Infiltrations With Collagen in Episiotomy and Cesarean Scars
Condition: Pelvic Pain
MeSH terms: Pelvic Pain
Study type: Interventional

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).
    

Intervention name(s): Collagen; Rehabilitation sessions
Intervention type(s): Combination Product; Procedure
Intervention description(s): Patients will receive 3 to 5 collagen infiltrations in the scar once per week. Patients with episiotomy will receive 3 collagen infiltrations while patients who underwent a cesarean section will receive 5 collagen infiltrations. The infiltration will be done by tunneling technique, that is, it will be applied along the scar, placing the needle almost tangential to the entire length of the area, then it will be injected and at the same time the needle will be removed. Infiltrations will be carried out intradermally, previously performing asepsis in the area to be infiltrated. 2 ml syringes will be used to infiltrate the episiotomy scars (we will use 1 vial of 2 ml ) and 5 ml for cesarean scars (2 vials of 2 ml ) and sterile needles of 30G, 13mm.; Patients will receive the conventional treatment of 8 rehabilitation sessions with massage therapy techniques, muscle stretches and fascial work. The rehabilitation sessions will always be carried out by the same physiotherapist specialized in pelvic floor. There will be two sessions per week for four weeks. The sessions will last 45 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Episiotomy; Pain; Colagen