Effect of Shock Waves Therapy on Chronic Anal Fissure | NCT04793347

Studies
Effect of Shock Waves Therapy on Chronic Anal Fissure

NCT04793347

Sponsor

amr bayoumi salama

Status

Unknown status

Last Update Posted

Mar 11, 2021Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Chronic Anal Fissure

Interventions

shock master (shock waves device)

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 10, 2021Estimated

Primary Completion Date

Apr 30, 2021Estimated

Completion Date

May 30, 2021Estimated

First Submitted Date

Mar 6, 2021

First Submission Date that Met QC Criteria

Mar 9, 2021

First Posted Date

Mar 11, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2021

Last Update Posted Date

Mar 11, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

amr bayoumi salama, faculty of physical therapy. Cairo university, Cairo UniversitySponsor-Investigator

Lead Sponsor

amr bayoumi salamaOTHER

Collaborators

Name	Class
Cairo University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed 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..

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
shock waves	Experimental	group of patients with anal fissure will be treated with shock waves	Device: shock master (shock waves device)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
shock master (shock waves device)	Device	device produces shock waves	shock waves

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
VAS	assessment of pain	up to 3 months

Secondary Outcomes

Measure	Description	Time Frame
wexener scale	assess the constipation	up to 3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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,

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Amr		Giza		12613	Egypt