Efficacy of Infiltrations With Collagen in Pelvic Pain Caused by Episiotomy and Cesarean Scars. Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Pain caused by the scar (VAS)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients between 18-45 years old.
- •Between 2 and 36 months post-partum
- •Accept participate in the study and sign the informed consent.
排除标准
- •Mental or cognitive disorder that prevents comprehension.
- •Being pregnant.
- •Pacemaker carriers.
- •On treatment with oral anticoagulants.
- •Local infections at the point of infiltration.
- •Total or partial denervation of the pelvic floor.
- •Neurological diseases: AVC, LM, MS.
研究组 & 干预措施
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.
干预措施: Collagen (Combination Product)
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.
干预措施: Rehabilitation sessions (Procedure)
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.
干预措施: Rehabilitation sessions (Procedure)
结局指标
主要结局
Pain caused by the scar (VAS)
时间窗: 6 weeks after the end of treatment
Pain caused by the scar according to the Visual Analogue Scale (VAS). Range 0 to 10. Higher values represent worse pain.
Pain caused by the scar (MPQ)
时间窗: 6 weeks after the end of treatment
Pain caused by the scar according to the Short Form McGill Pain (Questionnaire (MPQ). Range 0 to 78. Three dimensions: Sensory (12 ítems), Affective (3 ítems), Evaluative (1 ítem). Higher score higher level of pain.
次要结局
- Aspect of the scar (VSS)(6 weeks after the end of treatment)
- Aspect of the scar (PSAS)(6 weeks after the end of treatment)
- Subjective satisfaction of the clinician (PGI-I)(6 weeks after the end of treatment)
- Subjective satisfaction of the clinician (CGI-I)(6 weeks after the end of treatment)
研究者
Georgia Romero
Principal Investigator
Althaia Xarxa Assistencial Universitària de Manresa