Effects of Soft Tissue Mobilization on Postsurgical Adhesions, Pain, Lumbopelvic Muscle Functions, Spinal Mobility, and Posture in Postpartum Women With Caesarean Section

Study Overview
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Brief Summary
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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

Official Title
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Effects of Soft Tissue Mobilization on Postsurgical Adhesions, Pain, Lumbopelvic Muscle Functions, Spinal Mobility, and Posture in Postpartum Women With Caesarean Section

Conditions
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Postsurgical Adhesion

Intervention / Treatment
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* Other: Myofascial abdominal diaphragm release
* Other: Direct focused scar release technique
* Other: Direct manipulations to visceral structures
* Other: pelvic anatomy education
* Other: sham


Participation Criteria
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Eligibility Criteria
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vaginal delivery Inclusion Criteria: Natural birth without C-section scar Postpartum more than 6 months Without any pain in the lumbopelvic region C-section Inclusion Criteria: Healed C-section scar > six months Scar with or without pain Both mode of delivery Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: deep and superficial tissue mobilization group<br>include deep and superficial tissue mobilization | Other: Myofascial abdominal diaphragm release<br>* Myofascial abdominal diaphragm release<br>Other: Direct focused scar release technique<br>* Direct focused scar release technique<br>Other: Direct manipulations to visceral structures<br>* Direct manipulations to visceral structures<br>Other: pelvic anatomy education<br>* pelvic anatomy education<br>|
| Active Comparator: superficial tissue mobilization group<br>superficial tissue mobilization | Other: Myofascial abdominal diaphragm release<br>* Myofascial abdominal diaphragm release<br>Other: Direct focused scar release technique<br>* Direct focused scar release technique<br>|
| Placebo Comparator: control group<br>Sham (very light hand touch on the same location as the other two groups but without any treatment intention) | Other: pelvic anatomy education<br>* pelvic anatomy education<br>Other: sham<br>* sham<br>|
| Other: vaginal delivery group<br>education session | Other: pelvic anatomy education<br>* pelvic anatomy education<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scar Characteristic: Extensibility | 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. | 8 weeks | 
| Scar Characteristic: Viscoelasticity | The biomechanical and viscoelastic properties of the scar tissue will be measured using a non-invasive myometer | 8 weeks | 
| Scar Characteristic: Irritability | 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. | 8 weeks | 
| Muscle function measures of lumbopelvic muscles | Ultrasonography image for muscle thickness of lumbopelvic muscles during rest and maximum contraction. | 8 weeks | 
| Muscle function measures of pelvic floor muscle control | Ultrasonography image for muscle thickness of pelvic floor muscle control during rest, maximum contraction | 8 weeks | 
| Spinal Mobility | 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 | 8 weeks | 
| Myofascial Flexibility | Straight leg raise test and Thomas test will be used to examine the muscle flexibility of the major lower extremity muscles. | 8 weeks | 
| Spinal Alignment and Posture | 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. | 8 weeks | 
| Pain intensity measure of Visual Analogue Scale | 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). | 8 weeks | 
| Pain intensity measure of pelvic girdle questionnaire | 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). | 8 weeks | 
| Pain intensity measure of Oswestry Low Back Pain Disability Questionnaire | 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. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-perceived Change Health Status: Global Rating of Change Scale (GROC) | The GROC is a single-item instrument that provides a means of measuring self-perceived change in health status. The GROC uses the 15-point Likert scale to rate the perceived overall change on a continuum, with -7 (labeled worse) on the left and +7 (labeled better) on the right, and 0 in the middle (labeled no change), compared with the baseline | 8 weeks | 
| Patient and Observer Scar Assessment Scale (POSAS) | The POSAS includes 2 numerical numeric scales: The Patient Scar Assessment Scale and the Observer Scar Assessment Scale. It objectively assesses vascularity, pigmentation, thickness, relief, pliability, and surface area, and incorporates patient subjective symptoms of pain, itching, color, stiffness, thickness, and relief. | 8 weeks |