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

NCT06611852 | Active Not Recruiting DMC

• 2 other identifiers: 2513middle east university
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation

Keywords

Chronic Constipation; Interferential Therapy; Electronic Cupping Therapy

Outcome Measures

Primary Outcomes (2)

• Ultrasonography

  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.

  6 weeks

• Constipation scoring system.

  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

  6 weeks

Study Arms (4)

Group (A)

EXPERIMENTAL

received aerobic exercises

Other: Aerobic exercise

Group (B)

EXPERIMENTAL

received electronic cupping therapy

Other: electronic cupping therapy in addition to aerobic exercise

Group (C)

EXPERIMENTAL

received interferential therapy

Other: interferential therapy in addition to aerobic exercise

Group (D)

EXPERIMENTAL

Other: interferential therapy, electronic cupping therapy in addition to aerobic exercises

Interventions

Aerobic exercise 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.

Also known as: Group (A)

Group (A)

electronic cupping therapy in addition to aerobic exercise OTHER

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

Group (B)

interferential therapy in addition to aerobic exercise 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 (C)

interferential therapy, electronic cupping therapy in addition to aerobic exercises OTHER

interferential therapy, electronic cupping therapy in addition to aerobic exercises

Group (D)

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Middle East University: lead

Study Sites (1)

October 6 university

October City, Giza Governorate, 6892, Egypt

Location

MeSH Terms

Conditions

Constipation

Interventions

Exercise; Population Groups

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Demography; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 25, 2024
• Study Start: February 14, 2023
• Primary Completion: October 20, 2024
• Study Completion: November 30, 2024
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)