- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04793347
Effect of Shock Waves Therapy on Chronic Anal Fissure
Effect of Shock Waves Therapy on Anal Fissure
Study Overview
Status
Conditions
Intervention / Treatment
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..
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Giza, Egypt, 12613
- AMR
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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,
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: shock waves
group of patients with anal fissure will be treated with shock waves
|
device produces shock waves
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VAS
Time Frame: up to 3 months
|
assessment of pain
|
up to 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
wexener scale
Time Frame: up to 3 months
|
assess the constipation
|
up to 3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- nu5332
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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