Effect of Shock Waves Therapy on Chronic Anal Fissure

amr bayoumi salama

Status: Unknown

Conditions: Chronic Anal Fissure

Treatments: Device: shock master (shock waves device)

Study type: Interventional

Funder types: Other

Identifiers

NCT04793347

nu5332

Details and patient eligibility

About

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

Full description

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..

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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,

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

shock waves

Experimental group

Description:

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

Treatment:

Device: shock master (shock waves device)