Effect of Shock Waves Therapy on Chronic Anal Fissure

Chronic Anal Fissure Clinical Trial

Official title:

Effect of Shock Waves Therapy on Anal Fissure

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04793347
• Other study ID #: nu5332
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 10, 2021
• Est. completion date: May 30, 2021

Study information

• Verified date: March 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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..

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: May 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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,

Related Conditions & MeSH terms

• Chronic Anal Fissure
• Fissure in Ano

Intervention

Device:
• shock master (shock waves device)
device produces shock waves

Locations

Country	Name	City	State
Egypt	Amr	Giza

Sponsors (2)

Lead Sponsor	Collaborator
amr bayoumi salama	Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS	assessment of pain	up to 3 months
Secondary	wexener scale	assess the constipation	up to 3 months