To evaluate the pain reducing effect of MCRRF therapy in women with persisting perineal pain after episiotomy using Visual Analogue Scale (VAS) scores.
ID
Source
Brief title
Condition
- Postpartum and puerperal disorders
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is to compare VAS scores before and after MCRRF therapy.
Secondary outcome
Secondary endpoints are reassumption of sexual intercourse and analgesics
intake.
Background summary
Episiotomy is the most frequently performed operative procedure during
delivery. Perineal pain after episiotomy usually resolves within a few weeks,
but 13-23% of the women still report pain symptoms 6 weeks after delivery.
There is limited information about the management of persisting pain after
episiotomy. Recent research shows promising results of Monopolar Capacitive
Resistive Radiofrequency (MCRRF) therapy at 448 kHz in the treatment of various
chronic pain conditions. We hypothesize that MCRRF therapy is a possible
treatment modality for women with persisting pain in the pelvic floor region
after episiotomy.
Study objective
To evaluate the pain reducing effect of MCRRF therapy in women with persisting
perineal pain after episiotomy using Visual Analogue Scale (VAS) scores.
Study design
An exploratory, prospective single-arm single-centre trial
Intervention
All participants receive a total of 7 MCRRF treatments at a rate of 1 session
per week.
Study burden and risks
Patients enrolled in this study will receive a total of 6 MCRRF treatments, at
a frequency of 1 session per week. Before and after the intervention, subjects
are asked to complete a questionnaire. MCCRF therapy is considered safe and is
already used in a variety of chronic pain conditions, with no serious risks
reported in literature. Furthermore, the reported risks, such as skin
irritation and superficial burns, are minimal when the therapy is given by
certified pelvic physiotherapists.
Montessoriweg 1
Rotterdam 3083AN
NL
Montessoriweg 1
Rotterdam 3083AN
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL77865.028.21 |