Exploring the Effects of Soft Tissue Manual Therapy on the Viscoelastic Properties, Pressure Sensitivity and Touch Sensitivity of the Caesarean Section Scar
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 8
- 主要终点
- Viscoelastic properties: Stiffness
研究概览
简要总结
Introduction: Caesarean section is one of the most common inpatient surgical procedures. Complications of obstetric wounds are estimated to account for 2.8-26.6% of cases. Between 11 and 15% of women would develop pain and discomfort following a Caesarean section. Manual therapies may be an interesting non-pharmacological approach to treating the signs and symptoms of scarring complications following a Caesarean section. However, the current literature with an in vivo perspective remains modest results for the effects of tissue physiology and their effects on pain.
Method: Using an exploratory "proof of concept" type descriptive design with before and after measurements, the immediate and 7-day effects following the application of soft tissue manual therapy on the Caesarean section scar will be evaluated. The objectives are to describe and explore differences from the effects of soft tissue manual therapy on the viscoelastic properties, pressure sensitivity and touch sensitivity of the Caesarean section scar. Thirty-eight women aged between 18 and 40 years with a Caesarean section scar who attend first-line or specialized obstetrics and perinatal clinics will be recruited.
Anticipated results This project will document the viscoelastic characteristics, pressure sensitivity and touch sensitivity of the C-section scar and surrounding unhealed tissue to improve our understanding of the plausibility of the effects of manual therapy, an approach used to treat the signs and symptoms associated with C-section scarring.
详细描述
Methods of manual treatment of scars have demonstrated some effectiveness, although the effects and physiology by which mechanical forces of the therapist's hand provide benefits are poorly understood. This research will improve understanding of certain tissue characteristics and physiology elicited during treatment, and provide better conceptual explanations of the effects of manual therapies.
This study consists of 2 steps. The first step consists of the reliability of the Myoton Pro. The second step consists to describe and explore the effects of the soft tissue manual therapy on viscoelastic properties, touch sensibility and pressure sensibility on the Caesarean scar and the unscarred skin.
Objective(s)
The main objective of this project is to evaluate the effects of the application of mechanical force by the therapist's hand on the Caesarean section scar. The specific objectives are to document the following, prior to and following the application of mechanical force by the therapist's hand:
- Determine the reliability and discrimination of the Myoton Pro.
- The viscoelastic properties of the Caesarean section scar and surrounding healthy tissues;
- The sensitivity of the Caesarean section scar to pressure compared with surrounding healthy tissues;
- The touch sensitivity of the Caesarean section scar compared with surrounding healthy tissue; and
- Differences in viscoelastic properties, pressure sensitivity and touch sensitivity before and after the independent variable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Woman with a caesarean section scar of 6 months or more but less than two years old
- •with one or more caesarean sections
- •between the ages of 18 and 40
- •with a Pfannenstiel or transverse caesarean section.
排除标准
- •one of the following pathologies: diabetes or under treatment for cancer
- •on anti-inflammatory medication at the time of data collection or they have taken this type of medication in the month prior to data collection
- •applied a product or cream to their scar on the day of data collection
- •contraindications to their skin inductions
- •had a treatment (e.g., a treatment to prevent the development of cancer)
- •undergoing treatment (e.g. laser, massage or other local intervention) for their scar in the three months prior to the data collection.
结局指标
主要结局
Viscoelastic properties: Stiffness
时间窗: The change in stiffness is evaluated before and after the intervention. To evaluate this change, two visits each 7 days are required. Stiffness will be assessed at the beginning of each visit and following the intervention.
The MyotonPro allows the evaluation of five parameters. Stiffness (N/m) is manifested by the resistance to deformation induced by the applied force of the external mechanical arm.The MyotonPro is a portable device that induces a low-force external impulse from a small mechanical external arm. The pulse induces soft tissue oscillations. These are transformed under the force of an acceleration signal and allow the calculation of mechanical and viscoelastic tissue properties.
The viscoelastic properties: Elasticity
时间窗: The change in Elasticity is evaluated before and after the intervention. To evaluate this change, two visits each 7 days are required. Elasticity will be assessed at the beginning of each visit and following the intervention.
The MyotonPro allows the evaluation of five parameters. The MyotonPro is a portable device that induces a low-force external impulse from a small mechanical external arm. The pulse induces soft tissue oscillations. These are transformed under the force of an acceleration signal and allow the calculation of mechanical and viscoelastic tissue properties. The ability of the tissue to return to its initial shape characterises elasticity (D). This can be identified by the logarithmic decrement, i.e. the logarithmic measurement of the dissipation of mechanical energy induced by the external arm of the MyotonPro.
The viscoelasticity properties: Tone
时间窗: The change in tone is evaluated before and after the intervention. To evaluate this change, two visits each 7 days are required. Tone will be assessed at the beginning of each visit and following the intervention.
The MyotonPro is a portable device that induces a low-force external impulse from a small mechanical external arm. The pulse induces soft tissue oscillations. These are transformed under the force of an acceleration signal and allow the calculation of mechanical and viscoelastic tissue properties. The MyotonPro allows the evaluation of five parameters. The oscillation frequency (Hz) characterizes the resting tone, i.e. the intrinsic cell tension.
次要结局
- Touch sensitivity(The change in touch sensitivity is evaluated before and after the intervention. To evaluate this change, two visits each 7 days are required. Touch sensitivity will be assessed at the beginning of each visit and following the intervention.)
- Appearance of the caesarean section(The change in appearance is evaluated before the intervention. To evaluate this change, two visits each 7 days are required. Appearance will be assessed at the beginning of each visit.)
- Pressure sensitivity(The change in pressure is evaluated before and after the intervention. To evaluate this change, two visits each 7 days are required. Pressure will be assessed at the beginning of each visit and following the intervention.)
研究者
Isabelle Gilbert
Principal investigator
Université de Sherbrooke