To evaluate the feasibility of MCRRF therapy in women with persisting perineal pain after episiotomy. Collection of pilot data is essential in the preparation of a larger randomized-controlled trial that investigates the efficacy of MCRRF therapy.
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 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 outcome
The secondary endpoint is to explore the potential pain-reducing effects of
MCRRF therapy using VAS scores.
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 feasibility of MCRRF therapy in women with persisting perineal
pain after episiotomy. Collection of pilot data is essential in the preparation
of a larger randomized-controlled trial that investigates the efficacy of MCRRF
therapy.
Study design
An exploratory, prospective single-arm single-centre trial
Intervention
All participants receive a total of 7 MCRRF session treatments at a rate of 1
session per week.
Study burden and risks
Patients enrolled in this study will receive a total of 7 MCRRF session
treatments, at a frequency of 1 session per week. Before and after the
intervention, subjects are asked to complete a questionnaire including pain
scores. MCRRF 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
Medical products/devices used
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 | NL81426.100.22 |