Implementation of Physical Therapy Protocol for Functional Constipation

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат 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.
• Процедура 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.
• Устройство 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. T
• Процедура 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 ascen
• Процедура 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 perfo
• Поведенческое 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
• Устройство 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.

Первичные конечные точки

• Constipation Severity [Срок оценки: 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).]

Вторичные конечные точки (2)

• Constipation-Related Quality of Life [Срок оценки: 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 [Срок оценки: Baseline (pre-test) and after completion of the 6-week intervention (post-test).]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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. PMID 34603471
• 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
• 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
• Camilleri M. Gastrointestinal motility disorders in neurologic disease. J Clin Invest. 2021 Feb 15;131(4):e143771. doi: 10.1172/JCI143771. PMID 33586685
• 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
• 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
• 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.

Идентификаторы

NCT: NCT07719504 · P.T.REC/012/006547

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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