Implementation of Physical Therapy Protocol for Functional Constipation

NCT07719504 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/006547
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

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; Isometric Abdominal Muscle Exercises; Abdominal Massage; Abdominal Circumference

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

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

Study Arms (4)

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.

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.

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.

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.

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

Interventions

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.

Study group (B); Study group (D)

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.

Study group (B); Study group (C); Study group (D)

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.

Study group (C); Study group (D)

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.

Study group (B); Study group (C); Study group (D)

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.

Study group (B); Study group (C); Study group (D)

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.

Study group (B); Study group (C); Study group (D)

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.

Control group (A); Study group (B); Study group (C); Study group (D)

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (19)

• 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

  RESULT

• 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.

  PMID: 34603471 RESULT

• Ghosh, 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

  RESULT

• 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.

  PMID: 38848393 RESULT

• Camilleri M. Gastrointestinal motility disorders in neurologic disease. J Clin Invest. 2021 Feb 15;131(4):e143771. doi: 10.1172/JCI143771.

  PMID: 33586685 RESULT

• Camilleri 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.

  PMID: 32718574 RESULT

• Salari 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.

  PMID: 39707279 RESULT

• Rahmy, 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.

  RESULT

• 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

  RESULT

• 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.

  PMID: 31945360 RESULT

• Barberio 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.

  PMID: 34090581 RESULT

• Song 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.

  PMID: 33737952 RESULT

• Dogan 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.

  PMID: 35554601 RESULT

• Morisawa 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.

  PMID: 25642064 RESULT

• Villalta 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.

  PMID: 31372099 RESULT

• Khan, N., Bulbuli, A., & Effect, B. A. (2024a). Effect of Russian Current and Structured Exercise Program on Postpartum Diastasis Recti Abdominis: A Case Series. Internet Journal of Allied Health Sciences and Practice, 22(2), 3. https://doi.org/10.46743/1540-580X/2024.2400

  RESULT

• Abdel Mobdy Radwan DNS, S., Abd-EL-Sattar Ahmed DNS, M., Hamed Farahat DNS, N., & Saied Ahmed Zaied, A. (2021). Health Education Program for Improving Quality of Life of Older Adults Suffering from Chronic Constipation. Egyptian Journal of Health Care, 12(1), 1732-1748. https://doi.org/10.21608/EJHC.2021.256663

  RESULT

• Dias FC, Boilesen SN, Tahan S, Melli L, Morais MB. Overweight status, abdominal circumference, physical activity, and functional constipation in children. Rev Assoc Med Bras (1992). 2023 Feb 20;69(3):386-391. doi: 10.1590/1806-9282.20220845. eCollection 2023.

  PMID: 36820766 RESULT

• Koo JP, Choi JH, Kim NJ. The effects of maitland orthopedic manual therapy on improving constipation. J Phys Ther Sci. 2016 Oct;28(10):2857-2861. doi: 10.1589/jpts.28.2857. Epub 2016 Oct 28.

  PMID: 27821950 RESULT

Central Study Contacts

Abanob W. M. Fourtaneeh, Master

CONTACT

+201220017321; abanobwilliamch@gmail.com

Mariam O. Grace, Assistant Professor

CONTACT

+201281940603; Dr.mariamomran@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 18, 2026
• First Posted: July 22, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share