Implementation of Physical Therapy Protocol for Functional Constipation
2026年7月21日 更新者：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
研究概览
地位
尚未招聘
条件
详细说明
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.
研究类型
介入性
注册 (估计的)
60
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Abanob W. M. Fourtaneeh, Master
- 电话号码：+201220017321
- 邮箱：abanobwilliamch@gmail.com
研究联系人备份
- 姓名：Mariam O. Grace, Assistant Professor
- 电话号码：+201281940603
- 邮箱：Dr.mariamomran@cu.edu.eg
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
不
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：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.
|
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.
|
|
实验性的：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.
|
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 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 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 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.
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.
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.
|
|
实验性的：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.
|
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 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.
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.
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.
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.
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.
|
|
实验性的：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.
|
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 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 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 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.
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.
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.
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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Constipation Severity
大体时间：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).
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Constipation-Related Quality of Life
大体时间：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
大体时间：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).
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
- 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.
- 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.
- Camilleri M. Gastrointestinal motility disorders in neurologic disease. J Clin Invest. 2021 Feb 15;131(4):e143771. doi: 10.1172/JCI143771.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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
- 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.
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月1日
初级完成 (估计的)
2026年10月1日
研究完成 (估计的)
2027年2月1日
研究注册日期
首次提交
2026年7月18日
首先提交符合 QC 标准的
2026年7月18日
首次发布 (实际的)
2026年7月22日
研究记录更新
最后更新发布 (实际的)
2026年7月23日
上次提交的符合 QC 标准的更新
2026年7月21日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- P.T.REC/012/006547
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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