NCT07344571

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Apr 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Apr 2023Sep 2026

Study Start

First participant enrolled

April 15, 2023

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

January 1, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2026

Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

3.4 years

First QC Date

January 1, 2026

Last Update Submit

January 14, 2026

Conditions

Keywords

constipationsacroiliac joint disorders

Outcome Measures

Primary Outcomes (3)

  • Distraction Test (SI Joint Gapping)

    Position of patient: Supine. force: posterior-lateral force to both ASISs at same time results: pain in SI region

    6 months

  • Thigh Thrust Test

    Position of patient: Supine, hip and knee of affected side flexed 90°. force: Stabilize opposite ASIS, apply posterior force through femur. result: Focal SI pain.

    6 months

  • Sacral Thrust Test

    Position of patient: Prone. force: Apply an anterior shear force to sacrum (over S2). result: Reproduction of pain in SI region.

    6 months

Study Arms (2)

group A: Patients with constipation

Both the rectum and the sacroiliac joint share innervation from sacral spinal segments S2-S4. Neural signals from the rectum can influence SI joint sensory nerves via viscerosomatic and somatovisceral reflex arcs. This means chronic constipation may both result from and contribute to SI joint dysfunction.

group B: Patients without constipation

Accumulated stool in the rectum and sigmoid colon can physically press on pelvic structures, stretching ligaments and tensioning muscles around the SI joint. This may trigger or mimic SI joint dysfunction.

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

male and female participant

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
  • Not having functional constipation

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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bassam Ahmed Nabil

October City, Giza Governorate, 6892, Egypt

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

January 1, 2026

First Posted

January 15, 2026

Study Start

April 15, 2023

Primary Completion (Estimated)

September 10, 2026

Study Completion (Estimated)

September 10, 2026

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations