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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51475

Enrollment

Registered

2022-12-07

Start date

2023-01-01

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

episiotomy vaginal cut

Interventions

All participants receive a total of 7 MCRRF session treatments at a rate of 1 session per week.

Eligibility

Age

16 Years to 64 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The primary endpoint the feasibility of a trial with MCRRF therapy in women with persisting perineal pain after episiotomy. Feasibility will be assessed by recruitment, retention and satisfaction.	—

Secondary

Measure	Time frame
The secondary endpoint is to explore the potential pain-reducing effects of MCRRF therapy using VAS scores.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)