Efficacy of Combined Interferential Therapy and Electronic Cupping Therapy for Chronic Constipation Management

Not Applicable

Active, not recruiting

• Conditions: Constipation
• Interventions: Other: interferential therapy, electronic cupping therapy in addition to aerobic exercises; Other: interferential therapy in addition to aerobic exercise; Other: Aerobic exercise; Other: electronic cupping therapy in addition to aerobic exercise

• Registration Number: NCT06611852
• Lead Sponsor: Middle East University

Brief Summary

Constipation is a common gastrointestinal issue affecting individuals worldwide. Interferential therapy, a form of electrotherapy, has been suggested to have potential benefits in improving gastrointestinal motility and relieving constipation symptoms. Introducing of a new method like electronic cupping therapy with interferential therapy may optimize the therapeutic outcomes by potentially increasing bowel movements and improving overall gastrointestinal function.

Detailed Description

Objective: The purpose of this study was to assess the effectiveness of a combined treatment regimen that includes interferential therapy and electronic cupping therapy on the symptoms of chronic constipation, as well as gastrointestinal health outcomes.

Methods: This study involved 110 patients with chronic constipation, consisting of 60 females and 50 males, ranging in age from 20 to 40 years. Each participant underwent evaluations using Abdominal Ultrasonography and a standardized constipation scoring system. All participants were allocated into three groups; Group (A) received interferential therapy with aerobic exercises, Group (B) received electronic cupping therapy and aerobic exercise in the form of treadmill exercise and stationary bicycle 3 sessions/week for four weeks, and Group (c) received interferential therapy, electronic cupping therapy in addition to aerobic exercises.

Study Timeline

• Study Start: 2023-02-14
• Status Verified: 2024-09
• Study First Submitted: 2024-09-18
• Study First Submitted QC: 2024-09-22
• Last Update Submitted: 2024-09-22
• Study First Posted: 2024-09-25
• Last Update Posted: 2024-09-25
• Primary Completion: 2024-10-20
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• history of Chronic Constipation (CC), as defined by either experiencing two or fewer Complete Spontaneous Bowel Movements (CSBMs) per week for a minimum of 6 consecutive months before the screening visit
• Reporting a sensation of incomplete evacuation or straining during at least a quarter of their bowel movements (according to the generally accepted definition of constipation).
• Patients must have had CC persisting for more than 6 months, failed to respond to or be intolerant of medical treatment for at least 3 months

Exclusion Criteria

• pregnant or lactating women
• Chronic Constipation (CC) resulting from anorectal malformations such as colorectal or anal organic lesions, pelvic floor disorders requiring surgical intervention as determined by the investigator (such as rectal prolapse, rectocele, or enterocele)
• presence of implanted electronic devices like cardiac pacemakers, defibrillators, cardiac pumps, or spinal stimulators
• CC attributable to medications or neurologic, endocrine, or metabolic conditions
• prior history of partial colectomy; conditions like megacolon, megarectum, or colonic inertia
• skin abnormalities that hinder the placement of electrodes
• women lacking adequate contraception (hormonal or intrauterine device).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group (D)	interferential therapy, electronic cupping therapy in addition to aerobic exercises	-
Group (C)	interferential therapy in addition to aerobic exercise	received interferential therapy
Group (A)	Aerobic exercise	received aerobic exercises
Group (B)	electronic cupping therapy in addition to aerobic exercise	received electronic cupping therapy

Primary Outcome Measures

Name	Time	Method
Ultrasonography	6 weeks	Ultrasonography (M-Turbo, Sonosite, Bothell, WA, USA) was used to assess the large intestine during CC by using imaging technology that gave the healthcare professionals the ability to visualize the structure and function of the patients\' bowel with a curved-array (2-5 MHz) probe.
Constipation scoring system.	6 weeks	A constipation scoring system was used to evaluate the severity of CC. It measures the frequency of the bowel movements, stool consistency, straining during defecation, and sensation of incomplete evacuation. It produces a numerical score ranging from 0 to 30, with 0 indicating no constipation and 30 indicating severe constipation

Trial Locations

Locations (1)

October 6 university; 🇪🇬 October city, Giza, Egypt