Infiltrations With Collagen in Episiotomy and Cesarean Scars

NCT ID: NCT04112888

Last Updated: 2019-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2018-04-01

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).

Conditions

Pelvic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Collagen group

Patients will receive 3 to 5 infiltrations of collagen on the scar once a week.

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. Two rehabilitation sessions per week during four weeks. The rehabilitation sessions will last 45 minutes.

Group Type: EXPERIMENTAL

Collagen

Intervention Type: COMBINATION_PRODUCT

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.

Rehabilitation sessions

Intervention Type: PROCEDURE

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.

Control group

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. Two rehabilitation sessions per week during four weeks. The rehabilitation sessions will last 45 minutes.

Group Type: ACTIVE_COMPARATOR

Rehabilitation sessions

Intervention Type: PROCEDURE

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.

Interventions

Collagen

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.

Intervention Type: COMBINATION_PRODUCT

Rehabilitation sessions

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Althaia Xarxa Assistencial Universitària de Manresa

OTHER

Sponsor Role: lead

Responsible Party

Georgia Romero

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Georgia Romero-Culleres, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Althaia Xarxa Assistencial Universitària de Manresa

Locations

Althaia Xarxa Assistencial Universitària de Manresa

Manresa, Barcelona, Spain

Countries

Spain

Other Identifiers

CEI 17/73

Identifier Type: -

Identifier Source: org_study_id