Acute Effects of Radiofrequency Diathermy in Postpartum Women With Diastasis Abdominis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Pressure pain threshold
研究概览
简要总结
This clinical trial aims to compare the immediate tissue response in postpartum women with and without rectus abdominis diastasis (RAD) after undergoing radiofrequency diathermy (RFD) treatment. The main question it seeks to answer is: Do postpartum women with and without RAD exhibit different acute tissue responses in terms of pressure pain threshold, superficial thermal sensitivity, and tissue elasticity? To determine whether there are differences in these acute tissue responses between the groups, researchers will compare RFD with a sham RFD intervention in postpartum women with and without RAD.
Participants will receive one session of either RFD or a sham RFD intervention and will complete three assessments: one at baseline and two after the intervention, one immediately afterwards and one 20 minutes afterwards.
详细描述
A randomised controlled experimental study will be conducted. The sample will consist of 48 postpartum women: 24 who have been diagnosed with pathological RAD and 24 who have not. The participants will be randomly assigned to one of two groups: (i) a radiofrequency diathermy (RFD) group (n = 12), and (ii) a sham RFD group (n = 12). All participants will receive a single treatment session. Evaluations will be performed at three time points: baseline, immediately after the intervention and 20 minutes post-intervention. The variables assessed will include pressure pain threshold, superficial thermal sensitivity and tissue elasticity.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age between 20 and 45 years old.
- •BMI between 18.5 and 29.9 kg/mw.
- •Postpartum period between 6 months and 1 year Additionally, in the group of women with RAD, pathological RAD will be defined as an inter-rectus distance greater than 2.2 cm (measured 3 cm above the navel), according to the criteria of Beer et al. (2009)
排除标准
- •Previous surgeries involving the abdominal wall.
- •Cesarean deliveries.
- •Women diagnosed with chronic pain
研究组 & 干预措施
RFD women with RAD
Women with RAD will receive RFD for 20 minutes, with 10 minutes applied using the capacitive method and 10 minutes using the resistive method.
干预措施: Radiofrequency diathermy (RFD) (Other)
RFD women without RAD
Women without RAD will also receive RFD for 20 minutes, with 10 minutes applied using the capacitive method and 10 minutes using the resistive method
干预措施: Radiofrequency diathermy (RFD) (Other)
Sham RFD women with RAD
Women with RAD will receive 20 minutes of application of the RFD device without energy emission. 10 minutes using the capacitive electrode and 10 minutes using the resistive electrode.
干预措施: Sham radiofrequency diathermy ( sham RFD) (Other)
Sham RFD women without RAD
Women without RAD will likewise receive 20 minutes of application of the RFD device without energy emission. 10 minutes using the capacitive electrode and 10 minutes using the resistive electrode.
干预措施: Sham radiofrequency diathermy ( sham RFD) (Other)
结局指标
主要结局
Pressure pain threshold
时间窗: Baseline, immediately after the intervention and 20 minutes after the intervention.
The pressure pain threshold will be measured using an algometer by applying progressive force to a supraumbilical point (three centimetres above the navel, at the lateral border of the rectus abdominis on the dominant side) until the participant reports pain. A higher value indicates a higher pain threshold.
Superficial thermal sensitivity
时间窗: Baseline, immediately after the interventino and 20 minutes after the intervention
Superficial thermal sensitivity will be assessed using the Thermal Visual Analogue Scale. For this, the capacitive electrode will be placed over the rectus abdominis on both sides for 30 seconds. Participants will then rate their thermal sensation on a scale from 0 (no heat) to 10 (maximum tolerable heat).
Tissue elasticity
时间窗: Baseline, immediately after the interventino and 20 minutes after the intervention
The MyotonPRO® myometer will be used to measure tissue elasticity over the rectus abdominis on both sides. Higher values indicate greater stiffness and lower tissue elasticity.
次要结局
未报告次要终点
研究者
Marta Inglés de la Torre
Dr
University of Valencia