Effects of Soft Tissue Mobilization on Postsurgical Adhesions, Pain, Lumbopelvic Muscle Functions, Spinal Mobility, and Posture in Postpartum Women With Caesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Scar Characteristic: Extensibility
研究概览
简要总结
Postpartum women with C-section receiving deep and superficial tissue mobilization would have better improvement on pain, lumbopelvic muscle functions, spinal mobility, and posture compare to the superficial tissue mobilization and control group
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •vaginal delivery
- •Inclusion Criteria:
- •Natural birth without C-section scar
- •Postpartum more than 6 months
- •Without any pain in the lumbopelvic region
- •Inclusion Criteria:
- •Healed C-section scar > six months
- •Scar with or without pain
- •Both mode of delivery
排除标准
- •Active infection or infectious disease in the pelvis or abdomen
- •Pain medications on days of measurements
- •Skin irritation and inflammation at the site of the scar
- •Currently pregnant or actively trying to get pregnant
- •History of radiation to the area
- •Any fracture around spine and pelvis
- •Any previous gynecologic and obstetric surgery
研究组 & 干预措施
deep and superficial tissue mobilization group
include deep and superficial tissue mobilization
干预措施: Direct focused scar release technique (Other)
deep and superficial tissue mobilization group
include deep and superficial tissue mobilization
干预措施: Direct manipulations to visceral structures (Other)
deep and superficial tissue mobilization group
include deep and superficial tissue mobilization
干预措施: pelvic anatomy education (Other)
superficial tissue mobilization group
superficial tissue mobilization
干预措施: Myofascial abdominal diaphragm release (Other)
superficial tissue mobilization group
superficial tissue mobilization
干预措施: Direct focused scar release technique (Other)
control group
Sham (very light hand touch on the same location as the other two groups but without any treatment intention)
干预措施: pelvic anatomy education (Other)
control group
Sham (very light hand touch on the same location as the other two groups but without any treatment intention)
干预措施: sham (Other)
vaginal delivery group
education session
干预措施: pelvic anatomy education (Other)
deep and superficial tissue mobilization group
include deep and superficial tissue mobilization
干预措施: Myofascial abdominal diaphragm release (Other)
结局指标
主要结局
Scar Characteristic: Extensibility
时间窗: 8 weeks
The extensibility of the scar will be measured using the modified adheremeter in each of 4 directions including superior, inferior, medial and lateral and then the area of mobility will be calculated.
Muscle function measures of lumbopelvic muscles
时间窗: 8 weeks
Ultrasonography image for muscle thickness of lumbopelvic muscles during rest and maximum contraction.
Muscle function measures of pelvic floor muscle control
时间窗: 8 weeks
Ultrasonography image for muscle thickness of pelvic floor muscle control during rest, maximum contraction
Myofascial Flexibility
时间窗: 8 weeks
Straight leg raise test and Thomas test will be used to examine the muscle flexibility of the major lower extremity muscles.
Pain intensity measure of Visual Analogue Scale
时间窗: 8 weeks
Visual Analogue Scale is a self-reported instrument assessing average pain intensity in currently. Possible score range from 0 (no pain) to 10 (worst possible pain).
Pain intensity measure of Oswestry Low Back Pain Disability Questionnaire
时间窗: 8 weeks
Oswestry Low Back Pain Disability Questionnaire is a self-reported instrument assessing patient's permanent functional disability in currently. For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. The higher the score, the greater the degree of disability.
Scar Characteristic: Irritability
时间窗: 8 weeks
The irritability of the scar will be measured using the digital pressure algometer for two conditions: first, when the pressure turns from discomfort to pain and the participant asks to stop, and then when the maximal pressure or pain the participant can tolerate.
Spinal Alignment and Posture
时间窗: 8 weeks
Radiographic measurement, posture will be assessed using the photographic measurement. Reflective markers will first be placed and attached on the canthus of the eye, tragus of the ear, the spinous processes of C2, C7, T1, T3, T11, T12, L1, L5, S1, S5, and bilateral anterior superior iliac spine and posterior superior iliac spine in standing. The participants will be instructed to maintain their gaze straight ahead at a target adjusted for body height. Two standing photographs will be taken, one in the usual standing posture and the other in the best standing posture. Following the other two photographs will be taken, one in maximal pelvic anterior tilt and the other in the maximal pelvic posterior tilt.
Scar Characteristic: Viscoelasticity
时间窗: 8 weeks
The biomechanical and viscoelastic properties of the scar tissue will be measured using a non-invasive myometer
Pain intensity measure of pelvic girdle questionnaire
时间窗: 8 weeks
pelvic girdle questionnaire is a self-reported instrument assessing pelvic girdle pain intensity in currently. Questionnaire consisting of 20 activity items and 5 symptom items on a 4-point response scale. Possible score range from 0 (no pain) to 100 (worst possible pain).
Spinal Mobility
时间窗: 8 weeks
Range of motion for cervical, thoracic, and lumbar spine in the sagittal, frontal, and transverse plane as well as pelvic tilt will be assessed using the wireless double inclinometers
次要结局
- Self-perceived Change Health Status: Global Rating of Change Scale (GROC)(8 weeks)
- Patient and Observer Scar Assessment Scale (POSAS)(8 weeks)
研究者
YI-JU TSAI
professor
National Cheng Kung University