Implementation of Physical Therapy Protocol for Functional Constipation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Constipation Severity
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Standard medical treatment (Drug)
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.
干预措施: Standard medical treatment (Drug)
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.
干预措施: Maitland orthopedic manual therapy (MOMT) (Procedure)
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.
干预措施: Russian current stimulation (ERS) (Device)
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.
干预措施: Passive peristalsis motion techniques (Procedure)
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.
干预措施: Isometric abdominal muscle exercises (IAME) (Behavioral)
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.
干预措施: Hot pack application (Device)
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.
干预措施: Standard medical treatment (Drug)
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.
干预措施: Maitland orthopedic manual therapy (MOMT) (Procedure)
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.
干预措施: Passive peristalsis motion techniques (Procedure)
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.
干预措施: Osteopathic visceral manipulation (OVM) (Procedure)
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.
干预措施: Isometric abdominal muscle exercises (IAME) (Behavioral)
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.
干预措施: Hot pack application (Device)
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.
干预措施: Hot pack application (Device)
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.
干预措施: Standard medical treatment (Drug)
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.
干预措施: Maitland orthopedic manual therapy (MOMT) (Procedure)
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.
干预措施: Russian current stimulation (ERS) (Device)
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.
干预措施: Passive peristalsis motion techniques (Procedure)
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.
干预措施: Osteopathic visceral manipulation (OVM) (Procedure)
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.
干预措施: Isometric abdominal muscle exercises (IAME) (Behavioral)
结局指标
主要结局
Constipation Severity
时间窗: 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.
次要结局
- 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).)
研究者
Abanob William Makram Fourtaneeh
Principal Investigator
Cairo University