Effect of Shock Waves Therapy on Chronic Anal Fissure

NCT ID: NCT04793347

Last Updated: 2021-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-10

Study Completion Date

2021-05-30

Brief Summary

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the study conducted to assess if there is an effect of Extracorporeal Shock Wave Treatment on anal fissure

Detailed Description

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Design of the study:

A prospective, randomized, blind, paired (right/left) comparison.

Materials:

Measurement tool:

* healing of anal fissure,
* Wexner Constipation Scoring System
* anal pain intensity by means of a 10-point visual analogue scale (VAS)

Therapeutic instruments:

•. shock waves

• topical application of 0.4% glyceryl trinitrate (GTN) ointment

Methods:

• Testing procedures: The assessment will be performed before commencing treatment, after 4 and 8 weeks of the treatment.

• Treatment procedures: Patients will be assigned randomly into two groups equal in number: shock waves Group: twenty patients will receive the shockwaves on perianal area of for 4 weeks (3 sessions /week). control Group: twenty patients will receive the recommended routine medical treatment include topical application of 0.4% glyceryl trinitrate (GTN) ointment only..

Conditions

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Chronic Anal Fissure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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shock waves

group of patients with anal fissure will be treated with shock waves

Group Type EXPERIMENTAL

shock master (shock waves device)

Intervention Type DEVICE

device produces shock waves

Interventions

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shock master (shock waves device)

device produces shock waves

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patient with chronic anal fissure
* symptomatic for at least 6 months
* failed conservative measures

Exclusion Criteria

* Pregnant women,
* cardiac patients,
* patients with a pacemaker,
* low molecular heparin or warfarin treatment,
* neurological disease,
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role collaborator

amr bayoumi salama

OTHER

Sponsor Role lead

Responsible Party

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amr bayoumi salama

faculty of physical therapy. Cairo university

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Amr

Giza, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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nu5332

Identifier Type: -

Identifier Source: org_study_id

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