Clinical trial NCT04112888: Infiltrations With Collagen in Episiotomy and Cesarean Scars
Official title: Efficacy of Infiltrations With Collagen in Pelvic Pain Caused by Episiotomy and Cesarean Scars. Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Pain
Keywords: Episiotomy
Pain
Colagen
Lead sponsor: Althaia Xarxa Assistencial Universitària de Manresa
Sponsor class: OTHER
First posted: 2019-10-02
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: One of the causes of pelvic pain is secondary to scarring due to episiotomy or cesarean after delivery.The pain of episiotomies or cesarean scars can be generalized at the level of the perineum, or more specifically at the level of the scar. For all these reasons, the presence of painful scars after a delivery, either by a cesarean or an episiotomy produces a perception of pelvic pain and change is your body schema and a series of negative connotations such as secondary dyspareunia, affective alterations, etc.

To this, the investigators must add the important role that the psychological and social aspects can play in the development and perpetuation of a pain of these characteristics.

The perception of pain is subjective and its intensity will be perceived based on many variables in each individual. The psycho-corporal representation of the episiotomy and/or cesarean section and its consequences will depend on each woman. In addition to the physical aspect, the scar of the episiotomy is the testimony of the birth and its complications. It causes a change in the representation of the body and the sex of the patient.

The objective of this study is to evaluate the efficacy of collagen infiltrations in pelvic pain and the appearance of painful scars of episiotomies and/or cesareans compared to conventional treatment with rehabilitation.

Detailed description: Randomized clinical trial to evaluate the efficacy of collagen infiltrations in pelvic pain caused by cesarean scars and/or episiotomies.

Those patients who are referred to the Rehabilitation consultation for pelvic pain secondary to pain in the cesarean/episiotomy scar who meet the inclusion criteria and who agree to participate and sign the informed consent will be included.

In the baseline assessment, the patient's clinical information will be collected: age, obstetric history, pathological history, active treatments and if they breastfeed. The following questionnaires will be passed: the Visual Analogue Scale (VAS) and the Short Form McGill Pain Questionnaire (SF-MPQ) to evaluate the pain caused by the scar, the Vancouver Scale of Healing (VSS) and the Patient Component (PSAS) of the Patient and Observer Objective Assessment Scale (POSAS) for the evaluation of the scar and initial photograph of the scar. A physical examination of the pelvic floor will be performed and the areas to be infiltrated will be detected.

Patients will be randomly assigned to a Control group, will perform the conventional treatment, and an Experimental Group, who will perform the conventional treatment and will also have 3-5 infiltrations with collagen.

At 6 and 16 weeks to finalize the treatment, a blinded assessor will perform the final assessment by passing the questionnaires used in the baseline assessment. The subjective satisfaction of the clinician and the patient will also be assessed using the questionnaires Clinical Global Improvement Impression Scale (GGI-I) and the Patient Global Improvement Impression Scale (PGI-I).

Eligibility criteria: Inclusion Criteria:

1. Patients between 18-45 years old.
2. Between 2 and 36 months post-partum
3. Accept participate in the study and sign the informed consent.

Exclusion Criteria:

1. Mental or cognitive disorder that prevents comprehension.
2. Being pregnant.
3. Pacemaker carriers.
4. On treatment with oral anticoagulants.
5. Local infections at the point of infiltration.
6. Total or partial denervation of the pelvic floor.
7. Neurological diseases: AVC, LM, MS.

Primary outcomes:
measure: Pain caused by the scar (VAS)
timeFrame: 6 weeks after the end of treatment
measure: Pain caused by the scar (MPQ)
timeFrame: 6 weeks after the end of treatment
Secondary outcomes:
measure: Aspect of the scar (VSS)
timeFrame: 6 weeks after the end of treatment
measure: Aspect of the scar (PSAS)
timeFrame: 6 weeks after the end of treatment
measure: Subjective satisfaction of the clinician (PGI-I)
timeFrame: 6 weeks after the end of treatment
measure: Subjective satisfaction of the clinician (CGI-I)
timeFrame: 6 weeks after the end of treatment
Other outcomes:
Locations:
city: Manresa
country: Spain
facility: Althaia Xarxa Assistencial Universitària de Manresa
state: Barcelona
Study officials:
affiliation: Althaia Xarxa Assistencial Universitària de Manresa
name: Georgia Romero-Culleres, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: