EPIPAIN trial: Radiofrequency therapy at 448 kHz for persisting pain after episiotomy - a feasibility study

• Conditions: episiotomy; vaginal cut; 10036411; 10029903

• Registration Number: NL-OMON51475
• Lead Sponsor: Ikazia Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1. Age > 18 years
2. Persisting pain in the pelvic floor region (VAS-score > 4) after a
mediolateral episiotomy
3. At least 6 weeks after delivery

Exclusion Criteria

1. Signs of infection of the episiotomy wound
2. Pacemaker or other electronical implant
3. Nickel allergy
4. Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint the feasibility of a trial with MCRRF therapy in women<br /><br>with persisting perineal pain after episiotomy. Feasibility will be assessed by<br /><br>recruitment, retention and satisfaction. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoint is to explore the potential pain-reducing effects of<br /><br>MCRRF therapy using VAS scores. </p><br>