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

NCT ID: NCT06611852

Last Updated: 2024-09-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-14
• Study Completion Date: 2024-11-30

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.

Conditions

Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group (A)

received aerobic exercises

Group Type: EXPERIMENTAL

Aerobic exercise

Intervention Type: OTHER

Warm-up (5 minutes): Started with a 5-minute warm-up on the stationary bike at a low intensity to prepare the muscles for the workout.

Interval Training (15 minutes): Alternated between 1 minute of high-intensity cycling (pedaling at a faster pace with higher resistance) and 2 minutes of moderate-intensity cycling (steady pace with moderate resistance). This interval was repeated for a total of 15 minutes.

Hill Climbing (10 minutes): The resistance was increased on the stationary bike to simulate climbing a hill. Pedal at a slower pace but with higher resistance for 10 minutes to engage the muscles of legs and core.

Cool Down (5 minutes): The stationary cycling session was finished with a 5-minute cool down at a low intensity to gradually lower the heart rate and avoid fatigue.

Group (B)

received electronic cupping therapy

Group Type: EXPERIMENTAL

electronic cupping therapy in addition to aerobic exercise

Intervention Type: OTHER

Four devices of electronic cupping therapy were equipped with 3.5-inch diameter cups (Becommend, model number: BE007, ASIN: B09PVF72RJ, China).

Group (C)

received interferential therapy

Group Type: EXPERIMENTAL

interferential therapy in addition to aerobic exercise

Intervention Type: OTHER

interferential current (Endomed 482, SN/29.382, Netherlands) was delivered by the following parameters: a carrier frequency of 5-kHz, a beat frequency of 80-160 Hz, and an intensity level below 33 mA. Four carbon rubber electrodes (8x12 cm) were used and fixed by a large abdominal strap with a wet spongy

Group (D)

Group Type: EXPERIMENTAL

interferential therapy, electronic cupping therapy in addition to aerobic exercises

Intervention Type: OTHER

interferential therapy, electronic cupping therapy in addition to aerobic exercises

Interventions

Aerobic exercise

Warm-up (5 minutes): Started with a 5-minute warm-up on the stationary bike at a low intensity to prepare the muscles for the workout.

Interval Training (15 minutes): Alternated between 1 minute of high-intensity cycling (pedaling at a faster pace with higher resistance) and 2 minutes of moderate-intensity cycling (steady pace with moderate resistance). This interval was repeated for a total of 15 minutes.

Hill Climbing (10 minutes): The resistance was increased on the stationary bike to simulate climbing a hill. Pedal at a slower pace but with higher resistance for 10 minutes to engage the muscles of legs and core.

Cool Down (5 minutes): The stationary cycling session was finished with a 5-minute cool down at a low intensity to gradually lower the heart rate and avoid fatigue.

Intervention Type: OTHER

electronic cupping therapy in addition to aerobic exercise

Four devices of electronic cupping therapy were equipped with 3.5-inch diameter cups (Becommend, model number: BE007, ASIN: B09PVF72RJ, China).

Intervention Type: OTHER

interferential therapy in addition to aerobic exercise

interferential current (Endomed 482, SN/29.382, Netherlands) was delivered by the following parameters: a carrier frequency of 5-kHz, a beat frequency of 80-160 Hz, and an intensity level below 33 mA. Four carbon rubber electrodes (8x12 cm) were used and fixed by a large abdominal strap with a wet spongy

Intervention Type: OTHER

interferential therapy, electronic cupping therapy in addition to aerobic exercises

interferential therapy, electronic cupping therapy in addition to aerobic exercises

Intervention Type: OTHER

Other Intervention Names

Group (A)

Eligibility Criteria

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).

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Middle East University

OTHER

Sponsor Role: lead

Responsible Party

Emad Eldin Mohamed

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

October 6 university

October City, Giza Governorate, Egypt

Countries

Egypt

Other Identifiers

middle east university

Identifier Type: OTHER

Identifier Source: secondary_id

2513

Identifier Type: -

Identifier Source: org_study_id