Effect of Shock Waves Therapy on Chronic Anal Fissure
- Conditions
- Chronic Anal Fissure
- Interventions
- Device: shock master (shock waves device)
- Registration Number
- NCT04793347
- Lead Sponsor
- amr bayoumi salama
- 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..
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- patient with chronic anal fissure
- symptomatic for at least 6 months
- failed conservative measures
- Pregnant women,
- cardiac patients,
- patients with a pacemaker,
- low molecular heparin or warfarin treatment,
- neurological disease,
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description shock waves shock master (shock waves device) group of patients with anal fissure will be treated with shock waves
- Primary Outcome Measures
Name Time Method VAS up to 3 months assessment of pain
- Secondary Outcome Measures
Name Time Method wexener scale up to 3 months assess the constipation
Trial Locations
- Locations (1)
Amr
🇪🇬Giza, Egypt