomes
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.
Abdominal Circumference
Time frame: Baseline (pre-test) and after completion of the 6-week intervention (post-test).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Results publicationGallo, A., Pellegrino, S., Pero, E., Agnitelli, M. C., Parlangeli, C., Landi, F., & Montalto, M. (2024). Main Disorders of Gastrointestinal Tract in Older People: An Overview. Gastrointestinal Disorders 2024, Vol. 6, Pages 313-336, 6(1), 313-336. https://doi.org/10.3390/GIDISORD6010022
- Results publication: PubMed 34603471Wang JK, Yao SK. Roles of Gut Microbiota and Metabolites in Pathogenesis of Functional Constipation. Evid Based Complement Alternat Med. 2021 Sep 21;2021:5560310. doi: 10.1155/2021/5560310. eCollection 2021.
- Results publicationGhosh, J., Sanyal, P., Singh, K., Choudhury, S. R., & Koner, S. (2023). Prevalence of Constipation and its Relationship with Dietary Habits Among College Going Girls in the Age Group of 18-25 Years of Kolkata, West Bengal, India. Acta Scientific Gastrointestinal Disorders, 6(3), 03-13. https://doi.org/10.31080/ASGIS.2023.06.0516
- Results publication: PubMed 38848393Syam AF, Utari AP, Hasanah NH, Rizky A, Abdullah M. Prevalence and factors associated with celiac disease in high-risk patients with functional gastrointestinal disorders. PLoS One. 2024 Jun 7;19(6):e0297605. doi: 10.1371/journal.pone.0297605. eCollection 2024.
- Results publication: PubMed 33586685Camilleri M. Gastrointestinal motility disorders in neurologic disease. J Clin Invest. 2021 Feb 15;131(4):e143771. doi: 10.1172/JCI143771.
- Results publication: PubMed 32718574Camilleri M, Brandler J. Refractory Constipation: How to Evaluate and Treat. Gastroenterol Clin North Am. 2020 Sep;49(3):623-642. doi: 10.1016/j.gtc.2020.05.002. Epub 2020 Jun 14.
- Results publication: PubMed 39707279Salari N, Mohamadi S, Hemmati M, Fallahi A, Rasoulpoor S, Zarei H, Shohaimi S, Mohammadi M. Global prevalence of constipation during pregnancy: a systematic review and meta-analysis. BMC Pregnancy Childbirth. 2024 Dec 20;24(1):836. doi: 10.1186/s12884-024-07057-y.
- Results publicationRahmy, A. F., Ibrahim, E. M., & Youssef, S. M. (2021). Effect of Interferential Therapy versus Aerobic Exercise on Chronic Constipation. International Journal of Recent Advances in Multidisciplinary Research. Published June 26, 2021. Paper No. 3620.
- Results publicationEshaghi, A., Norouzadeh, R., & Jadid-Milini, M. (2024). The effect of abdominal heat therapy on constipation. Gastrointestinal Nursing, 22(3), 160-165. https://doi.org/10.12968/gasn.2024.22.3.160
- Results publication: PubMed 31945360Bharucha AE, Lacy BE. Mechanisms, Evaluation, and Management of Chronic Constipation. Gastroenterology. 2020 Apr;158(5):1232-1249.e3. doi: 10.1053/j.gastro.2019.12.034. Epub 2020 Jan 13.
- Results publication: PubMed 34090581Barberio B, Judge C, Savarino EV, Ford AC. Global prevalence of functional constipation according to the Rome criteria: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2021 Aug;6(8):638-648. doi: 10.1016/S2468-1253(21)00111-4. Epub 2021 Jun 4.
- Results publication: PubMed 33737952Song BK, Han D, Brellenthin AG, Kim YS. Effects of core strengthening exercise on colon transit time in young adult women. J Exerc Sci Fit. 2021 Jul;19(3):158-165. doi: 10.1016/j.jesf.2021.02.001. Epub 2021 Feb 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Standard medical treatment, Maitland orthopedic manual therapy (MOMT) and Russian current stimulation (ERS) in people with Functional Constipation (FC), run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abanob W. M. Fourtaneeh, Master (+201220017321, abanobwilliamch@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07719504, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.